T-cell Childhood Acute Lymphoblastic LeukemiaNCT00016302
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A study testing prednisone, vincristine sulfate and daunorubicin hydrochloride in people with T-cell Childhood Acute Lymphoblastic Leukemia and Untreated Childhood Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- prednisone, vincristine sulfate and daunorubicin hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
- High-risk disease, defined as meeting at least 1 of the following criteria:
- WBC at least 50,000/mm^3
- Age 10 years or over
- Patients with WBC at least 25,000/mm^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
- Concurrent registration to POG 9900 within the past 8 days required
Show all 22Show fewer
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
- See Disease Characteristics
- Bilirubin no greater than 1.5 mg/dL
- SGPT less than 5 times normal
- Creatinine normal
- Creatinine clearance or glomerular filtration rate at least 60 mL/min
- No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior biologic therapy
- No more than 72 hours since prior intrathecal cytarabine
- No other prior chemotherapy
- Prior steroids allowed
- No chronic steroid treatment for another disease
- Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of the addition of nelarabine to modified multiagent Berlin-Frankfurt-Muenster-86 chemotherapy in patients with newly diagnosed T-cell acute lymphoblastic leukemia.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetics and intracellular pharmacology of nelarabine in these patients.
OUTLINE: This is a pilot, multicenter study.
Prednisone Response Pre-Induction: All patients receive oral prednisone three times daily on days -7 to -1 and methotrexate intrathecally (IT) on day -7* of week 0. Good prednisone responders proceed to induction on regimen A. Poor prednisone responders proceed to induction on regimen C.
NOTE: *Patients who have received cytarabine IT within the week prior to study entry receive methotrexate IT on day -6.
Regimen A (good prednisone responders) (closed as of 2/27/03):
Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone three times daily on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; asparaginase intramuscularly (IM) on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.
If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Those patients with minimal residual disease (MRD) on day 36 proceed to regimen B.
Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 63; cytarabine IV over 72 hours on days 38-40, 45-47, 52-54, and 59-61; oral mercaptopurine daily on days 36-63; and methotrexate IT on days 45 and 59.
Consolidation (weeks 10-19): Patients receive oral mercaptopurine on days 64-119; methotrexate IV over 24 hours and leucovorin calcium IV, or orally as tolerated, on days 71, 85, 99, and 113; and methotrexate IT on days 71, 85, 99, and 113. (Patients begin methotrexate once blood counts recover and only if bone marrow is M1).
Reinduction (weeks 20-29): Patients receive oral dexamethasone three times daily on days 134-154; vincristine IV on days 141 and 148; doxorubicin IV over 15 minutes on days 134, 141, 148, and 155; and asparaginase IM on days 141, 144, 148, 151, 154, and 157. Beginning on day 169 or when blood counts recover, patients receive cyclophosphamide IV on day 169, cytarabine IV over 72 hours on days 171-173 and 178-180; oral thioguanine daily on days 169-182; and methotrexate IT on days 171 and 178. Patients also receive cranial irradiation for up to 10 days beginning on day 189.
Maintenance (weeks 30-101): Patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 9 courses.
Regimen B (patients with MRD on day 36 of regimen A) (closed as of 2/27/03):
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
Regimen C (poor prednisone responders from stage 1 of study and all patients entered during stage 2 of study) (closed as of 2/27/03):
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
Regimen D (effective 5/2004):
Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone 3 times a day on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; nelarabine IV over 1 hour on days 29-33; asparaginase IM on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.
If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 50; cytarabine IV or SC on days 36-39, 43-46, 50-53, and 57-60; oral mercaptopurine once daily on days 36-63; and methotrexate IT on days 43 and 57.
Patients who are poor responders to prednisone in induction therapy proceed to regimen F. Patients who are good responders to prednisone but have MRD after induction therapy proceed to regimen E. Patients who are good responders to prednisone and have no MRD after induction therapy continue therapy on regimen D.
Consolidation (weeks 10-19): Patients must have M1 marrow to proceed. Patients receive oral mercaptopurine on days 70-126; methotrexate IV over 24 hours on days 77, 84, 91, and 98; leucovorin calcium IV or orally every 6 hours on days 78-79, 85-86, 92-93, and 99-100; and methotrexate IT on days 77, 84, 91, and 98.
Reinduction (weeks 20-29): Patients < 13 years old receive dexamethasone 3 times daily on days 140-161. Patients ≥ 13 years old receive oral dexamethasone on days 140-146 and 155-161; nelarabine IV on days 169-173; vincristine IV over 15 minutes on days 140, 147, and 153; pegaspargase IM on day 143; cyclophosphamide IV on day 176; cytarabine IV or SC on days 176-179 and 183-186; oral thioguanine on days 176-189; and methotrexate IT on days 176 and 183. Patients with CNS disease undergo craniocervical radiotherapy beginning on day 196 and continuing for 7-10 days.
Maintenance (weeks 30-61): Patients receive oral mercaptopurine on days 1-28 and 36-56; oral methotrexate on days 1, 8, 15, 22, 36, 43, and 50; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses.
Maintenance (weeks 62-101): Patients receive vincristine IV on day 1; oral dexamethasone twice daily on days 1-5; oral mercaptopurine on days 1-56; and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment repeats every 8 weeks for 5 courses.
Regimen E (good responders to induction prednisone but with MRD) (effective 5/2004): Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
Regimen F (poor responders to induction prednisone) (effective 5/2004): Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (30 for regimens A, B, and C; 70 for regimens D, E, and F) will be accrued for this study within 9-29 months.
- Conditions
- T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
- Being tested
- prednisone, vincristine sulfate, daunorubicin hydrochloride, asparaginase, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoneDrug
Also called DeCortin, Deltra
Given orally
Also called leurocristine sulfate, VCR, Vincasar PFS
Given IV
daunorubicin hydrochlorideDrug
Also called Cerubidin, Cerubidine, daunomycin hydrochloride, daunorubicin
Given IV
asparaginaseDrug
Also called ASNase, Colaspase, Crasnitin, Elspar
Given IM
methotrexateDrug
Also called amethopterin, Folex, methylaminopterin, Mexate
Given IT and orally
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
cytarabineDrug
Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U
Given IV or SC
mercaptopurineDrug
Also called 6-mercaptopurine, 6-MP, Leukerin, MP
Given orally
Also called CF, CFR, LV
Given IV or orally
dexamethasoneDrug
Also called Aeroseb-Dex, Decaderm, Decadron, DM
Given orally
Also called ADM, ADR, Adria, Adriamycin PFS
Given IV
thioguanineDrug
Also called 6-TG
Given orally
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo cranial irradiation
nelarabineDrug
Also called 506U78, Arranon, GW506U78
Given IV
pegaspargaseDrug
Also called L-asparaginase with polyethylene glycol, Oncaspar, PEG-ASP, PEG-L-asparaginase
Given IM
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo craniocervical radiotherapy
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | See detailed description. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis |
| Regimen B | Experimental | Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Drug: nelarabine; Other: pharmacological study; Other: laboratory biomarker analysis |
| Regimen C | Experimental | Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Drug: nelarabine; Other: pharmacological study; Other: laboratory biomarker analysis |
| Regimen D | Experimental | See detailed description. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis |
| Regimen E | Experimental | Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis |
| Regimen F | Experimental | Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E. Receives: Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Childhood Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kimberly Dunsmore, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016302
- Sponsor's protocol ID
- NCI-2012-01857
- Other IDs
- COG-AALL00P2, U10CA098543, CDR0000068620
- Status last verified
- Jan 2013
- First submitted
- 6 May 2001
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia
- ClinicalTrials.gov ID
- NCT00016302
- Acronym / sponsor ID
- NCI-2012-01857
- Conditions
- T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Jul 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia
Detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of the addition of nelarabine to modified multiagent Berlin-Frankfurt-Muenster-86 chemotherapy in patients with newly diagnosed T-cell acute lymphoblastic leukemia.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetics and intracellular pharmacology of nelarabine in these patients.
OUTLINE: This is a pilot, multicenter study.
Prednisone Response Pre-Induction: All patients receive oral prednisone three times daily on days -7 to -1 and methotrexate intrathecally (IT) on day -7* of week 0. Good prednisone responders proceed to induction on regimen A. Poor prednisone responders proceed to induction on regimen C.
NOTE: *Patients who have received cytarabine IT within the week prior to study entry receive methotrexate IT on day -6.
Regimen A (good prednisone responders) (closed as of 2/27/03):
Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone three times daily on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; asparaginase intramuscularly (IM) on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.
If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Those patients with minimal residual disease (MRD) on day 36 proceed to regimen B.
Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 63; cytarabine IV over 72 hours on days 38-40, 45-47, 52-54, and 59-61; oral mercaptopurine daily on days 36-63; and methotrexate IT on days 45 and 59.
Consolidation (weeks 10-19): Patients receive oral mercaptopurine on days 64-119; methotrexate IV over 24 hours and leucovorin calcium IV, or orally as tolerated, on days 71, 85, 99, and 113; and methotrexate IT on days 71, 85, 99, and 113. (Patients begin methotrexate once blood counts recover and only if bone marrow is M1).
Reinduction (weeks 20-29): Patients receive oral dexamethasone three times daily on days 134-154; vincristine IV on days 141 and 148; doxorubicin IV over 15 minutes on days 134, 141, 148, and 155; and asparaginase IM on days 141, 144, 148, 151, 154, and 157. Beginning on day 169 or when blood counts recover, patients receive cyclophosphamide IV on day 169, cytarabine IV over 72 hours on days 171-173 and 178-180; oral thioguanine daily on days 169-182; and methotrexate IT on days 171 and 178. Patients also receive cranial irradiation for up to 10 days beginning on day 189.
Maintenance (weeks 30-101): Patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 9 courses.
Regimen B (patients with MRD on day 36 of regimen A) (closed as of 2/27/03):
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
Regimen C (poor prednisone responders from stage 1 of study and all patients entered during stage 2 of study) (closed as of 2/27/03):
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
Regimen D (effective 5/2004):
Induction (weeks 1-5): Patients receive vincristine IV on days 1, 8, and 15; oral prednisone 3 times a day on days 1-14; daunorubicin IV over 15 minutes on days 1, 8, 15, and 22; nelarabine IV over 1 hour on days 29-33; asparaginase IM on days 12, 15, 18, 22, 24, 27, 30, and 33; and methotrexate IT on day 1.
If bone marrow is M1, week 6 of induction therapy begins on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive cyclophosphamide IV over 1 hour on days 36 and 50; cytarabine IV or SC on days 36-39, 43-46, 50-53, and 57-60; oral mercaptopurine once daily on days 36-63; and methotrexate IT on days 43 and 57.
Patients who are poor responders to prednisone in induction therapy proceed to regimen F. Patients who are good responders to prednisone but have MRD after induction therapy proceed to regimen E. Patients who are good responders to prednisone and have no MRD after induction therapy continue therapy on regimen D.
Consolidation (weeks 10-19): Patients must have M1 marrow to proceed. Patients receive oral mercaptopurine on days 70-126; methotrexate IV over 24 hours on days 77, 84, 91, and 98; leucovorin calcium IV or orally every 6 hours on days 78-79, 85-86, 92-93, and 99-100; and methotrexate IT on days 77, 84, 91, and 98.
Reinduction (weeks 20-29): Patients < 13 years old receive dexamethasone 3 times daily on days 140-161. Patients ≥ 13 years old receive oral dexamethasone on days 140-146 and 155-161; nelarabine IV on days 169-173; vincristine IV over 15 minutes on days 140, 147, and 153; pegaspargase IM on day 143; cyclophosphamide IV on day 176; cytarabine IV or SC on days 176-179 and 183-186; oral thioguanine on days 176-189; and methotrexate IT on days 176 and 183. Patients with CNS disease undergo craniocervical radiotherapy beginning on day 196 and continuing for 7-10 days.
Maintenance (weeks 30-61): Patients receive oral mercaptopurine on days 1-28 and 36-56; oral methotrexate on days 1, 8, 15, 22, 36, 43, and 50; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses.
Maintenance (weeks 62-101): Patients receive vincristine IV on day 1; oral dexamethasone twice daily on days 1-5; oral mercaptopurine on days 1-56; and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, and 50. Treatment repeats every 8 weeks for 5 courses.
Regimen E (good responders to induction prednisone but with MRD) (effective 5/2004): Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
Regimen F (poor responders to induction prednisone) (effective 5/2004): Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 100 patients (30 for regimens A, B, and C; 70 for regimens D, E, and F) will be accrued for this study within 9-29 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: thioguanine, Radiation: radiation therapy, Other: pharmacological study, Other: laboratory biomarker analysisSee detailed description. |
| Regimen B | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: thioguanine, Radiation: radiation therapy, Drug: nelarabine, Other: pharmacological study, Other: laboratory biomarker analysisInduction (weeks 1-9): Patients receive treatment as in induction of regimen A. Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A. Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166. Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses. |
| Regimen C | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: doxorubicin hydrochloride, Drug: thioguanine, Radiation: radiation therapy, Drug: nelarabine, Other: pharmacological study, Other: laboratory biomarker analysisInduction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33. If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A. Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A. Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B. Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B. |
| Regimen D | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: thioguanine, Drug: nelarabine, Drug: pegaspargase, Radiation: radiation therapy, Other: pharmacological study, Other: laboratory biomarker analysisSee detailed description. |
| Regimen E | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: thioguanine, Drug: nelarabine, Drug: pegaspargase, Radiation: radiation therapy, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose. |
| Regimen F | Experimental | Drug: prednisone, Drug: vincristine sulfate, Drug: daunorubicin hydrochloride, Drug: asparaginase, Drug: methotrexate, Drug: cyclophosphamide, Drug: cytarabine, Drug: mercaptopurine, Drug: leucovorin calcium, Drug: dexamethasone, Drug: thioguanine, Drug: nelarabine, Drug: pegaspargase, Radiation: radiation therapy, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
- Patients with WBC at least 25,000/mm^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
- Concurrent registration to POG 9900 within the past 8 days required
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prednisoneAlso: DeCortin, DeltraGiven orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| vincristine sulfateAlso: leurocristine sulfate, VCR, Vincasar PFSGiven IV | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| daunorubicin hydrochlorideAlso: Cerubidin, Cerubidine, daunomycin hydrochloride, daunorubicinGiven IV | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| asparaginaseAlso: ASNase, Colaspase, Crasnitin, ElsparGiven IM | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| methotrexateAlso: amethopterin, Folex, methylaminopterin, MexateGiven IT and orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| cytarabineAlso: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-UGiven IV or SC | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| mercaptopurineAlso: 6-mercaptopurine, 6-MP, Leukerin, MPGiven orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| leucovorin calciumAlso: CF, CFR, LVGiven IV or orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| dexamethasoneAlso: Aeroseb-Dex, Decaderm, Decadron, DMGiven orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| doxorubicin hydrochlorideAlso: ADM, ADR, Adria, Adriamycin PFSGiven IV | Drug | Regimen A, Regimen B, Regimen C |
| thioguanineAlso: 6-TGGiven orally | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo cranial irradiation | Radiation | Regimen A, Regimen B, Regimen C |
| nelarabineAlso: 506U78, Arranon, GW506U78Given IV | Drug | Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| pegaspargaseAlso: L-asparaginase with polyethylene glycol, Oncaspar, PEG-ASP, PEG-L-asparaginaseGiven IM | Drug | Regimen D, Regimen E, Regimen F |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo craniocervical radiotherapy | Radiation | Regimen C, Regimen D, Regimen E, Regimen F |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
| laboratory biomarker analysisCorrelative studies | Other | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
Primary outcome
Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Dunsmore principal investigator
Children's Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisone, vincristine sulfate and daunorubicin hydrochloride in people with T-cell Childhood Acute Lymphoblastic Leukemia and Untreated Childhood Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0 (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.