LeukemiaPhase 3NCT00707083
Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 3 study testing dexamethasone, mercaptopurine and methotrexate in people with Leukemia, run by Prince of Wales Hospital, Shatin, Hong Kong at 2 sites in China.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leukemia
- What is being tested?
- dexamethasone, mercaptopurine and methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,231 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2008to 1 Mar 2020
- Phase
- Phase 3
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:
- Standard-risk disease:
- Age 1 to 9 years
- White blood cell (WBC) < 50/mm^3 OR t(12;21) or molecular fusion product -positive disease
- Good response to prior prednisone (day 8 peripheral blood blast < 1,000/mm^3)
- None of the following subtypes:
- T-cell
- t(9;22)
- t(4;11)
- t(1;19)
- Molecular
- Bone marrow (BM) M1 or M2 on day 15, BM remission (< 5% blast) on day 33
- Intermediate-risk disease:
- Good response to prior prednisone
- BM M1/M2 on day 15
- Meets 1 of the following criteria:
- At least 10 years old
- WBC > 50/mm^3
- Under 1 year old without Mixed Lineage Leukemia (MLL) gene rearrangement
- T-cell OR t(1;19) or molecular fusion product positive.
- Standard-risk patient with BM M3 on day 15
- If minimal residual disease (MRD) available, day 33 MRD < 10^-2
- High-risk disease, meeting 1 of the following criteria:
- Poor response to prior prednisone
- t(9;22) or molecular fusion product (BCR/ABL1), t(4;11) or molecular fusion product (MLL/AF4)
- Intermediate-risk patient with BM M3 on day 15
- BM M2/M3 on day 33
- If MRD available, flow cytometry/polymerase chain reaction (PCR) > 10% on days 15 OR MRD > 10^-2 on day 33 OR MRD (before mini-M phase or M phase) > 10^-3 on day 84
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
China2 sites
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital - Hong Kong
Hong Kong
About this study
Official title: A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Compare the incidence of marrow suppression with 2 methods of maintenance treatment in children with acute lymphoblastic leukemia.
- Compare the incidence of liver toxicity with 2 methods of maintenance treatment in these patients.
Secondary
- Determine any difference in infection rates and related hospitalizations in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs intermediate vs standard), age in years (0 to 5 vs 6 to 9 vs 10 to 17), and sex.
- Patients with standard-risk disease:
- Induction therapy: Patients receive prednisolone IV or orally three times daily on days 1-7; oral dexamethasone three times daily on days 8-28; asparaginase IV over 1 hour or intramuscularly once on days 8, 11, 14, 17, 20, 23, 26, and 29; vincristine IV once on days 8, 15, 22, and 29; daunorubicin hydrochloride IV over 1 hour on days 8 and 15; and methotrexate intrathecally (IT) once on days 1, 15, and 33.
- Early intensification (EI) therapy: Patients receive cyclophosphamide IV over 1 hour on day 36, cytarabine IV continuously on days 38-41 and 45-48, oral mercaptopurine once daily on days 36-50, and methotrexate IT on days 38 and 45.
- Consolidation therapy: Two weeks after completing EI therapy, patients receive oral mercaptopurine once daily on days 1-56 and methotrexate IV over 24 hours and IT on days 8, 22, 36, and 50.
- Delayed intensification (DI) therapy:
- DI/a: Patients receive dexamethasone orally or IV three times daily on days 1-7 and 15-21, doxorubicin hydrochloride IV over 1 hour on days 1, 8, and 15; vincristine IV on days 1, 8, and 15; and asparaginase subcutaneously (SC) or IV over 1 hour on days 1, 4, 8, and 11.
- DI/b: Patients receive cyclophosphamide IV over 1 hour on day 29, cytarabine IV continuously on days 31-34 and 38-41, oral thioguanine once daily on days 29-42, and methotrexate IT on days 31 and 38.
- Maintenance therapy: Patients are randomized to one of two treatment arms. Patients who do not consent for randomization receive conventional therapy (arm I).
- Arm I (conventional): Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 courses for girls or 11 courses for boys.
- Arm II (intervention): Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
- Patients with intermediate-risk disease:
- Induction therapy: Patients receive prednisolone, dexamethasone, and asparaginase as in standard-risk induction therapy. Patients also receive vincristine IV and daunorubicin hydrochloride IV over 1 hour on days 8, 15, 22, and 29; methotrexate IT on day 1; and triple intrathecal therapy (TIT; high-dose methotrexate, cytarabine, hydrocortisone sodium succinate) on days 15 and 33.
- First EI therapy: Patients receive cyclophosphamide, cytarabine, and mercaptopurine as in standard-risk EI. Patients also receive TIT on day 38.
- Second EI therapy: Beginning 2 weeks after completing first EI, patients receive cyclophosphamide over 1 hour on day 1, oral mercaptopurine on days 1-14, cytarabine IV on days 3-6 and 10-13, and TIT on day 3.
- Consolidation therapy: Beginning 2 weeks after completing second EI, patients receive mercaptopurine as in standard-risk consolidation therapy. Patients also receive methotrexate IV over 24 hours and TIT on days 8, 22, 36, and 50.
- First DI therapy: Patients receive treatment as in standard-risk DI.
- Interim maintenance therapy: Patients receive oral mercaptopurine and oral methotrexate on days 1-56.
- Second DI therapy: Patients receive DI/a and D1/b (without methotrexate) as in standard-risk DI. Patients also receive TIT on days 31 and 38.
- Maintenance therapy: Patients are randomized to 1 of 2 treatment arms:
- Arm I (conventional): Patients receive mercaptopurine, methotrexate, dexamethasone, and vincristine as in standard-risk maintenance therapy arm I. Patients also receive TIT on day 50. Treatment repeats every 8 weeks for up to 8 courses for girls or 11 courses for boys.
- Arm II (intervention): Patients receive treatment as in standard-risk maintenance therapy arm II.
- Patients with high-risk disease:
- Induction therapy: Patients receive treatment as in intermediate-risk induction therapy.
- First EI therapy: Patients receive treatment as in intermediate-risk first EI.
- Second EI therapy: Patients receive treatment as in intermediate-risk second EI.
- Consolidation therapy (interval between blocks is 2 weeks):
- Block 1: Patients receive dexamethasone orally or IV three times daily on days 1-5, vincristine IV on days 1 and 6, high-dose methotrexate IV over 24 hours on day 1, cyclophosphamide IV over 1 hour twice daily on days 2-4, cytarabine IV over 3 hours twice on day 5, asparaginase IV over 2 hours on days 6 and 11, and TIT on day 1.
- Block 2: Patients receive dexamethasone, high-dose methotrexate, asparaginase, and TIT as in block 1. Patients also receive vindesine IV twice daily on days 1 and 6, ifosfamide IV over 1 hour twice daily on days 2-4, and daunorubicin hydrochloride IV over 24 hours on day 5.
- Block 3: Patients receive dexamethasone and asparaginase as in block 1. Patients also receive high-dose cytarabine IV over 3 hours twice daily on days 1 and 2, etoposide IV over 1 hour five times on days 3-5, and TIT on day 5.
- Blocks 1-3 are then repeated once. Patients then proceed to delayed intensification therapy.
- Delayed intensification therapy: Patients receive dexamethasone orally or IV three times daily on days 1-7 and 15-21; doxorubicin hydrochloride IV and vincristine IV on days 8, 15, 22, and 29; and asparaginase IV on days 8, 11, 15, and 18. Patients also receive cyclophosphamide IV on day 36, cytarabine IV on days 38-41 and 45-48, thioguanine IV on days 36-49, and TIT on days 38 and 45.
- Maintenance therapy: Patients receive oral mercaptopurine and oral methotrexate once daily on days 1-14, cyclophosphamide over 1 hour and cytarabine over 1 hour once between days 15-21, oral dexamethasone two or three times daily for 5 days between days 29-35, vincristine IV on day 29, and TIT on day 22. Treatment repeats every 4 weeks. After 10 courses, patients no longer receive TIT. After 12 courses, patients no longer receive cyclophosphamide and cytarabine. At this time patients continue mercaptopurine and methotrexate on days 1-21. After 20 courses, patients no longer receive dexamethasone or vincristine. At this time, patients continue mercaptopurine and methotrexate on days 1-28. Females receive up to 17 courses and males up to 23 courses.
Some patients may also undergo radiotherapy or stem cell transplantation.
- Conditions
- Leukemia
- Being tested
- dexamethasone, mercaptopurine, methotrexate, vincristine sulfate
- Keywords
- untreated childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Given oral
mercaptopurineDrug
Given orally
methotrexateDrug
Given orally
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Standard- or Intermediate-Risk Maintenance Arm I | Active comparator | Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses. Receives: Drug: dexamethasone; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate |
| Standard- or Intermediate-Risk Maintenance Arm II | Experimental | Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses. Receives: Drug: dexamethasone; Drug: mercaptopurine; Drug: methotrexate; Drug: vincristine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow suppression and liver toxicity
compare marrow suppression in the two arms of maintenance treatment
Measured: 24 or 30 months of chemotherapy
Secondary outcomes (2)
overall and event-free survival
Measured: 3 years after stop treatment
Hospitalization rate during maintenance treatment
Measured: 24 or 30 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study start1 May 2008
- Primary completion1 Oct 2018
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Kong Li, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Chi-Kong Li, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707083
- Sponsor's protocol ID
- POWH-CRE-2008.077-T
- Other IDs
- CDR0000595184
- Status last verified
- Mar 2020
- First submitted
- 27 Jun 2008
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liu X, Zou Y, Chen X, Wang S, Guo Y, Yang W, Zhang L, Chen Y, Zhang Y, Zhu X. Minimal residual disease surveillance at day 90 predicts long-term survival in pediatric patients with T-cell acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Dec;61(14):3460-3467. doi: 10.1080/10428194.2020.1805739. Epub 2020 Aug 11.
PubMed 32779947
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
- ClinicalTrials.gov ID
- NCT00707083
- Acronym / sponsor ID
- POWH-CRE-2008.077-T
- Conditions
- Leukemia
- Keywords
- untreated childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,231 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 May 2008 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Jun 2008 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
Primary
- Compare the incidence of marrow suppression with 2 methods of maintenance treatment in children with acute lymphoblastic leukemia.
- Compare the incidence of liver toxicity with 2 methods of maintenance treatment in these patients.
Secondary
- Determine any difference in infection rates and related hospitalizations in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs intermediate vs standard), age in years (0 to 5 vs 6 to 9 vs 10 to 17), and sex.
- Patients with standard-risk disease:
- Induction therapy: Patients receive prednisolone IV or orally three times daily on days 1-7; oral dexamethasone three times daily on days 8-28; asparaginase IV over 1 hour or intramuscularly once on days 8, 11, 14, 17, 20, 23, 26, and 29; vincristine IV once on days 8, 15, 22, and 29; daunorubicin hydrochloride IV over 1 hour on days 8 and 15; and methotrexate intrathecally (IT) once on days 1, 15, and 33.
- Early intensification (EI) therapy: Patients receive cyclophosphamide IV over 1 hour on day 36, cytarabine IV continuously on days 38-41 and 45-48, oral mercaptopurine once daily on days 36-50, and methotrexate IT on days 38 and 45.
- Consolidation therapy: Two weeks after completing EI therapy, patients receive oral mercaptopurine once daily on days 1-56 and methotrexate IV over 24 hours and IT on days 8, 22, 36, and 50.
- Delayed intensification (DI) therapy:
- DI/a: Patients receive dexamethasone orally or IV three times daily on days 1-7 and 15-21, doxorubicin hydrochloride IV over 1 hour on days 1, 8, and 15; vincristine IV on days 1, 8, and 15; and asparaginase subcutaneously (SC) or IV over 1 hour on days 1, 4, 8, and 11.
- DI/b: Patients receive cyclophosphamide IV over 1 hour on day 29, cytarabine IV continuously on days 31-34 and 38-41, oral thioguanine once daily on days 29-42, and methotrexate IT on days 31 and 38.
- Maintenance therapy: Patients are randomized to one of two treatment arms. Patients who do not consent for randomization receive conventional therapy (arm I).
- Arm I (conventional): Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 courses for girls or 11 courses for boys.
- Arm II (intervention): Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
- Patients with intermediate-risk disease:
- Induction therapy: Patients receive prednisolone, dexamethasone, and asparaginase as in standard-risk induction therapy. Patients also receive vincristine IV and daunorubicin hydrochloride IV over 1 hour on days 8, 15, 22, and 29; methotrexate IT on day 1; and triple intrathecal therapy (TIT; high-dose methotrexate, cytarabine, hydrocortisone sodium succinate) on days 15 and 33.
- First EI therapy: Patients receive cyclophosphamide, cytarabine, and mercaptopurine as in standard-risk EI. Patients also receive TIT on day 38.
- Second EI therapy: Beginning 2 weeks after completing first EI, patients receive cyclophosphamide over 1 hour on day 1, oral mercaptopurine on days 1-14, cytarabine IV on days 3-6 and 10-13, and TIT on day 3.
- Consolidation therapy: Beginning 2 weeks after completing second EI, patients receive mercaptopurine as in standard-risk consolidation therapy. Patients also receive methotrexate IV over 24 hours and TIT on days 8, 22, 36, and 50.
- First DI therapy: Patients receive treatment as in standard-risk DI.
- Interim maintenance therapy: Patients receive oral mercaptopurine and oral methotrexate on days 1-56.
- Second DI therapy: Patients receive DI/a and D1/b (without methotrexate) as in standard-risk DI. Patients also receive TIT on days 31 and 38.
- Maintenance therapy: Patients are randomized to 1 of 2 treatment arms:
- Arm I (conventional): Patients receive mercaptopurine, methotrexate, dexamethasone, and vincristine as in standard-risk maintenance therapy arm I. Patients also receive TIT on day 50. Treatment repeats every 8 weeks for up to 8 courses for girls or 11 courses for boys.
- Arm II (intervention): Patients receive treatment as in standard-risk maintenance therapy arm II.
- Patients with high-risk disease:
- Induction therapy: Patients receive treatment as in intermediate-risk induction therapy.
- First EI therapy: Patients receive treatment as in intermediate-risk first EI.
- Second EI therapy: Patients receive treatment as in intermediate-risk second EI.
- Consolidation therapy (interval between blocks is 2 weeks):
- Block 1: Patients receive dexamethasone orally or IV three times daily on days 1-5, vincristine IV on days 1 and 6, high-dose methotrexate IV over 24 hours on day 1, cyclophosphamide IV over 1 hour twice daily on days 2-4, cytarabine IV over 3 hours twice on day 5, asparaginase IV over 2 hours on days 6 and 11, and TIT on day 1.
- Block 2: Patients receive dexamethasone, high-dose methotrexate, asparaginase, and TIT as in block 1. Patients also receive vindesine IV twice daily on days 1 and 6, ifosfamide IV over 1 hour twice daily on days 2-4, and daunorubicin hydrochloride IV over 24 hours on day 5.
- Block 3: Patients receive dexamethasone and asparaginase as in block 1. Patients also receive high-dose cytarabine IV over 3 hours twice daily on days 1 and 2, etoposide IV over 1 hour five times on days 3-5, and TIT on day 5.
- Blocks 1-3 are then repeated once. Patients then proceed to delayed intensification therapy.
- Delayed intensification therapy: Patients receive dexamethasone orally or IV three times daily on days 1-7 and 15-21; doxorubicin hydrochloride IV and vincristine IV on days 8, 15, 22, and 29; and asparaginase IV on days 8, 11, 15, and 18. Patients also receive cyclophosphamide IV on day 36, cytarabine IV on days 38-41 and 45-48, thioguanine IV on days 36-49, and TIT on days 38 and 45.
- Maintenance therapy: Patients receive oral mercaptopurine and oral methotrexate once daily on days 1-14, cyclophosphamide over 1 hour and cytarabine over 1 hour once between days 15-21, oral dexamethasone two or three times daily for 5 days between days 29-35, vincristine IV on day 29, and TIT on day 22. Treatment repeats every 4 weeks. After 10 courses, patients no longer receive TIT. After 12 courses, patients no longer receive cyclophosphamide and cytarabine. At this time patients continue mercaptopurine and methotrexate on days 1-21. After 20 courses, patients no longer receive dexamethasone or vincristine. At this time, patients continue mercaptopurine and methotrexate on days 1-28. Females receive up to 17 courses and males up to 23 courses.
Some patients may also undergo radiotherapy or stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard- or Intermediate-Risk Maintenance Arm I | Active comparator | Drug: dexamethasone, Drug: mercaptopurine, Drug: methotrexate, Drug: vincristine sulfatePatients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses. |
| Standard- or Intermediate-Risk Maintenance Arm II | Experimental | Drug: dexamethasone, Drug: mercaptopurine, Drug: methotrexate, Drug: vincristine sulfatePatients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| dexamethasoneGiven oral | Drug | Standard- or Intermediate-Risk Maintenance Arm I, Standard- or Intermediate-Risk Maintenance Arm II |
| mercaptopurineGiven orally | Drug | Standard- or Intermediate-Risk Maintenance Arm I, Standard- or Intermediate-Risk Maintenance Arm II |
| methotrexateGiven orally | Drug | Standard- or Intermediate-Risk Maintenance Arm I, Standard- or Intermediate-Risk Maintenance Arm II |
| vincristine sulfateGiven IV | Drug | Standard- or Intermediate-Risk Maintenance Arm I, Standard- or Intermediate-Risk Maintenance Arm II |
Primary outcome
Bone marrow suppression and liver toxicity
Time frame: 24 or 30 months of chemotherapy
compare marrow suppression in the two arms of maintenance treatment
2 secondary outcomes
overall and event-free survival
Time frame: 3 years after stop treatment
Hospitalization rate during maintenance treatment
Time frame: 24 or 30 months after chemotherapy
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 5 Mar 2020.
- Derived from this study: PubMed 32779947Liu X, Zou Y, Chen X, Wang S, Guo Y, Yang W, Zhang L, Chen Y, Zhang Y, Zhu X. Minimal residual disease surveillance at day 90 predicts long-term survival in pediatric patients with T-cell acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Dec;61(14):3460-3467. doi: 10.1080/10428194.2020.1805739. Epub 2020 Aug 11.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Chi-Kong Li, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone, mercaptopurine and methotrexate in people with Leukemia, run by Prince of Wales Hospital, Shatin, Hong Kong at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone marrow suppression and liver toxicity (time frame: 24 or 30 months of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707083, which also lists 1 linked publication.
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 5 Mar 2020.