LeukemiaPhase 2NCT00038610
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
A Phase 2 study testing Imatinib Mesylate, Cyclophosphamide and Doxorubicin in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Imatinib Mesylate, Cyclophosphamide and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
- Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
- Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
- Adequate cardiac function as assessed clinically by physical examination.
- Signed informed consent.
Who cannot join
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
- Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
- History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Prior history of treatment with imatinib mesylate.
- Pregnancy or lactating in women of childbearing potential.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Read the detailed description
Before treatment starts, patients will have a complete exam, including medical history and documentation of disease, blood, and marrow tests. A chest x-ray will be taken. CT scans may be taken if needed. A bone marrow sample will be taken through a large needle. An EKG and MUGA (heart function tests) will be performed.
During treatment, patients will give blood samples (about 1 tablespoon each) at least twice a week. A bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check on response. After two courses of chemotherapy, the tests done before treatment will be repeated to check for response.
All patients will receive 2 kinds of chemotherapy courses for a total of 8 courses. Chemotherapy courses will be given through a large vein by a central venous catheter (a plastic tube usually placed under the collarbone). Imatinib mesylate will be given as a pill with the chemotherapy.
Course 1 will start with cyclophosphamide given by vein over 2-3 hours every 12 hours for 6 doses over 3 days (Days 1,2,3). Mesna will be given by vein continuously for 4 days with the cyclophosphamide to protect the bladder. Doxorubicin will be given by vein over 24 hours on Day 4. Vincristine will be given by short infusion on Days 4 and 11. Dexamethasone (a steroid) will be given by mouth or by vein on Days 1-4 and 11-14. The imatinib mesylate will be given by mouth with breakfast and a large glass of water daily on Days 1-14. Medicines will be given to prevent nausea and to protect the kidneys from increased amounts of uric acid, which may be released when leukemia cells die.
G-CSF (growth stimulating colony factor) will be given after completion of the chemotherapy. It is given to allow for rapid recovery of the normal marrow. G-CSF will be injected under the skin until the counts recover. Treatment to the brain will be given inside the spinal fluid with methotrexate around Day 2 and cytarabine about day 7. This is done to prevent the leukemia from developing there.
For patients aged 60 years or older, this Course 1 will be given in a protective isolation room to decrease the risk of infection(s).
During Course 2, patients will be given methotrexate by infusion over 24 hours on the first day and cytarabine at a high dose over 2 hours every 12 hours for 4 doses (Days 2 and 3). Citrovorum factor (leucovorin), an antidote for side effects of methotrexate, will be given by vein or by mouth for 2-3 days (Day 2 and on). Solumedrol (a steroid) will be given by vein every 12 hours for 6 doses. Imatinib mesylate will be given by mouth with breakfast and a large glass of water on Days 1-14 or daily, depending on tolerance with Course 1. G-CSF will be given as in Course 1. The treatment to the brain inside the spinal fluid will be given as in Course 1 around Days 2 and 7.
The chemotherapy will alternate between hyper-CVAD plus imatinib mesylate (Courses 1, 3, 5, and 7) and methotrexate/cytarabine plus imatinib mesylate (Courses 2, 4, 6, and 8) to complete a total of 8 courses. G-CSF will be given as in Course 1. Anti-nausea medicine will be given with each course of chemotherapy. The urine will be alkalized to protect the kidneys. Antibiotics will be given by mouth to prevent infection.
After the 8 courses, monthly maintenance chemotherapy plus imatinib mesylate will be given. This includes daily imatinib mesylate, monthly vincristine by vein, and prednisone by mouth for 5 days every month. Maintenance chemotherapy will be given for a total of 24 months, and will be interrupted by 2 periods of intensive chemotherapy courses with hyper-CVAD and imatinib mesylate at 6 and 13 months from the start of maintenance. Imatinib mesylate will be continued daily as tolerated indefinitely.
After two courses of the intensive chemotherapy, the response to the treatment will be evaluated. If the leukemia is responding, the therapy will be continued. Patients will be taken off study if the leukemia starts to get worse.
During and after completion of treatment, patients will have a complete exam, including blood tests. If needed, a chest X-ray or CT scan will be done. A bone marrow sample will be taken through a large needle. Patients will then return every 2 to 3 months for a checkup, including blood and bone marrow. X-rays and heart studies (MUGA or ECG) may be repeated if needed.
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to prevent leukemia in patients who have difficulty with the spinal treatments. An Ommaya reservoir is an access port inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain.
Treatment will be given on an inpatient basis (3 to 5 days) for the 8 intensive courses of chemotherapy, or as indicated by the clinical condition. The maintenance treatments will be given as an outpatient, except for the courses of hyper-CVAD and imatinib mesylate.
This is an investigational study. The FDA has approved imatinib mesylate for use in chronic myelogenous leukemia and other clinical research studies. About 55 patients will take part in this study. All will be from MD Anderson.
- Conditions
- Leukemia
- Being tested
- Imatinib Mesylate, Cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone
- Keywords
- Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Imatinib Mesylate, Gleevec, Glivec, Imatinib, STI571, STI-571, CGP-57148B, NSC-716051, Cyclophosphamide, Cytoxan®,, Neosar®, Doxorubicin, Adriamycin ®, Rubex ®, Adriamycin PFS, Adriamycin RDF
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called Gleevec, Glivec, Imatinib, STI571
600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8.
CyclophosphamideDrug
Also called Cytoxan®,, Neosar®
300 mg/m^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m^2) for courses 1, 3, 5, 7.
DoxorubicinDrug
Also called Adriamycin ®, Rubex ®, Adriamycin PFS, Adriamycin RDF
50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.
VincristineDrug
2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.
DexamethasoneDrug
Also called Decadron
40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.
MethotrexateDrug
12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7.
200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours on day 1 of courses 2, 4, 6, 8.
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
100 mg intrathecally day 7 for courses 1, 3, 5, 7.
3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8.
MesnaDrug
Also called Mesnex
600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7.
G-CSFDrug
Also called Filgrastim, Neupogen
10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
| Study group | Role | What they receive |
|---|---|---|
| Hyper-CVAD + Imatinib | Experimental | Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses. Receives: Drug: Imatinib Mesylate; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Dexamethasone; Drug: Methotrexate; Drug: Cytarabine; Drug: Mesna; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.
Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.
Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
Measured: Baseline to 6 months
Disease-Free Survival Rate at 2-year and 5-year.
Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.
Measured: Baseline to 2-year and 5-year
Secondary outcomes (1)
Overall Survival Rate at 2-year and 5-year.
Overall survival (OS) was calculated from the date of initiation of therapy until death.
Measured: Baseline to 2-year and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2002 (estimated)
- Study startMar 2001
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Naval Daver, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038610
- Sponsor's protocol ID
- ID01-006
- Other IDs
- NCI-2012-01487
- Status last verified
- Aug 2015
- First submitted
- 3 Jun 2002
- Last updated
- 18 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ribera JM, Prawitz T, Freitag A, Sharma A, Dobi B, Rizzo F, Sabatelli L, Patos P. Ponatinib vs. Imatinib as Frontline Treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Matching Adjusted Indirect Comparison. Adv Ther. 2023 Jul;40(7):3087-3103. doi: 10.1007/s12325-023-02497-y. Epub 2023 May 19.
PubMed 37208556Daver N, Thomas D, Ravandi F, Cortes J, Garris R, Jabbour E, Garcia-Manero G, Borthakur G, Kadia T, Rytting M, Konopleva M, Kantarjian H, O'Brien S. Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Haematologica. 2015 May;100(5):653-61. doi: 10.3324/haematol.2014.118588. Epub 2015 Feb 14.
PubMed 25682595
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00038610
- Acronym / sponsor ID
- ID01-006
- Conditions
- Leukemia
- Keywords
- Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, Imatinib Mesylate, Gleevec, Glivec, Imatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2001
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2002 (estimated)
- Results
- Posted 18 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Detailed description
Before treatment starts, patients will have a complete exam, including medical history and documentation of disease, blood, and marrow tests. A chest x-ray will be taken. CT scans may be taken if needed. A bone marrow sample will be taken through a large needle. An EKG and MUGA (heart function tests) will be performed.
During treatment, patients will give blood samples (about 1 tablespoon each) at least twice a week. A bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check on response. After two courses of chemotherapy, the tests done before treatment will be repeated to check for response.
All patients will receive 2 kinds of chemotherapy courses for a total of 8 courses. Chemotherapy courses will be given through a large vein by a central venous catheter (a plastic tube usually placed under the collarbone). Imatinib mesylate will be given as a pill with the chemotherapy.
Course 1 will start with cyclophosphamide given by vein over 2-3 hours every 12 hours for 6 doses over 3 days (Days 1,2,3). Mesna will be given by vein continuously for 4 days with the cyclophosphamide to protect the bladder. Doxorubicin will be given by vein over 24 hours on Day 4. Vincristine will be given by short infusion on Days 4 and 11. Dexamethasone (a steroid) will be given by mouth or by vein on Days 1-4 and 11-14. The imatinib mesylate will be given by mouth with breakfast and a large glass of water daily on Days 1-14. Medicines will be given to prevent nausea and to protect the kidneys from increased amounts of uric acid, which may be released when leukemia cells die.
G-CSF (growth stimulating colony factor) will be given after completion of the chemotherapy. It is given to allow for rapid recovery of the normal marrow. G-CSF will be injected under the skin until the counts recover. Treatment to the brain will be given inside the spinal fluid with methotrexate around Day 2 and cytarabine about day 7. This is done to prevent the leukemia from developing there.
For patients aged 60 years or older, this Course 1 will be given in a protective isolation room to decrease the risk of infection(s).
During Course 2, patients will be given methotrexate by infusion over 24 hours on the first day and cytarabine at a high dose over 2 hours every 12 hours for 4 doses (Days 2 and 3). Citrovorum factor (leucovorin), an antidote for side effects of methotrexate, will be given by vein or by mouth for 2-3 days (Day 2 and on). Solumedrol (a steroid) will be given by vein every 12 hours for 6 doses. Imatinib mesylate will be given by mouth with breakfast and a large glass of water on Days 1-14 or daily, depending on tolerance with Course 1. G-CSF will be given as in Course 1. The treatment to the brain inside the spinal fluid will be given as in Course 1 around Days 2 and 7.
The chemotherapy will alternate between hyper-CVAD plus imatinib mesylate (Courses 1, 3, 5, and 7) and methotrexate/cytarabine plus imatinib mesylate (Courses 2, 4, 6, and 8) to complete a total of 8 courses. G-CSF will be given as in Course 1. Anti-nausea medicine will be given with each course of chemotherapy. The urine will be alkalized to protect the kidneys. Antibiotics will be given by mouth to prevent infection.
After the 8 courses, monthly maintenance chemotherapy plus imatinib mesylate will be given. This includes daily imatinib mesylate, monthly vincristine by vein, and prednisone by mouth for 5 days every month. Maintenance chemotherapy will be given for a total of 24 months, and will be interrupted by 2 periods of intensive chemotherapy courses with hyper-CVAD and imatinib mesylate at 6 and 13 months from the start of maintenance. Imatinib mesylate will be continued daily as tolerated indefinitely.
After two courses of the intensive chemotherapy, the response to the treatment will be evaluated. If the leukemia is responding, the therapy will be continued. Patients will be taken off study if the leukemia starts to get worse.
During and after completion of treatment, patients will have a complete exam, including blood tests. If needed, a chest X-ray or CT scan will be done. A bone marrow sample will be taken through a large needle. Patients will then return every 2 to 3 months for a checkup, including blood and bone marrow. X-rays and heart studies (MUGA or ECG) may be repeated if needed.
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to prevent leukemia in patients who have difficulty with the spinal treatments. An Ommaya reservoir is an access port inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain.
Treatment will be given on an inpatient basis (3 to 5 days) for the 8 intensive courses of chemotherapy, or as indicated by the clinical condition. The maintenance treatments will be given as an outpatient, except for the courses of hyper-CVAD and imatinib mesylate.
This is an investigational study. The FDA has approved imatinib mesylate for use in chronic myelogenous leukemia and other clinical research studies. About 55 patients will take part in this study. All will be from MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyper-CVAD + Imatinib | Experimental | Drug: Imatinib Mesylate, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Dexamethasone, Drug: Methotrexate, Drug: Cytarabine, Drug: Mesna, Drug: G-CSFImatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
- Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
- Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
- Adequate cardiac function as assessed clinically by physical examination.
Key exclusion criteria (6 listed)
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
- Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
- History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Prior history of treatment with imatinib mesylate.
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 |
|---|---|---|
| Imatinib MesylateAlso: Gleevec, Glivec, Imatinib, STI571600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8. | Drug | Hyper-CVAD + Imatinib |
| CyclophosphamideAlso: Cytoxan®,, Neosar®300 mg/m^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m^2) for courses 1, 3, 5, 7. | Drug | Hyper-CVAD + Imatinib |
| DoxorubicinAlso: Adriamycin ®, Rubex ®, Adriamycin PFS, Adriamycin RDF50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7. | Drug | Hyper-CVAD + Imatinib |
| Vincristine2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7. | Drug | Hyper-CVAD + Imatinib |
| DexamethasoneAlso: Decadron40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7. | Drug | Hyper-CVAD + Imatinib |
| Methotrexate12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7. 200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours on day 1 of courses 2, 4, 6, 8. | Drug | Hyper-CVAD + Imatinib |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride100 mg intrathecally day 7 for courses 1, 3, 5, 7. 3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8. | Drug | Hyper-CVAD + Imatinib |
| MesnaAlso: Mesnex600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7. | Drug | Hyper-CVAD + Imatinib |
| G-CSFAlso: Filgrastim, Neupogen10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses. | Drug | Hyper-CVAD + Imatinib |
Primary outcome
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Time frame: Baseline to 6 months
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease. Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts. Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl. Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
Disease-Free Survival Rate at 2-year and 5-year.
Time frame: Baseline to 2-year and 5-year
Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.
1 secondary outcome
Overall Survival Rate at 2-year and 5-year.
Time frame: Baseline to 2-year and 5-year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37208556Ribera JM, Prawitz T, Freitag A, Sharma A, Dobi B, Rizzo F, Sabatelli L, Patos P. Ponatinib vs. Imatinib as Frontline Treatment for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Matching Adjusted Indirect Comparison. Adv Ther. 2023 Jul;40(7):3087-3103. doi: 10.1007/s12325-023-02497-y. Epub 2023 May 19.
- Derived from this study: PubMed 25682595Daver N, Thomas D, Ravandi F, Cortes J, Garris R, Jabbour E, Garcia-Manero G, Borthakur G, Kadia T, Rytting M, Konopleva M, Kantarjian H, O'Brien S. Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Haematologica. 2015 May;100(5):653-61. doi: 10.3324/haematol.2014.118588. Epub 2015 Feb 14.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Naval Daver, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib Mesylate, Cyclophosphamide and Doxorubicin in people with Leukemia, run by M.D. Anderson Cancer Center 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 6 inclusion and 6 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 18 Sep 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT00038610, which also lists 2 linked publications.
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 18 Sep 2015.