Phase 2
N=54
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00038610 ↗Enrolled (actual)
54
Serious AEs
66.7%
Results posted
Sep 2015
Primary outcome: Primary: Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate — 42; 1; 17; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Imatinib Mesylate (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Dexamethasone (Drug); Methotrexate (Drug); Cytarabine (Drug); Mesna (Drug); G-CSF (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate |
42; 1; 17; 1 | — |
| PRIMARY Disease-Free Survival Rate at 2-year and 5-year. |
49; 43 | — |
| SECONDARY Overall Survival Rate at 2-year and 5-year. |
57; 43 | — |
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 acute lymphoblastic leukemia. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00038610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.