Phase 2
N=300
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Acute Undifferentiated Leukemia · B-cell Adult Acute Lymphoblastic Leukemia · B-cell Childhood Acute Lymphoblastic Leukemia · L1 Adult Acute Lymphoblastic Leukemia · L1 Childhood Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00061945 ↗Enrolled (actual)
300
Serious AEs
52.7%
Results posted
Apr 2014
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) — 30 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- allopurinol (Drug); cyclophosphamide (Drug); daunorubicin hydrochloride (Drug); vincristine sulfate (Drug); dexamethasone (Drug); asparaginase (Drug); filgrastim (Biological); imatinib mesylate (Drug); methotrexate (Drug); cytarabine (Drug); trimethoprim-sulfamethoxazole (Drug); mercaptopurine (Drug); leucovorin calcium (Drug); alemtuzumab (Biological); acyclovir (Drug); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) |
30 | — |
| PRIMARY Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) |
30 | — |
| SECONDARY Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II) |
16 | — |
| SECONDARY Disease-free Survival, for Only Complete Response Patients |
58.6; 19.8 | — |
| SECONDARY Overall Survival |
33.6; 23.1 | — |
Summary
This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.
Eligibility Criteria
Inclusion Criteria
- Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia (World Health Organization [WHO] classification), L1 or L2 ALL or acute undifferentiated leukemia (AUL) (French-American-British Cooperative group [FAB] Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin [SIg]+) are excluded
- No prior treatment for leukemia with three permissible exceptions:
- Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- All patients must have a pre-treatment bone marrow or peripheral blood sample submitted for central immunophenotyping; only those patients who express CD52 >= 10% in the leukemia blast cell channel will be eligible to receive Campath-1H during module D, course IV
Data sourced from ClinicalTrials.gov (NCT00061945). 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.