Overview

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
6-Mercaptopurine
Acyclovir
Alemtuzumab
Allopurinol
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Imatinib Mesylate
Leucovorin
Levoleucovorin
Mercaptopurine
Methotrexate
Sulfamethoxazole
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Vincristine
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