Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. 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. 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. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Alemtuzumab; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Immunoglobulins; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Vincristine

Criteria

Inclusion Criteria:

• Refractory or relapsed acute lymphoblastic leukemia

• Must be in first relapse or have failed to achieve complete remission with 1 prior regimen

• Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is normal

• ECOG Performance status of 0-3

• Bilirubin normal

• Creatinine normal

• Human immunodeficiency virus (HIV) negative

• Negative pregnancy test

• Fertile patients must use effective contraception

Exclusion criteria:

• Hepatitis B positivity

• Bacterial or fungal infection

• Infection requiring treatment with antibiotics

• Active cytomegalovirus infection by molecular detection methods

• Known hypersensitivity to alemtuzumab or its components

• Pregnant or nursing

• Other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma