Alemtuzumab With or Without Methotrexate and Mercaptopurine in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy 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; Immunoglobulins; Mercaptopurine; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of acute lymphoblastic leukemia (ALL)

• Meets 1 of the following criteria:

• Second or subsequent bone marrow relapse

• Failed ≥ 2 regimens for remission induction

• Patients who relapse while receiving standard ALL maintenance chemotherapy do not require a waiting period prior to study entry

• More than 25% blasts in bone marrow aspirate (M3 marrow)

• CD52 expression on ≥ 25% of malignant cells at relapse

• Philadelphia chromosome-positive patients must have failed prior imatinib mesylate

• Performance status - Karnofsky 50-100% (for patients > 10 years of age)

• Performance status - Lansky 50-100% (for patients ≤ 10 years of age)

• At least 8 weeks

• ALT ≤ 5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min

• Creatinine normal for age

• Pulse oximetry > 94%

• No evidence of dyspnea at rest

• No exercise intolerance

• No serious uncontrolled infection

• No autoimmune hemolytic anemia

• No autoimmune thrombocytopenia

• Not pregnant or nursing

• No nursing for 3 months after study participation

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study participation

• Seizure disorder allowed provided patients are on anticonvulsants and symptoms are well controlled

• CNS toxicity ≤ grade 2

• No other serious uncontrolled medical condition (e.g., diabetes)

• Recovered from prior immunotherapy

• At least 8 weeks since prior biologic agents (e.g., monoclonal antibodies)

• More than 1 week since prior growth factor(s)

• At least 4 months since prior stem cell transplantation

• No evidence of active acute or chronic graft-versus-host disease post allogeneic stem cell transplantation

• No prior alemtuzumab or its components

• No other concurrent anticancer immunomodulating agents

• Recovered from prior chemotherapy

• One dose of prior intrathecal (IT) methotrexate, cytarabine, and hydrocortisone; IT cytarabine alone; or IT methotrexate alone allowed as part of initial diagnostic spinal tap

• Prior hydroxyurea therapy allowed

• No other concurrent anticancer chemotherapy agents

• Prior steroid therapy allowed

• More than 2 weeks since prior radiotherapy and recovered