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

Completed · Phase 2

Conditions studied: Recurrent Childhood Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT00089349

Run by

National Cancer Institute (NCI)

People needed

25

Starts

2004-07-01

Last updated by the study team

2013-06-05

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• COG Phase I Consortium — Arcadia, California, United States

Full record on ClinicalTrials.gov

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