Status:
TERMINATED
Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ch...
Detailed Description
OBJECTIVES: I. Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and dexamethasone (MOAB)...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00262925
Start Date
June 1 2006
End Date
February 1 2013
Last Update
May 5 2015
Active Locations (58)
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1
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
2
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
3
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
4
Edward H Kaplan MD and Associates
Skokie, Illinois, United States, 60076