Status:
TERMINATED
Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
Cephalon
Conditions:
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of alemtuzumab when given together with bendamustine hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL) o...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the safety of the combination of alemtuzumab and bendamustine (bendamustine hydrochloride) in patients with advanced CLL. II. Establish the maximum tolerated dose of ...
Eligibility Criteria
Inclusion
- Patients with CLL or SLL as defined by the WHO classification system with indications for treatment by National Cancer Institute (NCI) Working Group criteria.
- Measurable disease (lymphocytes equal or greater than 5,000/µL, or measurable lymphadenopathy, or bone marrow involvement greater than 30%).
- Males and females 18 years of age or older.
- Patients must be relapsed or refractory and have been treated with a minimum of one prior purine analog-based chemotherapy regimen (e.g., fludarabine, cladribine, or pentostatin).
- All previous cancer therapies, radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to the start of treatment. Any cytotoxic chemotherapy must have been discontinued 28 days prior to the start of treatment. Acute toxicities from prior therapy must have resolved to Grade ≤ 1 above baseline.
- Normal oxygen saturation with pulse oximetry on room air.
- Hemoglobin 9 or greater gm/dL (may be post-transfusion).
- Platelet count 50 x103/mL or greater
- Total bilirubin less than 2 X ULN, and ALT and AST less than 2 x ULN.
- Serum creatinine 2 X ULN or less. In addition, the calculated glomerular filtration rate (GFR) must be \> 30cc/min.
- ECOG Performance Status 2 or less.
- Anticipated survival of at least 3 months.
- For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after discontinuation of treatment.
Exclusion
- Pregnant or lactating women.
- Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
- Seizures not controlled by anticonvulsant therapy.
- Participation in any investigational drug study within 28 days before study entry.
- Patients with second malignancy requiring active treatment.
- Active, symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
- Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
- Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
- Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any of the study's endpoints.
- Systemic treatment for CLL/SLL within 28 days of study entry
- Subjects with a history of leukemic meningitis, or signs and symptoms suggestive of leukemic meningitis, must have a negative lumbar puncture within 2 weeks of study entry.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00947388
Start Date
November 1 2008
End Date
March 1 2013
Last Update
August 22 2013
Active Locations (2)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195