Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00947388
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2008-11-30
2013-03-31
Brief Summary
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Detailed Description
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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 alemtuzumab up to the standard dose of 30mg thrice weekly when combined with bendamustine at a standard dose of 70 mg/m\^2 day 8 and 9 monthly.
III. Define a recommended dose for subsequent Phase II studies. IV. Evaluate preliminary evidence of activity as determined by response rates with correlation to EAS flow cytometry.
OUTLINE: This is a dose-escalation study of alemtuzumab.
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 8 and 9 for up to 6 courses in the absence of disease progression or unacceptable toxicity and alemtuzumab subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
After completion of study treatment, patients are followed every 3 months for 1 year.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine plus Alemtuzumab
Bendamustine Hydrochloride
Bendamustine 70 mg/m2 IV Day 8 and 9 every 28 days for 6 courses of therapy
Alemtuzumab
Given subcutaneously (SC)on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
Interventions
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Bendamustine Hydrochloride
Bendamustine 70 mg/m2 IV Day 8 and 9 every 28 days for 6 courses of therapy
Alemtuzumab
Given subcutaneously (SC)on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Measurable disease (lymphocytes equal or greater than 5,000/µL, or measurable lymphadenopathy, or bone marrow involvement greater than 30%).
3. Males and females 18 years of age or older.
4. 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).
5. 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.
6. Normal oxygen saturation with pulse oximetry on room air.
7. Hemoglobin 9 or greater gm/dL (may be post-transfusion).
8. Platelet count 50 x103/mL or greater
9. Total bilirubin less than 2 X ULN, and ALT and AST less than 2 x ULN.
10. Serum creatinine 2 X ULN or less. In addition, the calculated glomerular filtration rate (GFR) must be \> 30cc/min.
11. ECOG Performance Status 2 or less.
12. Anticipated survival of at least 3 months.
13. 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 Criteria
2. Severe chronic obstructive pulmonary disease with hypoxemia or an uncorrectable pulmonary compromise.
3. Seizures not controlled by anticonvulsant therapy.
4. Participation in any investigational drug study within 28 days before study entry.
5. Patients with second malignancy requiring active treatment.
6. Active, symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis.
7. 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.
8. Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction).
9. 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.
10. Systemic treatment for CLL/SLL within 28 days of study entry
11. 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.
18 Years
ALL
Yes
Sponsors
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Cephalon
INDUSTRY
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Matt Kalaycio, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Paolo Caimi, MD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2010-00272
Identifier Type: OTHER
Identifier Source: secondary_id
CASE1907
Identifier Type: -
Identifier Source: org_study_id