Status:
COMPLETED
Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.
Eligibility Criteria
Inclusion
- Diagnosis of CLL as defined by the NCI-working group
- Previous treatment with standard systemic chemotherapy or immunotherapy.
- Disease progression or relapse after treatment.
- Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
- ECOG performance status ≤ 2
- Adequate liver and renal and bone marrow function
Exclusion
- Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
- Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
- Active secondary malignancy or history of other malignancy within the last five years
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
- Patients who are contraindicated for treatment with rituximab
- Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
- T-CLL or other T-cell malignancy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00286780
Start Date
January 1 2006
End Date
November 1 2007
Last Update
August 13 2010
Active Locations (1)
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1
UCSD Moores Cancer Center
San Diego, California, United States, 92093