Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia
Completed · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT00286780
- Run by
- Ascenta Therapeutics
- People needed
- 19
- Starts
- 2006-01-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2010-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCSD Moores Cancer Center — San Diego, California, United States
Full record on ClinicalTrials.gov
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