Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascenta Therapeutics
• Treatments: Gossypol; Gossypol acetic acid; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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