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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: AT-101

• Registration Number: NCT00286780
• Lead Sponsor: Ascenta Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-12
• Last Update Posted: 2010-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AT-101	-

Primary Outcome Measures

Name	Time	Method
Safety of AT-101 in combination with rituximab	5 months for each patient; 20 months entire study

Secondary Outcome Measures

Name	Time	Method
Preliminary efficacy of AT-101 in combination with rituximab	5 months

Trial Locations

Locations (1)

UCSD Moores Cancer Center; 🇺🇸 San Diego, California, United States