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

Ascenta Therapeutics

Status and phase

Completed

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: AT-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00286780

AT-101-CS-008

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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