A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia

Ascenta Therapeutics1 site in 1 country19 target enrollmentJanuary 2006

ConditionsChronic Lymphocytic Leukemia

InterventionsAT-101

DrugsAT-101

Overview

Phase: Phase 2
Intervention: AT-101
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Ascenta Therapeutics
Enrollment: 19
Locations: 1
Primary Endpoint: Safety of AT-101 in combination with rituximab
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

November 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ascenta Therapeutics

Eligibility 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 ≤
•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