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

NCT ID: NCT00286780

Last Updated: 2010-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-11-30

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

AT-101

Intervention Type: DRUG

80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks

Interventions

AT-101

80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks

Intervention Type: DRUG

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 ≤ 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascenta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Ascenta Therapeutics

Principal Investigators

Thomas Kipps, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Moores Cancer Center

San Diego, California, United States

Countries

United States

Other Identifiers

AT-101-CS-008

Identifier Type: -

Identifier Source: org_study_id