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

Sponsor

Ascenta Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00286780

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: AT-101	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: 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

Arm

Intervention/Treatment

Experimental: 1

Drug: 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

Outcome Measures

Primary Outcome Measures

Safety of AT-101 in combination with rituximab [5 months for each patient; 20 months entire study]

Secondary Outcome Measures

Preliminary efficacy of AT-101 in combination with rituximab [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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