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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00286780

Enrollment

Registered

2006-02-06

Start date

2006-01-31

Completion date

2007-11-30

Last updated

2010-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

AT101, AT-101, cancer, lymphoctic, lukemia, Rituximab

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.

Interventions

DRUGAT-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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Preliminary efficacy of AT-101 in combination with rituximab	5 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026