Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies

NCT ID: NCT00275431

Last Updated: 2011-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-12-31

Brief Summary

This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.

Detailed Description

This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies. For the purpose of this study, B-cell malignancies can include one of the following disease sub-types: follicular lymphoma (FL), diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia. Patients will be enrolled according to disease subtype into one of four groups in two stages. The first stage of each group will enrolled 13 patients. If patients within any group experience disease response, an additional 14 patients will be enrolled into that group.

Conditions

Follicular Lymphoma; Diffuse Large Cell Lymphoma; Mantle Cell Lymphoma; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Study Design

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

Interventions

AT-101

Oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have a histologically confirmed B-cell malignancy (defined as FL [any grade], DLBCL, MCL or SLL/CLL);
• Male or non-pregnant, non-lactating females age ≥18 years;
• Ability to swallow and retain oral medication.;
• Have failed at least one prior therapy and have documentation of either, relapsed disease, or refractory disease (i.e., no response or stable disease on their last regimen of therapy);
• ECOG performance status 0 or 1;
• All clinically significant toxicities from prior therapy must have fully resolved;
• Must have discontinued treatment with monoclonal antibodies for a minimum of 90 days prior to first dose of AT-101, or have objective documentation of disease progression if within 90 days of monoclonal antibody administration;
• Patients with FL, DLBCL, MCL, and SLL with normal lymphocyte counts must have at least one bi-dimensional lesion that is radiographically measurable (skin lesions, palpable lymph nodes, and bone marrow as the only site of disease are not considered measurable disease);
• Patients with SLL whose lymphocytes are elevated at baseline or CLL must have palpable lymph nodes and/or disease localized to the bone marrow per the NCI-Sponsored Working Group Guidelines for CLL.

Exclusion Criteria

• Requirement of systemic corticosteroids within 7 days prior to and during AT-101 administration;
• Must not have received anti-cancer therapy within 28 days of first dose of AT-101. Cannot have received hormonal agents or biologic dose modifiers (with the exception of HRT) or any investigational treatments within 28 days of treatment with AT-101;
• Patients with CNS lymphoma, HIV-related lymphoma, symptoms suggesting HIV infection or active auto-immune hemolytic anemia are excluded;
• Previous treatment with gossypol, or are hypersensitive to its excipient are excluded;
• Patients who have an uncontrolled, concurrent illness are also excluded.

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

Sponsors

Ascenta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Ascenta Therapeutics, Inc.

Principal Investigators

Lance Leopold, MD

Role: STUDY_DIRECTOR

Ascenta Therapeutics, Inc.

Locations

Birmingham, Alabama, United States

San Diego, California, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

New York, New York, United States

Rochester, New York, United States

High Point, North Carolina, United States

Hilton Head Island, South Carolina, United States

Memphis, Tennessee, United States

Burlington, Vermont, United States

Countries

United States

Other Identifiers

AT-101-CS-005

Identifier Type: -

Identifier Source: org_study_id