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

Completed · Phase 2

Conditions studied: Follicular Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00275431

Run by

Ascenta Therapeutics

People needed

50

Starts

2005-11-01

Expected to finish

2008-12-01

Last updated by the study team

2011-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — San Diego, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — High Point, North Carolina, United States
• Study site — Hilton Head Island, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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