Status:
COMPLETED
Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Follicular Lymphoma
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00275431
Start Date
November 1 2005
End Date
December 1 2008
Last Update
June 29 2011
Active Locations (11)
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1
Birmingham, Alabama, United States
2
San Diego, California, United States
3
Atlanta, Georgia, United States
4
Chicago, Illinois, United States