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

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00275431
First received: January 10, 2006
Last updated: June 24, 2011
Last verified: June 2011

January 10, 2006
June 24, 2011
November 2005
December 2008   (final data collection date for primary outcome measure)
Complete or partial remission of disease. [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00275431 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events. [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies
A Phase II, Open Label, Multicenter Study of Single-Agent AT-101 in Patients With Relapsed or Refractory B-Cell Malignancies (Follicular Lymphoma, Mantle Cell Lymphoma, Diffuse Large Cell Lymphoma, or Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Follicular Lymphoma
  • Diffuse Large Cell Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
Drug: AT-101
Oral
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275431
AT-101-CS-005
Not Provided
Lance Leopold, Ascenta Therapeutics, Inc.
Ascenta Therapeutics
Not Provided
Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
Ascenta Therapeutics
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP