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
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Diffuse Large Cell Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia
Drug: AT-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • Complete or partial remission of disease. [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AT-101
    Oral
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275431

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
San Diego, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
High Point, North Carolina, United States
United States, South Carolina
Hilton Head Island, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Vermont
Burlington, Vermont, United States
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Lance Leopold, Ascenta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00275431     History of Changes
Other Study ID Numbers: AT-101-CS-005
Study First Received: January 10, 2006
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
cancer
AT-101
AT101
B-cell malignancies
Non-Hodgkin
lymphoma
lukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Gossypol
Gossypol acetic acid
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antispermatogenic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Spermatocidal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014