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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma, Diffuse Large Cell Lymphoma, Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

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. 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete or partial remission of disease.

Outcome Time Frame:

every 6 weeks

Safety Issue:

No

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-005

NCT ID:

NCT00275431

Start Date:

November 2005

Completion Date:

December 2008

Related Keywords:

  • Follicular Lymphoma
  • Diffuse Large Cell Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • cancer
  • AT-101
  • AT101
  • B-cell malignancies
  • Non-Hodgkin
  • lymphoma
  • lukemia
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Albany, New York  12208
Nashville, Tennessee  37203-1632
Boston, Massachusetts  
Charlotte, North Carolina  
South Burlington, Vermont  
Charleston, South Carolina