NCT00275431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2005

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

3.1 years

First QC Date

January 10, 2006

Last Update Submit

June 24, 2011

Conditions

Follicular LymphomaDiffuse Large Cell LymphomaMantle Cell LymphomaSmall Lymphocytic LymphomaChronic Lymphocytic Leukemia

Keywords

cancerAT-101AT101B-cell malignanciesNon-Hodgkinlymphomalukemia

Outcome Measures

Primary Outcomes (1)

  • Complete or partial remission of disease.

    every 6 weeks

Secondary Outcomes (2)

  • Number of participants with adverse events.

    every 3 weeks

  • duration of response

    every 6 weeks

Interventions

AT-101DRUG

Oral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Hilton Head Island, South Carolina, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellNeoplasmsLymphoma

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lance Leopold, MD

    Ascenta Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

November 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

US(11)