NCT00440388

Brief Summary

This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

28 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

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

August 27, 2010

Status Verified

August 1, 2010

Enrollment Period

2.1 years

First QC Date

February 23, 2007

Last Update Submit

August 24, 2010

Conditions

Follicular Lymphoma

Keywords

cancerlymphomaNon-Hodgkin'sNon-HodgkinsAT-101AT101RituxanRituximab

Outcome Measures

Primary Outcomes (1)

  • complete or partial remission of disease

    8 weeks

Secondary Outcomes (2)

  • duration of complete or partial remission of disease

    10 months

  • number of participants with adverse events

    10 months

Interventions

AT-101DRUG

AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.

RituximabDRUG

Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed, previously untreated Grade I-II follicular B-cell non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received radiation therapy to one lymph node region; Stage I or II patients must have relapsed after prior radiation therapy to be eligible;
  • Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of worsening disease;
  • ECOG performance status 0-1;
  • Measurable disease;
  • Adequate hematological function as indicated by:
  • Absolute neutrophil count (ANC) \>1,000/µL; +Hemoglobin \>8 g/dL (It is acceptable to transfuse PRBC to achieve this criterion);
  • Platelet count \>50 x 109/L.
  • Adequate hepatic and renal function as indicated by:
  • Serum creatinine ≤2.0 mg/dL;
  • Serum albumin ≥2.5 g/dL;
  • Total bilirubin ≤1.5 x upper limit of normal (ULN);
  • Serum AST and ALT ≤1.5 x ULN.
  • Able to swallow and retain oral medication

You may not qualify if:

  • Patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
  • Active symptomatic fungal, bacterial and/or viral infection including, but not limited to active HIV or viral hepatitis (A, B or C);
  • History of hepatitis B infection;
  • Any B-cell, T-cell or transformed lymphoma other than histologically confirmed follicular non-Hodgkin's lymphoma;
  • Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma (treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting HIV infection;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

University of Alabama at Birmingham

Birmingham, Alabama, 35296, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, United States

Location

Rocky Mountain Cancer Center-Aurora

Aurora, Colorado, United States

Location

Florida Cancer Institute

Hudson, Florida, 34667, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34655, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Arlington Heights, Illinois, United States

Location

Central Indiana Cancer Centers

Fishers, Indiana, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Location

Missouri Cancer Associates

Columbia, Missouri, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Location

Hematology/Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

Northwest Cancer Specialists

Portland, Oregon, United States

Location

The Jones Clinic

Germantown, Tennessee, 38138, United States

Location

Texas Oncology, P.A.

Bedford, Texas, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, United States

Location

Allison Cancer Center

Midland, Texas, United States

Location

HOAST - New Braunfels

New Braunfels, Texas, United States

Location

West Texas Cancer Center

Odessa, Texas, United States

Location

Hematology Oncology Physicians of Texas

Richardson, Texas, 75080, United States

Location

Tyler Cancer Center

Tyler, Texas, United States

Location

Virginia Oncology Associates

Chesapeake, Virginia, United States

Location

Oncology and Hematology Associates of SW Virginia, Inc.

Salem, Virginia, 24153, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularNeoplasmsLymphoma

Interventions

gossypol acetic acidRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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

February 23, 2007

First Posted

February 27, 2007

Study Start

October 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

August 27, 2010

Record last verified: 2010-08

Locations

US(28)