Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma

August 24, 2010 updated by: Ascenta Therapeutics

An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further Study Details provided by Ascenta.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35296
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States
        • Hematology Oncology Associates
    • Colorado
      • Aurora, Colorado, United States
        • Rocky Mountain Cancer Center-Aurora
    • Florida
      • Hudson, Florida, United States, 34667
        • Florida Cancer Institute
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Institute
    • Illinois
      • Arlington Heights, Illinois, United States
        • Cancer Care & Hematology Specialists of Chicagoland
    • Indiana
      • Fishers, Indiana, United States
        • Central Indiana Cancer Centers
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, United States
        • Missouri Cancer Associates
    • Nevada
      • Henderson, Nevada, United States
        • Comprehensive Cancer Centers of Nevada
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Hematology/Oncology Associates
    • New York
      • Albany, New York, United States
        • New York Oncology Hematology, P.C.
    • North Carolina
      • Durham, North Carolina, United States, 27707
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States
        • Northwest Cancer Specialists
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
    • Texas
      • Bedford, Texas, United States
        • Texas Oncology, P.A.
      • Dallas, Texas, United States
        • Texas Cancer Center at Medical City
      • Fort Worth, Texas, United States
        • Texas Oncology, P.A.
      • Midland, Texas, United States
        • Allison Cancer Center
      • New Braunfels, Texas, United States
        • HOAST - New Braunfels
      • Odessa, Texas, United States
        • West Texas Cancer Center
      • Richardson, Texas, United States, 75080
        • Hematology Oncology Physicians of Texas
      • Tyler, Texas, United States
        • Tyler Cancer Center
    • Virginia
      • Chesapeake, Virginia, United States
        • Virginia Oncology Associates
      • Salem, Virginia, United States, 24153
        • Oncology and Hematology Associates of SW Virginia, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete or partial remission of disease
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of complete or partial remission of disease
Time Frame: 10 months
10 months
number of participants with adverse events
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascenta Therapeutics

Investigators

  • Study Director: Lance Leopold, MD, Ascenta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-101-CS-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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