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

NCT ID: NCT00440388

Last Updated: 2010-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-11-30

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.

Detailed Description

Further Study Details provided by Ascenta.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AT-101

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

Intervention Type: DRUG

Rituximab

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascenta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Ascenta Therapeutics

Principal Investigators

Lance Leopold, MD

Role: STUDY_DIRECTOR

Ascenta Therapeutics, Inc.

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Hematology Oncology Associates

Phoenix, Arizona, United States

Rocky Mountain Cancer Center-Aurora

Aurora, Colorado, United States

Florida Cancer Institute

Hudson, Florida, United States

Florida Cancer Institute

New Port Richey, Florida, United States

Cancer Care & Hematology Specialists of Chicagoland

Arlington Heights, Illinois, United States

Central Indiana Cancer Centers

Fishers, Indiana, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Hematology/Oncology Associates

Albuquerque, New Mexico, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Northwest Cancer Specialists

Portland, Oregon, United States

The Jones Clinic

Germantown, Tennessee, United States

Texas Oncology, P.A.

Bedford, Texas, United States

Texas Cancer Center at Medical City

Dallas, Texas, United States

Texas Oncology, P.A.

Fort Worth, Texas, United States

Allison Cancer Center

Midland, Texas, United States

HOAST - New Braunfels

New Braunfels, Texas, United States

West Texas Cancer Center

Odessa, Texas, United States

Hematology Oncology Physicians of Texas

Richardson, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Virginia Oncology Associates

Chesapeake, Virginia, United States

Oncology and Hematology Associates of SW Virginia, Inc.

Salem, Virginia, United States

Cancer Care Northwest

Spokane, Washington, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

AT-101-CS-203

Identifier Type: -

Identifier Source: org_study_id