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

Phase 2

Completed

Conditions: Follicular Lymphoma

Registration Number: NCT00440388

Lead Sponsor: Ascenta Therapeutics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete or partial remission of disease	8 weeks

Secondary Outcome Measures

Name	Time	Method
duration of complete or partial remission of disease	10 months
number of participants with adverse events	10 months

Trial Locations

Locations (26): Comprehensive Cancer Centers of Nevada
🇺🇸
Henderson, Nevada, United States
Texas Cancer Center at Medical City
🇺🇸
Dallas, Texas, United States
Central Indiana Cancer Centers
🇺🇸
Fishers, Indiana, United States
New York Oncology Hematology, P.C.
🇺🇸
Albany, New York, United States
Tyler Cancer Center
🇺🇸
Tyler, Texas, United States
Cancer Care Northwest
🇺🇸
Spokane, Washington, United States
Minnesota Oncology Hematology, P.A.
🇺🇸
Minneapolis, Minnesota, United States
Rocky Mountain Cancer Center-Aurora
🇺🇸
Aurora, Colorado, United States
Northwest Cancer Specialists
🇺🇸
Portland, Oregon, United States
St. Mary's Medical Center
🇺🇸
Huntington, West Virginia, United States
The Jones Clinic
🇺🇸
Germantown, Tennessee, United States
Texas Oncology, P.A.
🇺🇸
Fort Worth, Texas, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Missouri Cancer Associates
🇺🇸
Columbia, Missouri, United States
Hematology Oncology Associates
🇺🇸
Phoenix, Arizona, United States
Florida Cancer Institute
🇺🇸
New Port Richey, Florida, United States
University of Michigan Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
Cancer Care & Hematology Specialists of Chicagoland
🇺🇸
Arlington Heights, Illinois, United States
West Texas Cancer Center
🇺🇸
Odessa, Texas, United States
Hematology Oncology Physicians of Texas
🇺🇸
Richardson, Texas, United States
Virginia Oncology Associates
🇺🇸
Chesapeake, Virginia, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Hematology/Oncology Associates
🇺🇸
Albuquerque, New Mexico, United States
Allison Cancer Center
🇺🇸
Midland, Texas, United States
HOAST - New Braunfels
🇺🇸
New Braunfels, Texas, United States
Oncology and Hematology Associates of SW Virginia, Inc.
🇺🇸
Salem, Virginia, United States