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

Completed · Phase 2

Conditions studied: Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT00440388

Run by

Ascenta Therapeutics

People needed

23

Starts

2006-10-01

Expected to finish

2008-11-01

Last updated by the study team

2010-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

• 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

Full record on ClinicalTrials.gov

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