Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma
Information source: Ascenta Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Follicular Lymphoma
Intervention: AT-101 (Drug); Rituximab (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Ascenta Therapeutics Official(s) and/or principal investigator(s):
Lance Leopold, MD, Study Director, Affiliation: Ascenta Therapeutics, Inc.
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Assess the 8-week overall response rate of AT-101 in combination with rituximab.
Secondary outcome: Assess the complete response rate, duration of response, and progression free survival of AT-101 in combination with rituximab.Confirm the safety of AT-101 in combination with rituximab.
Detailed description:
Further Study Details provided by Ascenta.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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;
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35296, United States
Hematology Oncology Associates, Phoenix, Arizona, United States
Rocky Mountain Cancer Center-Aurora, Aurora, Colorado, United States
Florida Cancer Institute, Hudson, Florida 34667, United States
Florida Cancer Institute, New Port Richey, Florida 34655, 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 48109, 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 87106, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Duke University Medical Center, Durham, North Carolina 27707, United States
Northwest Cancer Specialists, Portland, Oregon, United States
The Jones Clinic, Germantown, Tennessee 38138, United States
Texas Oncology, P.A., Bedford, Texas, United States
HOAST - New Braunfels, New Braunfels, Texas, United States
West Texas Cancer Center, Odessa, Texas, United States
Tyler Cancer Center, Tyler, 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
Hematology Oncology Physicians of Texas, Richardson, Texas 75080, United States
Virginia Oncology Associates, Chesapeake, Virginia, United States
Oncology and Hematology Associates of SW Virginia, Inc., Salem, Virginia 24153, United States
Cancer Care Northwest, Spokane, Washington 99202, United States
St. Mary's Medical Center, Huntington, West Virginia 25701, United States
Additional Information
Starting date: October 2006
Ending date: August 2008
Last updated: April 30, 2008
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