Status:
COMPLETED
Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
Ascenta Therapeutics
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-1...
Detailed Description
Further Study Details provided by Ascenta.
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00440388
Start Date
October 1 2006
End Date
November 1 2008
Last Update
August 27 2010
Active Locations (28)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35296
2
Hematology Oncology Associates
Phoenix, Arizona, United States
3
Rocky Mountain Cancer Center-Aurora
Aurora, Colorado, United States
4
Florida Cancer Institute
Hudson, Florida, United States, 34667