NCT00440388CompletedPhase 2
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
Ascenta Therapeutics28 sites in 1 country23 target enrollmentStarted: October 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 28
- Primary Endpoint
- complete or partial remission of disease
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
complete or partial remission of disease
Time Frame: 8 weeks
Secondary Outcomes
- number of participants with adverse events(10 months)
- duration of complete or partial remission of disease(10 months)
Investigators
Study Sites (28)
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