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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

Phase 2
18 Years
Not Enrolling
Follicular Lymphoma

Thank you

Trial Information

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

Further Study Details provided by Ascenta.

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;

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete or partial remission of disease

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

November 2008

Related Keywords:

  • Follicular Lymphoma
  • cancer
  • lymphoma
  • Non-Hodgkin's
  • Non-Hodgkins
  • AT-101
  • AT101
  • Rituxan
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



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