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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440388
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : August 27, 2010
Information provided by:
Ascenta Therapeutics

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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: AT-101 Drug: Rituximab Phase 2

Detailed Description:
Further Study Details provided by Ascenta.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Intervention Details:
  • Drug: AT-101
    AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
  • Drug: Rituximab
    Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.

Primary Outcome Measures :
  1. complete or partial remission of disease [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. duration of complete or partial remission of disease [ Time Frame: 10 months ]
  2. number of participants with adverse events [ Time Frame: 10 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440388

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Sponsors and Collaborators
Ascenta Therapeutics
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Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.

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Responsible Party: Jeffrey Brill, Associate Director, Clinical Development, Ascenta Therapeutics Identifier: NCT00440388     History of Changes
Other Study ID Numbers: AT-101-CS-203
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010
Keywords provided by Ascenta Therapeutics:
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gossypol acetic acid
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male