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

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00440388
First received: February 23, 2007
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Follicular Lymphoma
Drug: AT-101
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • complete or partial remission of disease [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of complete or partial remission of disease [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • number of participants with adverse events [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: October 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.
Detailed Description:

Further Study Details provided by Ascenta.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440388

  Show 28 Study Locations
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
Study Director: Lance Leopold, MD Ascenta Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Jeffrey Brill, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00440388     History of Changes
Other Study ID Numbers: AT-101-CS-203
Study First Received: February 23, 2007
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
cancer
lymphoma
Non-Hodgkin's
Non-Hodgkins
AT-101
AT101
Rituxan
Rituximab

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Gossypol acetic acid
Gossypol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Phytogenic
Contraceptive Agents, Female
Spermatocidal Agents
Antispermatogenic Agents

ClinicalTrials.gov processed this record on October 01, 2014