Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
Ascenta Therapeutics
ClinicalTrials.gov Identifier:
NCT00286780
First received: February 3, 2006
Last updated: August 12, 2010
Last verified: August 2010
  Purpose

This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: AT-101
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Ascenta Therapeutics:

Primary Outcome Measures:
  • Safety of AT-101 in combination with rituximab [ Time Frame: 5 months for each patient; 20 months entire study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preliminary efficacy of AT-101 in combination with rituximab [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AT-101
80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLL as defined by the NCI-working group
  • Previous treatment with standard systemic chemotherapy or immunotherapy.
  • Disease progression or relapse after treatment.
  • Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
  • ECOG performance status ≤ 2
  • Adequate liver and renal and bone marrow function

Exclusion Criteria:

  • Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
  • Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
  • Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
  • Active secondary malignancy or history of other malignancy within the last five years
  • Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
  • Patients who are contraindicated for treatment with rituximab
  • Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
  • T-CLL or other T-cell malignancy
  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: NCT00286780

Locations
United States, California
UCSD Moores Cancer Center
San Diego, California, United States, 92093
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
Principal Investigator: Thomas Kipps, MD, PhD University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00286780     History of Changes
Other Study ID Numbers: AT-101-CS-008
Study First Received: February 3, 2006
Last Updated: August 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Ascenta Therapeutics:
AT101
AT-101
cancer
lymphoctic
lukemia
Rituximab

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
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 September 18, 2014