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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:
ClinicalTrials.gov Identifier:
NCT00286780
First Posted: February 6, 2006
Last Update Posted: August 13, 2010
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.
Information provided by:
Ascenta Therapeutics
  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: None (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 ]

Secondary Outcome Measures:
  • Preliminary efficacy of AT-101 in combination with rituximab [ Time Frame: 5 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 3, 2006
First Posted: February 6, 2006
Last Update Posted: August 13, 2010
Last Verified: August 2010

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Gossypol acetic acid
Rituximab
Gossypol
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