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

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.
 
ClinicalTrials.gov Identifier: NCT00286780
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : August 13, 2010
Sponsor:
Information provided by:
Ascenta Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: AT-101 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : January 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety of AT-101 in combination with rituximab [ Time Frame: 5 months for each patient; 20 months entire study ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
UCSD Moores Cancer Center
San Diego, California, United States, 92093
Sponsors and Collaborators
Ascenta Therapeutics
Investigators
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Principal Investigator: Thomas Kipps, MD, PhD University of California, San Diego
More Information
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Responsible Party: Brian Wood, Associate Director, Clinical Development, Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00286780    
Other Study ID Numbers: AT-101-CS-008
First Posted: February 6, 2006    Key Record Dates
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:
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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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Male