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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.
First Received: February 3, 2006   Last Updated: December 4, 2008   History of Changes
Sponsored by: Ascenta Therapeutics
Information provided by: Ascenta Therapeutics
ClinicalTrials.gov Identifier: NCT00286780
  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 II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title: A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia

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
Arms Assigned Interventions
1: Experimental 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
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 UCSD Moores Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ascenta Therapeutics ( Brian Wood, Associate Director, Clinical Development )
Study ID Numbers: AT-101-CS-008
Study First Received: February 3, 2006
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00286780     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Contraceptive Agents
Rituximab
Contraceptive Agents, Female
Contraceptive Agents, Male
Gossypol acetic acid
Gossypol
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Retinol acetate
Antirheumatic Agents
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic
Antineoplastic Agents, Phytogenic

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

ClinicalTrials.gov processed this record on May 07, 2009