- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00286780
Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia
August 12, 2010 updated by: Ascenta Therapeutics
A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92093
- UCSD Moores Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of AT-101 in combination with rituximab
Time Frame: 5 months for each patient; 20 months entire study
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5 months for each patient; 20 months entire study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Preliminary efficacy of AT-101 in combination with rituximab
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Kipps, MD, PhD, University of California, San Diego
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
February 3, 2006
First Submitted That Met QC Criteria
February 3, 2006
First Posted (Estimate)
February 6, 2006
Study Record Updates
Last Update Posted (Estimate)
August 13, 2010
Last Update Submitted That Met QC Criteria
August 12, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Contraceptive Agents, Male
- Spermatocidal Agents
- Antispermatogenic Agents
- Gossypol acetic acid
Other Study ID Numbers
- AT-101-CS-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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