Status:
TERMINATED
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Chronic Lymphocytic Leukemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leuk...
Detailed Description
Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work ...
Eligibility Criteria
Inclusion
- Patients with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, Richter's transformation or T-PLL who have previously been treated with fludarabine or another regime are eligible.
- Patients with histologically or cytologically confirmed Richter's transformation.
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than x 2 normal levels.
- Women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
- Women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
- Performance 0-2 (ECOG). Adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded).
- Signed informed consent.
Exclusion
- Breast feeding or pregnant females. Patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Known or suspected hypersensitivity to azacytidine or Mannitol.
- Active and uncontrolled infections.
- Patients with advanced malignant hepatic tumors.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00413478
Start Date
September 1 2006
End Date
November 1 2014
Last Update
June 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030