5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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 leukemia (T-PLL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Celgene Corporation
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

1. 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.

2. Patients with histologically or cytologically confirmed Richter's transformation.

3. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than x 2 normal levels.

4. Women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.

5. Women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.

6. 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).

7. Signed informed consent.

Exclusion Criteria:

1. 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.

2. Known or suspected hypersensitivity to azacytidine or Mannitol.

3. Active and uncontrolled infections.

4. Patients with advanced malignant hepatic tumors.

5. 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.