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

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Leukemia

In brief

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).

Key facts

Study ID

NCT00413478

Run by

M.D. Anderson Cancer Center

People needed

9

Starts

2006-09-01

Expected to finish

2014-11-01

Last updated by the study team

2015-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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