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Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Leukemia

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Trial Information

Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

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 better.

Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have
blood drawn (about 3 teaspoons) to check your kidney and liver function (routine blood
tests). You may have a bone marrow aspiration performed (if you have not had one in recent
weeks). To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with
anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who
are able to have children must have a negative urine pregnancy test.

If you agree to take part in this study, you will receive azacytidine by subcutaneous (just
under the skin) injection every day for 7 days. This course of treatment will be repeated
every 3-8 weeks, depending on the results of your routine blood tests.

Your doctor may increase or decrease your dose of azacytidine, depending on if you
experience any side effects. You will continue to receive treatment on this study unless the
disease gets worse or you experience any intolerable side effects. If the disease gets worse
or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. This is an investigational study. Azacytidine has been
approved by the FDA for the treatment of myelodysplastic syndrome. Up to 37 patients will
take part in this study. All will be enrolled at M. D. Anderson.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Response Rate (Complete, Partial)

Outcome Time Frame:

Approximately every 3-8 weeks.

Safety Issue:


Principal Investigator

Zeev Estrov, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

September 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • 5-Aza
  • Azacytidine
  • Vidaza
  • CLL
  • Chronic Lymphocytic Leukemia
  • Richter's transformation
  • Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



UT MD Anderson Cancer Center Houston, Texas  77030