5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Celgene Corporation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00413478

Purpose

The goal of this clinical research study is to learn the effectiveness of Vidaza (azacytidine) in the treatment of patients with CLL that has returned after previous treatments and where there is currently no standard treatment for the disease at this stage. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia Leukemia	Drug: 5-Azacytidine	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Azacitidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL) and Richter's transformation. [ Time Frame: September 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL) and Richter's transformation. [ Time Frame: September 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	37
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 5-Azacytidine	Drug: 5-Azacytidine 75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.

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 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. Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome. It will be provided free of charge while you are on this study. Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia, or Richter's transformation who have previously been treated with fludarabine 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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413478

Contacts

Contact: Zeev Estrov, MD

713-794-1675

zestrov@mdanderson.org

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Zeev Estrov, MD 713-794-1675
Principal Investigator: Zeev Estrov, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Celgene Corporation

Investigators

Principal Investigator:

Zeev Estrov, MD

M.D. Anderson Cancer Center

More Information

(MD Anderson's website) This link exits the ClinicalTrials.gov site

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Zeev Estrov, M.D., Professor )
Study ID Numbers:	2006-0428
Study First Received:	December 15, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00413478
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

5-Aza
Azacytidine
Vidaza
CLL

Chronic Lymphocytic Leukemia
Richter's transformation
Leukemia

Study placed in the following topic categories:

Richter syndrome
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Azacitidine
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009