MDACC Study Summary 2006-0428

Study Summary
No. 2006-0428:.......Leukemia......Zeev Estrov......Leukemia

Study Summary Title



Study Summary Number:	2006-0428

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

Physician

New Patient Referral



Name:	Zeev Estrov	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1675 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	As clinically indicated.

Treatment Agents:	5-Azacytidine	Home Care:	This treatment can be given by the patient's oncologist at the discretion of the PI of the study.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable.


Description/ Intervention:	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.

Study Objectives / Outcomes

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).

Study Status Information



Study Activation / Registration Date:	09/21/2006

IRB Review and Approval Date:	07/19/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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.

Links

Registration Number: NCT00413478
Study Information on Clinical Trials Registry (clinicaltrials.gov)