Return to List

Study Summary
No. 2008-0087:.......Blood And Marrow Transplantation; Leukemia......Richard E. Champlin......Stem Cell Transplantation and Cellular Therapy
.
Study Summary Title
Study Summary
Number:
2008-0087
Study Title:Azacitidine maintenance therapy after allogeneic stem cell transplantation for CML (VZ-CML-PI-0130)
.
Physician New Patient Referral
Name:Richard E. ChamplinPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8750
Contact us about clinical trials
.
General Information
Disease Group:Blood And Marrow Transplantation
Leukemia
Supported By:Celgene Corporation
NCI
Phase of Study:Phase IIReturn
Visit:
Patients are to return to MDACC as clinically indicated. Usually, for 7-14 days
they will come daily, and subsequently, on a 2-3 / week basis, until transplant
day + 100. In addition, they are expected to return 6, 9 and 12 months after
transplant.
Treatment
Agents:
ATG
Azacitidine
Busulfan
Fludarabine
G-CSF
Tacrolimus
Home Care:Protocol treatment is to be given in a hospital/clinic basis.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Transplant: approximately 30 days in the hospital. Readmissions may occur, as
clinically indicated.
Description/
Intervention:
The goal of laboratory research study is to learn patterns of methylation.
Methylation is a process by which the body may turn "on and off" certain genes.
The patient who receives your stem cells will be treated with a drug that
interferes with this process and researchers will use your blood to make a
profile of your cells, which will be compared to the profile of the cells taken
from your recipient after the transplant.
.
Study Objectives / Outcomes
To determine if post transplant treatment with 5-azacytidine will increase the rate of cytogenetic complete remission in patients with CML following allogeneic stem cell transplantation from an HLA compatible donor compared to historical controls.

To determine the rate of engraftment, chimerism, graft-vs-host disease, and
survival.
.
Study Status Information
Study Activation / Registration Date:12/17/2008
IRB Review and Approval Date:11/05/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
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 age <= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible.

2) Patients with age <= 75 with CML in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.

3) Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).

4) Age 18 to 75 years.

5) Zubrod performance status <= 2.

6) Left ventricular ejection fraction => 40%.

7) Pulmonary function test within the following parameters: FEV1, FVC and DLCO => 50% of expected, corrected for hemoglobin.

8) Serum creatinine < 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min.

9) Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)

10) SGPT <= 200 IU/L unless related to patient's malignancy.

11) Patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.

12) Patients with age <75 years with CML in second or subsequent chronic phase.

Exclusion Criteria:1) Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.

2) Pleural/pericardial effusion or ascites estimated to be >1L.

3) HIV-positive.

4) Breast feeding or pregnancy. Pregnancy means a positive beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

5) Known or suspected hypersensitivity to azacitidine or mannitol.

6) Patients with advanced malignant hepatic tumors.

.
Links
Registration Number: NCT00813124
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center