MDACC Study Summary 2008-0087

Study Summary
No. 2008-0087:.......Blood And Marrow Transplantation; Leukemia......Marcos de Lima......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:	Marcos de Lima	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring 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 II	Return 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 complete molecular 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/ml 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)