MDACC Study Summary 2005-0417 (Archived)

Study Summary
No. 2005-0417:.......Blood And Marrow Transplantation; Leukemia......Marcos de Lima......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0417

Study Title:	Azacitidine maintenance therapy after allogeneic hematopoietic stem cell transplantation for AML and MDS

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:	N/A

Phase of Study:	Phase I	Return Visit:	Daily visits for 5 days (study drug administration), on the first 5 days of 4 cycles of 30 days (starting: 6th or 7th week post transplant). Return visits: 4, 6 and 12 months after transplant. Other visits may be necessary as clinically indicated.

Treatment Agents:	5-Azacytidine ERROR: Incorrect data type for operator or @Function: Text expected	Home Care:	There is no home care related to this protocol.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Hospitalization is planned for the first 5 weeks of treatment (approximately one week prior, 4 weeks after transplant). Other admissions are not part of this study, but may be required for the treatment of infections and other complications.


Description/ Intervention:	The goal of this clinical research study is to find the safest combination of dose and schedule of administration of the drug 5-azacitidine (azacitidine, or Vidaza) that can be given to patients with AML and MDS after an allogeneic (donor) stem cell transplantation. The effectiveness of this treatment will also be studied.

Study Objectives / Outcomes

Primary
To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS.

Secondary
To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.

Study Status Information



Study Activation / Registration Date:	10/11/2005

IRB Review and Approval Date:	08/03/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

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 a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in

2) Induction Failure, relapsed disease or second or greater remission.

3) Patients in first complete remission that required more than 1 cycle of treatment to achieve the remission.

4) Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or

5) HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch)

6) Age 18 to 75 years and

7) Left ventricular ejection fraction >40% and

8) FEV1, FVC and DLCO >40% and

9) Serum creatinine <1.6 mg/dL and

10) Serum bilirubin < 1.6 mg/dL and

11) SGPT < 3 X upper limit of normal and

12) All patients and donors or guardian should be able to understand and sign informed consent.

13) Women of childbearing potential (any female who has experienced menarch, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test.

Exclusion Criteria:

1) HIV positive

2) AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.)

3) Active uncontrolled infection

4) Pregnancy or breastfeeding

Links

Registration Number: NCT00350818
Study Information on Clinical Trials Registry (clinicaltrials.gov)