Return to List

Study Summary
No. P02-244:.......Pediatrics; Blood and Marrow Transplantation; Hematologic Disorder; Leukemia; Lymphoma......Demetrios Petropoulos......Pediatrics
.
Study Summary Title
Study Summary
Number:		P02-244
Study Title:CYTOKINE GENE POLYMORPHISMS IN PEDIATRIC PATIENTS RECEIVING TACROLIMUS OR CYCLOSPORINE FOR GRAFT VERSUS HOST DISEASE PROPHYLAXIS. A PEDIATRIC BLOOD AND MARROW TRANSPLANT CONSORTUIM STUDY
.
Physician New Patient Referral
Name:Demetrios PetropoulosPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3746
Contact us about clinical trials
.
General Information
Disease Group:Pediatrics
Blood and Marrow Transplantation
Hematologic Disorder
Leukemia
Lymphoma		Supported By:none
Phase of Study:Phase IIReturn
Visit:		No additional visits other than standard of care.
Treatment
Agents:		FK 506
Cyclosporin-A		Home Care:Standard of care according to clinical need.
Treatment Loc:inpatient
Estimated
Length of Stay
in Houston:		This is a data collection study. Patient will be followed according to standard of care procedure for unrelated donor stem cell transplant.
Description/
Intervention:		Unavailable
.
Study Objectives / Outcomes
Unavailable
.
Study Status Information
Study Activation / Registration Date:09/25/2002
IRB Review and Approval Date:07/03/2002
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:10
.
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:The patient is scheduled to receive a bone marrow transplant from an unrelated donor.

The donor must be a genotypic match based upon intermediate resolution molecular typing of class I loci (HLA-A, and B loci) and high resolution molecular typing for DRB1 loci. For centers in which high resolution typing of class I loci is routinely performed, a one antigen minor allelic mismatch is allowed.

The patient is < 21 years of age at the time of study entry.
Exclusion Criteria:The patient is receiving full or partial T-depleted marrow or T-depleted peripheral stem cell transplants.

The patient is receiving sub-ablative or non-myeloablative transplant conditioning regimen.

The patient is receiving umbilical cord blood transplants.

The patient has a serum creatinine >1.5 mg/dl, or creatinine clearance (or GFR) <60 ml/min/1.72 m (squared) at study entry.

The patient has an SGOT (AST) OR SGPT (ALT) >5x ULN or serum bilirubin >2.0 mg/dl at study entry.

The patient has a baseline shortening fraction <28% on echocardiogram, or left ventricular ejection fraction <50% on MUGA scan.

The patient has a Karnofsky/Lansky score less than or equal to 60% at study entry.

The patient has had an allogeneic hematopoietic cell transplantation within the past 12 months.
.
Links
Registration Number:
Other Links:
.
Results

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