Status:
TERMINATED
Sirolimus/Tacrolimus Combination After HLA Matched Related Peripheral Blood Stem Cell Transplants
Lead Sponsor:
The Korean Society of Blood and Marrow Transplantation
Collaborating Sponsors:
Asan Medical Center
Chonbuk National University Hospital
Conditions:
Acute Leukemia in Remission
Myelodysplastic Syndromes
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
Brief Summary
Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a graft-versus-host disease prophylaxis, the investigators are going to perform a phase II, multicenter clinica...
Detailed Description
Rationale: Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic HSCT. The combination of a calcineurin inhibitor and methotrexate has been the standard GV...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent prior to participating to the study
- Patients with acute leukemia in remission, MDS, and CML in chronic \& accelerated phase
- Patients with HLA identical donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.
- Patients with an ECOG performance status score \< 2
- Adequate end organ functions as defined by: Total bilirubin \< 1.5 × ULN, AST and ALT \< 2.5 × ULN, Creatinine \< 1.5 × ULN.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug.
Exclusion
- Acute promyelocytic leukemia (M3)
- Patients with another primary malignancy other than hematologic disease
- Patients with a severe or uncontrolled medical condition (i.e. uncontrolled diabetes, chronic renal disease)
- Patients who are ① pregnancy, ② breast feeding, ③ of childbearing potential without a negative pregnancy test prior to baseline and ④ male or female of childbearing potential unwilling to use barrier contraceptive precautious throughout the trial (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)
- Patients with an ECOG performance status score ≥ 2
- Patients with known positivity for HIV; baseline testing for HIV is not required
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01488253
Start Date
January 1 2012
End Date
October 1 2014
Last Update
April 3 2015
Active Locations (1)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea, 420-767