Sirolimus/Tacrolimus Combination After HLA Matched Related Peripheral Blood Stem Cell Transplants

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2014

Conditions
Acute Leukemia in RemissionMyelodysplastic SyndromesLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated-Phase
Interventions
DRUG

Sirolimus

Sirolimus will be administered as a 6-mg oral loading dose beginning on day -1, followed by 3 mg per day orally in a single morning dose with a target trough level of 5-12 ng/mL. Trough levels will be measured once a week. Sirolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.

DRUG

Tacrolimus

Tacrolimus will be administered beginning on day -1 at 0.05 mg/kg intravenously by continuous infusion every 24 hours, with a target serum level of 5 to 10 ng/mL. Tacrolimus dosing is converted to oral capsules prior to discharge. Trough levels will be measured once a week. Tacrolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.

Trial Locations (1)

420-767

Soonchunhyang University Bucheon Hospital, Bucheon-si

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Asan Medical Center

OTHER

collaborator

Chonbuk National University Hospital

OTHER

collaborator

Chonnam National University Hospital

OTHER

collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

collaborator

Daegu Catholic University Medical Center

OTHER

collaborator

Ewha Womans University Mokdong Hospital

OTHER

collaborator

Gachon University Gil Medical Center

OTHER

collaborator

Inha University Hospital

OTHER

collaborator

Inje University

OTHER

collaborator

Keimyung University Dongsan Medical Center

OTHER

collaborator

Korea University Anam Hospital

OTHER

collaborator

Pusan National University Hospital

OTHER

collaborator

Samsung Medical Center

OTHER

collaborator

Severance Hospital

OTHER

collaborator

Seoul St. Mary's Hospital

OTHER

collaborator

Seoul National University Hospital

OTHER

collaborator

Soonchunhyang University Hospital

OTHER

lead

The Korean Society of Blood and Marrow Transplantation

OTHER

NCT01488253 - Sirolimus/Tacrolimus Combination After HLA Matched Related Peripheral Blood Stem Cell Transplants | Biotech Hunter | Biotech Hunter