Study to Assess the Safety and Efficacy of Tacrolimus (Prograf Capsule/Injection) and Methotrexate (MTX) Combination Therapy for Prevention of Graft Versus Host Disease (GVHD) in Patients Who Received Peripheral Hematopoietic Stem Cell Transplantation From a Sibling Donor

Astellas

Status and phase

Completed

Phase 4

Conditions

Graft Versus Host Disease

Treatments

Drug: Cyclosporine

Drug: Methotrexate

Drug: Prograf

Study type

Interventional

Funder types

Industry

Identifiers

NCT02660684

PRG-07-11-KOR

Details and patient eligibility

About

The objective of this study is to assess the safety and efficacy of Tacrolimus (Prograf capsule, Prograf injection) and Methotrexate combination therapy for GVHD prophylaxis in patients who received peripheral hematopoietic stem cell transplantation from a sibling donor, and to compare with data from a historical control group that administered a conventional Cyclosporine formulation.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Blood diseases for a standard risk group
- Primary remission of AML (acute myeloid leukemia)
- Primary remission of ALL (acute lymphocytic leukemia)
- Secondary remission of ALL (acute lymphocytic leukemia)
- SAA (severe aplastic anemia)
- Chronic stage CML (chronic myeloid leukemia)
- MDS (myelodysplastic syndrome)
- Myeloma (multiple myeloma)
A patient who received peripheral hematopoietic stem cell transplantation from a HLA-matched sibling donor

Exclusion criteria

A patient with renal impairment (serum creatinine level ≥ 1.5mg/dl or 130μmol/l, GFR≤ 30%)
A pregnant or breastfeeding woman
A woman who is unwilling or unable to practice appropriate contraception during the study
A patient who is highly likely to experience aggravation during treatment due to active tuberculosis, other hepatic disease, hypertension, heart failure, chronic obstructive respiratory disease, etc.
A patient with hypersensitivity to tacrolimus