Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation

Evaluation of safety and efficacy of tranilast in preventing graft-versus-host disease after allogeneic hematopoietic stem cell transplantation - Tranilast in preventing GVHD after allogeneic HSCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016401

Enrollment

Registered

2015-02-10

Start date

2015-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paients aged 20 years or greater who undergo allogeneic hematopoietic stem cell transplatation from an unrelated donor

Interventions

Administration of tranilast to hematopoietic stem cell transplant recipients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 years old or greater at consent 2) Hematologial disorder which has indication for allogeneic HSCT 3) Available unrelated donor who are donating bone marrow or PBSC, fulfilling the following criteria (1)HLA-A,B,DR serologically and genetically matched (2)HLA-A,B,DR serologially matched, but 1 or 2 loci genetically mismatched. (3) HLA-A,B,DR 1 locus-mismatched, but genetically matched in other loci. 4) Any conditioning regimen applicable. In patients with 3)(3) donor, anti-thymocyte globulin can be used. 5) Tacrolimus and short-term methotrexate are used for GVHD prophylaxis. 6) ECOG PS 0 or 1. 7) No major organ dysfunction (1) SaO2 94% or greater (2) Serum Cr 1.5 mg/dl or less (3) Serum T. Bil 2.0 mg/dl or less (4) AST and ALT x3 institutional upper limit or less (5) Without abnormalities in electrocardiogram requiring treatment (6) Ultracardiography ejection fraction 55% or greater

Exclusion criteria

Exclusion criteria: 1) Poorly controlled diabetes even with insulin treatment 2) Poorly controlled hypertension 3) Poorly controlled active infection 4) Not expecting 3 months or longer survival due to refractory disease or infection 5) Requring immediate tapering of immunosuppressant because of high risk of disease replapse 6) Active disease infiltration of central nervous system 7) Active double cancer 8) Pregnant or nursing patients 9) Poorly controlled psychiatric disorder 10) History of hypersensitivity or moderate or greater adverse events due to tranilast, cyclosporine, tacrolimus, and methotrexate.

Design outcomes

Primary

Measure	Time frame
Non-hematological adverse events within 28 days after transplantation	—

Countries

Japan

Contacts

Public ContactTakehiko MORI

Keio University School of Medicine Division of Hematology

tmori@a3.keio.jp0333531211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026