A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY)

A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY) - KSGCT1201 / NIH-GVHD STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007793

Enrollment

400

Registered

2012-04-20

Start date

2012-04-01

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

Allogeneic hematopoietic stem cell transplantation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who undergo allogeneic stem cell transplantation for the first time 2. Age 16 or over at transplantation 3. Provided written informed consent in accordance with the Declaration of Helsinki.

Exclusion criteria

Exclusion criteria: Patients without written informed consent.

Design outcomes

Primary

Measure	Time frame
Evaluate weather global severity of NIH-GVHD associates with GVHD specific survival and the time to immunosuppressant withdrawal.	—

Secondary

Measure	Time frame
Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Non-relapse mortality Relapse rate Incidence of secondary malignancy Cumulative incidence of NIH-GVHD Distribution of organ specific severity Risk factor for the onset of NIH-GVHD Treatment outcome of NIH-GVHD	—

Measure

Time frame

Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Evaluate the association of classification and global severity of NIH-GVHD with following parameters; Overall survival Non-relapse mortality Relapse rate Incidence of secondary malignancy Cumulative incidence of NIH-GVHD Distribution of organ specific severity Risk factor for the onset of NIH-GVHD Treatment outcome of NIH-GVHD

—

Countries

Japan

Contacts

Public ContactChikako Ohwada

Kanto Study Group for Cell Therapy Trial Office

chikako_ohwada@faculty.chiba-u.jp03-6225-2040

Outcome results