Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor

Phase II study with tacrolimus to prevent GVHD for reduced-intensity peripheral blood stem cell transplantation from an HLA-identical related donor - Phase II study with tacrolimus to prevent GVHD for reduced-intensity PBSCT from an HLA-identical related donor

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001146

Enrollment

Registered

2008-06-01

Start date

2008-07-01

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

Acute leukemia, Chronic leukemia, Myelodysplastic syndrome, Malignant lymphoma, Adult T cell leukemia/lymphoma

Interventions

Use tacrolimus and short-term methotrexate as a GVHD prophylaxis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All of the following are required. (1)Age between 16 and 65 (2)Patients receiving PBSCT from an HLA-A,B,DR matched related donor (3)Any of the following is required. 1.Age 40 or older 2.Patients with hematopoietic stem cell transplantation- specific comorbidity index (HCT-CI) of one or more (4)Adult patients with hematological malignancy who need allogeneic transplantation (acute leukemia, chronic leukemia, myelodysplastic syndrome, malignant lymphoma, adult T cell leukemia/lymphoma) (5)Performance status(ECOG) 0 - 2 (6)Written informed consent to participate this trial

Exclusion criteria

Exclusion criteria: (1)Positive for HIV antibody andor HBs antigen (2)T cell depleted transplantation (3)Pregnant or during breast feeding (4)Uncontrolled psychiatric disease (5)Uncontrolled active infection (6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen (7)A history of intravenous chemotherapy within 21 days before transplantation (8)Cases that physicians judged as inappropriate

Design outcomes

Primary

Measure	Time frame
Incidence of grade II-IV acute GVHD at 100 days after PBSCT	—

Secondary

Measure	Time frame
Incidence of chronic GVHD, overall survival rate at 2 years, nonrelapse mortality rate at 2 years, relapse rate at 2 years, treatment-associated toxicity, term to hematopoietic recovery	—

Countries

Japan

Contacts

Public ContactYoshihiro Inamoto

Nagoya University Graduate School of Medicine Department of Hematology and Oncology

yinamoto@med.nagoya-u.ac.jp052-744-2145

Outcome results

None listed

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