Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study

Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study - Post-CY haploHSCT with ATG (MAC)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009374

Enrollment

Registered

2012-11-21

Start date

2012-11-21

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

hematological malignancy

Interventions

Conditioning regimen and GVHD prophylaxis for allogeneic HSCT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) High risk hematological malignancy including AML, ALL, CML, HL, NHL, MDS (2) Those who do not have HLA-matched or 1-locus mismatched related donor/unrelated donor (3) Those who have HLA-haploidentical related donor (4) Age >=18, <=55 (5) ECOG PS 0 or 1 (6) Those who agree to the participation (7) Those who are expected to survive longer than 3 months

Exclusion criteria

Exclusion criteria: (1) Organ dysfunction (2) Uncontrolled hypertension (3) HIV positive (4) Uncontrolled active infection (5) Uncontrolled CNS invasion (6) Pregnant (7) Psychiatric disorder (8) Allergy to drugs used for HSCT (9) Other reason which physicians think the patient is inappropriate for the study

Design outcomes

Primary

Measure	Time frame
Day 60 engraftment and survival without grade III-IV acute GVHD	—

Secondary

Measure	Time frame
(1) 1-year OS and PFS (2) 1-year NRM (3) graft failure (4) engraftment rate (5) acute and chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse rate (8) infectious disease (9) immune reconstitution	—

Countries

Japan

Contacts

Public ContactShigeo Fuji

National Cancer Center Hospital Division of Hematopoietic Stem Cell Transplantation

sfuji@ncc.go.jp03-3542-2511

Outcome results

None listed

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