Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy

Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy - Phase II study to evaluate the efficacy of intra-bone cord blood transplantation for adult patients with hematological malignancy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020997

Enrollment

Registered

2016-04-01

Start date

2016-04-01

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

Hematological malignancy

Interventions

1. Intra-bone infusion of cord blood cells 2. Any preconditioning including both myeloablative and non-myeloablative regimens are allowed 3. Any GVHD prophylaxis except in vivo T cell depletion are

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hematological malignancy 2. Age: 16 yr or older 3. Performance status (ECOG): 0 to 2 4. Cord blood unit: HLA-A, B, DR serotypes 4/6 match, total nuclear cell count at 2.0 x 10e7/kg or higher, prioritize cord blood unit containing more CD34 positive cells, and prioritize cord blood unit without HLA corresponding to HLA antibody in patient serum 5. Neither uncontrolled heart failure nor uncontrolled ECG abnormality 6. No need for oxygen administration 7. AST: less than 5 x ULN, ALT: less than 5 x ULN, T-Bil: less than 3 x ULN 8. Cre: less than 3 x ULN 9. Patient's agreement to participate in this study

Exclusion criteria

Exclusion criteria: 1. Positive for HBs-Ag, HCV-Ab, or HIV-Ab 2. In pregnancy or breast-feeding 3. Double cancer 4. Uncontrolled psychiatric disorder 5. Uncontrolled infectious disease 6. Allergy to drugs for transplant preconditioning or GVHD prophylaxis 7. Re-transplantation within 6 months from the preceding transplantation 8. Doctor's decision

Design outcomes

Primary

Measure	Time frame
Survival rate with neutrophil engraftment on day 28 after transplantation	—

Countries

Japan

Contacts

Public ContactTetsuya Nishida

Nagoya University Graduate School of Medicine Hematology and Oncology

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

Outcome results

None listed

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