A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming

A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming - CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029947

Enrollment

160

Registered

2018-02-01

Start date

2018-01-15

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

Myelogenous Hematological Malignancies

Interventions

To add G-CSF priming to the conditioning regimen concomittantly with two days of Ara-C. Not to add G-CSF to the conditioning regimen.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.First stem cell transplantation including autologous or allogeneic. 2.Hematological disease listed below. -Acute myelogenous leukemia -Myelodysplastic syndrome, RAEB-1 or RAEB-2. Either intemediate-II or high in IPSS. High or very-high in WPSS. Relapsed after CR. 3.Obtained informed consent 4.Performance status 0,1,2 5.appropriate cord blood is available 6.appropriate organ function

Exclusion criteria

Exclusion criteria: 1.HBs antigen positive 2.HCV antibody positive 3.HIV antibody positive 4 Donor-specific anti-HLA antibody positive 5.Use of gemtuzumab ozogamicin within 6 months before transplantation 6.During pregnant or breast-feeding 7. Uncontrollable psychiatric disorder 8. Uncontrollable infection 9. Allergy for any drug used in the conditioning regimen or GVHD-prophylaxis 10.Considered to be unfit for the study enrollment by the physician

Design outcomes

Primary

Measure	Time frame
2-year disease-free survival	—

Secondary

Measure	Time frame
1) Time to hematopoietic recovery 2) Engraftment rate 3) Treatment-related toxicity until day 28 4) Mucosal toxicity grade until day 42 (maximum grade and incidence) 5) Maximum dose of narcotic drug per day until day 42 6) Incidence and severity of acute GVHD 7) Incidence and severity of chronic GVHD 8) Treatment-related mortality at day 100 and 2 years after transplantation 9) Relapse rate at 2 years after transplantation 10) Overall survival (OS) at 2 years after transplantation 11) Incidence of infectious event (causative bacteria or other microorganisms, site of infection, day of onset, frequency) 12) Causes of deaths	—

Measure

Time frame

1) Time to hematopoietic recovery 2) Engraftment rate 3) Treatment-related toxicity until day 28 4) Mucosal toxicity grade until day 42 (maximum grade and incidence) 5) Maximum dose of narcotic drug per day until day 42 6) Incidence and severity of acute GVHD 7) Incidence and severity of chronic GVHD 8) Treatment-related mortality at day 100 and 2 years after transplantation 9) Relapse rate at 2 years after transplantation 10) Overall survival (OS) at 2 years after transplantation 11) Incidence of infectious event (causative bacteria or other microorganisms, site of infection, day of onset, frequency) 12) Causes of deaths

—

Countries

Japan

Contacts

Public ContactSeitaro Terakura

Nagoya University Hospital Department of Hematology

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

Outcome results

None listed

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