CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming

Phase 3

Recruiting

• Conditions: Acute myelogenous leukemia or myelodysplastic syndrome; Myeloid hematological malignancy; C920; D469

• Registration Number: JPRN-jRCTs041180059
• Lead Sponsor: Terakura Seitaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

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 intermediate-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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified