Safety and efficacy of umbilical cord blood (UCB) transplantation using a low-dose total body irradiation (TBI) containing regimen for hematologic malignancies

Not Applicable

• Conditions: Hematologic malignancies with an indication for allogeneic hematopoietic stem cell transplantation

• Registration Number: JPRN-UMIN000004338
• Lead Sponsor: Hematology, Osaka City University, Graduate School of Meicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients who have any major organ dysfunction as follow (a) Heart: Ejection fraction <30% at rest (b) Lung: %VC<30% or FEV1.0%<40% or PaO2<60mmHg(SpO2<90%) on room air (c) Kidney: serum creatinine level >2.0 mg/dl (d) Liver: total bilirubin level >2.0 mg/dl or ALT>3.0 x ULN (upper limit of normal) or chronic active hepatitis or cirrhosis (2) Poorly controlled hypertention (3) Positivity for HIV antibody (4) Uncontrolled active infections (5) Uncontrolled central nervous system involvement (6) Pregnant, nursing or possibly pregnant woman (7) Patients with mental disorder who are considered difficult to participate in the study (8) Known hypersensitivity to any of the drugs in the conditioning regimen or drugs used for GVHD prophylaxis (9) Patients with positive donor-specific HLA antibodies(DSA) (10) Engraftment failure after allogeneic hematopoietic stem cell transplantation (11) Inappropriate to participate in this study as judged by the physician in charge

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Day 60 survival rate of patients with successful engraftment after transplantation

Secondary Outcome Measures

Name	Time	Method
(1) Overall survival and progression free survival at day 100 (2) Non-relapse mortality at day 100 (3) Rate of primary graft failure, secondary graft failure (4) Time to hematopoietic recovery and achievement of complete donor T-cell chimerism (5) Incidence and severity of acute GVHD and chronic GVHD (6) Regimen-related toxicity (7) Rate of relapse (8) Incidence of bacterial, fungal and viral infection (9) Immune reconstitution after transplantation