NCT05103995

Brief Summary

the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

6.2 years

First QC Date

October 10, 2021

Last Update Submit

October 22, 2021

Conditions

Hematological MalignanciesHaploidentical Stem Cell Transplantation

Keywords

haploidentical stem cell transplantationhematological malignanciesABO incompatibility

Outcome Measures

Primary Outcomes (1)

  • 5-year Overall Survival

    5-year Overall Survival

    5 year

Secondary Outcomes (9)

  • 5-year Non-relapse mortality

    5 year

  • 5-year cumulative incidence of chronic graft versus host disease

    5 year

  • 28-day cumulative incidence of neutrophils engraftment

    28 day

  • 28-day cumulative incidence of platelets engraftment

    28 day

  • 365-day blood transfusion requirements

    365 day

  • +4 more secondary outcomes

Study Arms (4)

ABO matched

Donor-recipient ABO matched

Other: no intervention

Minor incompatibility

Donor-recipient minor incompatibility

Other: no intervention

Major incompatibility

Donor-recipient major incompatibility

Other: no intervention

Bidirectional incompatibility

Donor-recipient bidirectional incompatibility

Other: no intervention

Interventions

no interventionOTHER

no intervention, just observation

ABO matchedBidirectional incompatibilityMajor incompatibilityMinor incompatibility

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation

You may qualify if:

  • \. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.

You may not qualify if:

  • Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase \> 2.5 times of the upper normal limit, serum creatinine \> 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction \< 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score \> 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The first Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Affiliated Jinhua hospital of Zhejiang University

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2021

First Posted

November 2, 2021

Study Start

January 1, 2013

Primary Completion

March 31, 2019

Study Completion

October 1, 2021

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)