NCT05335226

Brief Summary

Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

April 12, 2022

Last Update Submit

August 9, 2022

Conditions

Acute Leukemia

Keywords

Acute Leukemiahaplo-hematopoietic stem cell transplantation (haplo-HSCT)umbilical cord blood stem cell transplantation (UCBT)

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up

    12 months

  • Disease free survival

    Defined as the time starting at the day of transplantation, terminating at the day when the sign of AL is found or the end of follow-up

    12 months

Secondary Outcomes (7)

  • Cumulative relapse incidence

    12 months

  • Cumulative incidence of engraftment

    12 months

  • cumulative incidence of acute graft-versus-host disease(GVHD)

    12 months

  • cumulative incidence of chronic GVHD at one year

    12 months

  • Cumulative Incidence of Infectious Complications

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Haplo-HSCT group

EXPERIMENTAL

58 patients will be involved in this group

Procedure: haploidentical hematopoietic stem cell transplantation

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group

EXPERIMENTAL

58 patients will be involved in this group

Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation

Interventions

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantationPROCEDURE

Patients will receive umbilical cord blood allogeneic stem cell transplantation at the same day as the haploidentical stem cell transplantation. (HLA 6-10/10, TNC≥1-3×10-7/Kg)

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group
haploidentical hematopoietic stem cell transplantationPROCEDURE

Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)

Haplo-HSCT group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 16-65 years inclusive.
  • Diagnosed as acute leukemia, planning to receive haplo-HSCT
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Presence of an available haploidentical donor
  • Signing written informed consent and agreeing with taking designated umbilical cord blood

You may not qualify if:

  • Uncontrolled infections less than 4 weeks prior to enrollment
  • Secondary malignancy
  • Psychiatric illness that would limit compliance with study requirements
  • Impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
  • Allergic to blood products
  • Other causes which are not suitable for the trial in investigator's consideration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300041, China

RECRUITING

Study Officials

  • Erlie Jiang

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiming Pang

CONTACT

+86-13820398091pangaiming@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

June 6, 2022

Primary Completion

November 1, 2023

Study Completion

March 1, 2024

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

CN(1)