Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05335226
Collaborator
(none)
116
1
2
20.8
5.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
  • Procedure: haploidentical hematopoietic stem cell transplantation
N/A

Detailed Description

This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
Actual Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Haplo-HSCT group

58 patients will be involved in this group

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

Experimental: Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group

58 patients will be involved in this group

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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [12 months]

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

  2. Disease free survival [12 months]

    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

Secondary Outcome Measures

  1. Cumulative relapse incidence [12 months]

    Defined as the cumulative incidence of relapse after the day of transplantation

  2. Cumulative incidence of engraftment [12 months]

    Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10^9/L or more for three consecutive days , while platelet recovery difined as 20×10^9/L or more for seven consecutive days without transfusion

  3. cumulative incidence of acute graft-versus-host disease(GVHD) [12 months]

    Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria

  4. cumulative incidence of chronic GVHD at one year [12 months]

    chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)

  5. Cumulative Incidence of Infectious Complications [12 months]

    Defined as cumulative incidence of viral, fungal and bacterial infections

  6. Cumulative Incidence of hemorrhagic cystitis [12 months]

    Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation

  7. Cumulative Incidence of lymphoproliferative disease [12 months]

    Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin China 300041

Sponsors and Collaborators

  • Institute of Hematology & Blood Diseases Hospital

Investigators

  • Principal Investigator: Erlie Jiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT05335226
Other Study ID Numbers:
  • 20220410
First Posted:
Apr 19, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institute of Hematology & Blood Diseases Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022