search
Back to results

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

Primary Purpose

Acute Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
haploidentical hematopoietic stem cell transplantation
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring Acute Leukemia, haplo-hematopoietic stem cell transplantation (haplo-HSCT), umbilical cord blood stem cell transplantation (UCBT)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Haplo-HSCT group

Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group

Arm Description

58 patients will be involved in this group

58 patients will be involved in this group

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Cumulative relapse incidence
Defined as the cumulative incidence of relapse after the day of transplantation
Cumulative incidence of engraftment
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
cumulative incidence of acute graft-versus-host disease(GVHD)
Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria
cumulative incidence of chronic GVHD at one year
chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)
Cumulative Incidence of Infectious Complications
Defined as cumulative incidence of viral, fungal and bacterial infections
Cumulative Incidence of hemorrhagic cystitis
Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation
Cumulative Incidence of lymphoproliferative disease
Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation

Full Information

First Posted
April 12, 2022
Last Updated
August 9, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
search

1. Study Identification

Unique Protocol Identification Number
NCT05335226
Brief Title
Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
Official Title
The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
Keywords
Acute Leukemia, haplo-hematopoietic stem cell transplantation (haplo-HSCT), umbilical cord blood stem cell transplantation (UCBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Haplo-HSCT group
Arm Type
Experimental
Arm Description
58 patients will be involved in this group
Arm Title
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group
Arm Type
Experimental
Arm Description
58 patients will be involved in this group
Intervention Type
Procedure
Intervention Name(s)
Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
haploidentical hematopoietic stem cell transplantation
Intervention Description
Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)
Primary Outcome Measure Information:
Title
Overall survival
Description
Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up
Time Frame
12 months
Title
Disease free survival
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cumulative relapse incidence
Description
Defined as the cumulative incidence of relapse after the day of transplantation
Time Frame
12 months
Title
Cumulative incidence of engraftment
Description
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
Time Frame
12 months
Title
cumulative incidence of acute graft-versus-host disease(GVHD)
Description
Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria
Time Frame
12 months
Title
cumulative incidence of chronic GVHD at one year
Description
chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)
Time Frame
12 months
Title
Cumulative Incidence of Infectious Complications
Description
Defined as cumulative incidence of viral, fungal and bacterial infections
Time Frame
12 months
Title
Cumulative Incidence of hemorrhagic cystitis
Description
Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation
Time Frame
12 months
Title
Cumulative Incidence of lymphoproliferative disease
Description
Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aiming Pang
Phone
+86-13820398091
Email
pangaiming@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erlie Jiang
Organizational Affiliation
Institute of Hematology ＆ Blood Diseases Hospital，Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erlie Jiang
Phone
+86-15122538106
Email
jiangerlie@ihcmas.ac.cn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs