Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia
August 9, 2022 updated by: Institute of Hematology & Blood Diseases Hospital
The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
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
Study Overview
Status
Recruiting
Conditions
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 Type
Interventional
Enrollment (Anticipated)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300041
- Recruiting
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Erlie Jiang
- Phone Number: +86-15122538106
- Email: jiangerlie@ihcmas.ac.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Haplo-HSCT group
58 patients will be involved in this group
|
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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 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
|
12 months
|
|
Disease free survival
Time Frame: 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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative relapse incidence
Time Frame: 12 months
|
Defined as the cumulative incidence of relapse after the day of transplantation
|
12 months
|
|
Cumulative incidence of engraftment
Time Frame: 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
|
12 months
|
|
cumulative incidence of acute graft-versus-host disease(GVHD)
Time Frame: 12 months
|
Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria
|
12 months
|
|
cumulative incidence of chronic GVHD at one year
Time Frame: 12 months
|
chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)
|
12 months
|
|
Cumulative Incidence of Infectious Complications
Time Frame: 12 months
|
Defined as cumulative incidence of viral, fungal and bacterial infections
|
12 months
|
|
Cumulative Incidence of hemorrhagic cystitis
Time Frame: 12 months
|
Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation
|
12 months
|
|
Cumulative Incidence of lymphoproliferative disease
Time Frame: 12 months
|
Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Anticipated)
November 1, 2023
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
April 12, 2022
First Submitted That Met QC Criteria
April 12, 2022
First Posted (Actual)
April 19, 2022
Study Record Updates
Last Update Posted (Actual)
August 11, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220410
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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