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Trial Title:
The Optimization of Haploidentical Hematopoietic Stem Cell Transplantation
NCT ID:
NCT05629260
Condition:
Hematological Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Cyclophosphamide
Conditions: Keywords:
Haploidentical Transplantation
G-CSF/ATG
PT-Cy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
ATG
Description:
Patients with intermediate-high risk hematologic malignancy who are indicated for
allogeneic hematopoietic stem cell transplantation (allo-HSCT) and absence of HLA matched
donors will be treated with haplo-HSCT, with G-CSF/ATG based protocol.
Arm group label:
G-CSF/ATG group
Intervention type:
Drug
Intervention name:
Post-transplantation cyclophosphamide
Description:
Patients with intermediate-high risk hematologic malignancy who are indicated for
allogeneic hematopoietic stem cell transplantation (allo-HSCT) and absence of HLA matched
donors will be treated with haplo-HSCT with PT-Cy based protocol.
Arm group label:
PT-Cy group
Summary:
The goal of this observational study is to compare the incidence of relapse in G-CSF/ATG
based and PT-Cy based haploidentical transplantation] in [patients aged 18 to 55 years
with a diagnosis of hematological malignancies who unmanipulated haplo-HSCT with
myeloablative conditioning]. The main question it aims to answer are:
Primary objective: To compare the incidence of relapse in G-CSF/ATG based and PT-Cy based
haploidentical transplantation and illustrate the possible immune mechanism.
Secondary objectives: To compare CMV infection, GVHD and survival outcomes, and to
observe the dynamic immune reconstitution of G-CSF/ATG based or PT-Cy based model.
Exploratory objectives: To compare the long-term quality of life among recipients who
receive G-CSF/ATG based or PT-Cy based protocol.
Criteria for eligibility:
Study pop:
Patients with hematologic malignancy who are indicated for allogeneic hematopoietic stem
cell transplantation (allo-HSCT) and absence of HLA matched donors will be treated with
haplo-HSCT with either G-CSF/ATG based or PT-Cy based protocols（4:1）
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Subjects diagnosed as acute leukemia with transplant indications in ≤ CR2;
2. Lack of available, HLA-identical, related sibling or unrelated donor;
3. Female or male, age: 18-55 years old;
4. ECOG performance status 0-2;
5. Adequate organ function as defined by the following criteria:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5× upper
limit of normal (ULN), or AST and ALT ≤5× ULN if liver function abnormalities are
due to underlying malignancy Total serum bilirubin≤1.5× ULN Serum creatinine≤2.5×
ULN
6. Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all the pertinent aspects of the
trial prior to enrollment;
7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.
Exclusion Criteria:
1. Uncontrollable active infection;
2. Severe organic impairment: hepatic and renal impairment;
3. Any of the following within 6 months prior to starting study treatment: myocardial
infarction, severe/unstable angina, congestive heart failure, or cerebrovascular
accident including transient ischemic attack;
4. Pregnancy or breastfeeding;
5. Psychiatric disorders;
6. Don't sign the informed consent;
7. Prior/concurrent clinical study experience;
8. Other conditions:
- Participant not suitable for participation, whatever the reason, as judged by
the Investigator, including medical or clinical conditions, or participants
potentially at risk of noncompliance to study procedures
- Participants are employees of the clinical study site or other individuals
directly involved in the conduct of the study, or immediate family members of
such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- Any specific situation during study implementation/course that may rise ethics
considerations
- Sensitivity to any of the study interventions, or components thereof, or drug
or other allergy that, in the opinion of the Investigator, contraindicates
participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
People's Hospital of Peking University
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengli Xu, M.D
Email:
xuzhengli0202@163.com
Contact backup:
Last name:
Xiao-Jun Huang, M.D
Investigator:
Last name:
Xiao-Jun Huang, M.D
Email:
Principal Investigator
Start date:
December 1, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Sanofi
Agency class:
Industry
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05629260
