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Trial Title:
ATG Plus Low-dose PT-Cy for GVHD Prevention
NCT ID:
NCT06108739
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Cyclophosphamide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamid
Description:
A total of 10mg/kg ATG was administered, and two doses of 14.5 mg/kg Cy were given on
days 3 and 4 post-HCT in ATG-PTCy cohort.
Arm group label:
ATG-PTCy cohort
Intervention type:
Drug
Intervention name:
ATG
Description:
A total of 10mg/kg ATG was administered.
Arm group label:
ATG cohort
Arm group label:
ATG-PTCy cohort
Summary:
During the past decades, the wider application of easily available haploidentical donor
hematopoietic cell transplant (haplo-HCT) has been made possible through the T
cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin
(ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide
(PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes
in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce
graft versus host disease (GVHD) and mortality associated with severe forms of GVHD.
Recently, investigators established a regimen using low-dose PTCy in conjunction with
standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and
disease relapse.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first
allogeneic hematopoietic stem cell transplantation;
2. Male or female , aged 12-55 years;
3. Haploidentical donor transplantation;
4. ECOG score ≤3; The basic organ function tests met the following standards;
1) Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
Exclusion Criteria:
1. Severe brain, heart, kidney or liver dysfunction;
2. Refractory malignant state;
3. Patients with other malignant tumors requiring treatment;
4. Clinically uncontrolled severe active infection;
5. The expected survival time was less than 3 months.
6. A history of severe anaphylaxis.
7. Pregnant or lactating women;
8. Any condition considered by the investigators to be unsuitable for enrollment.
Gender:
All
Minimum age:
12 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Wang
Start date:
November 1, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
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/NCT06108739
