Age-Stratified Conditioning Regimen Efficacy for MDS Haplo-HSCT
ConditionMyelodysplastic Syndromes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital
About this trial
This study plan aims to enroll adult patients diagnosed with myelodysplastic syndrome (MDS) who are scheduled to receive T-cell-replete haploidentical hematopoietic stem cell transplantation. After obtaining written informed consent, participants will receive either reduced-toxicity Bu/Flu/Cy/ATG conditioning regimen (for patients aged ≥55 years) or standard myeloablative modified Bu/Cy+ATG conditioning regimen (for patients aged \<55 years) followed by unified post-transplant immunosuppression and supportive care. The objective is to prospectively characterize the 1-year transplant-related mortality and comprehensively evaluate hematopoietic engraftment, graft-versus-host disease, infection, relapse, survival outcomes and conditioning-related organ toxicity among all enrolled patients undergoing haploidentical transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation
Disqualifiers
Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure
Trial design
Design model
Single group
Treatments tested in this trial
RTC conditioning regimen and Modified Bu/Cy conditioning regimen
DrugRTC preconditioning regimen consisted of cytarabine (2g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m2/day, days -6 to -2), semustine (250 mg/m2, day-3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France). Bu/Cy preconditioning regimen consisted of tandard institutional myeloablative busulfan + cyclophosphamide + rabbit ATG regimen per department routine dosing guidelines.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Age-Stratified Conditioning RegimenOther 1 intervention
Trial outcomes
Primary outcomes
1
transplant-related mortality (TRM)
Death without disease progression or relapse
Time frame
Participants will be followed for an expected average of 1 yearsSecondary outcomes
1
Hematopoietic engraftment
Neutrophil engraftment is defined as the first day of sustained absolute neutrophil count (ANC) ≥0.5×10⁹/L for 3 consecutive days; platelet engraftment is defined as the first day of sustained platelet count (PLT) ≥20×10⁹/L without transfusion support for 7 consecutive days. Cumulative incidence of neutrophil engraftment at Day 30 and platelet engraftment at Day 90 will be calculated.
Time frame
Day 30 and Day 90 post-transplantation2
Cumulative incidence of graft-versus-host disease (GVHD)
Cumulative incidence of Grade II-IV and Grade III-IV acute GVHD at Day 100, as well as chronic GVHD and moderate-severe chronic GVHD within 3 years after transplantation, graded per Seattle criteria.
Time frame
Day 100 and 3 years after transplantation3
Cumulative incidence of CMV and EBV reactivation
Defined as any detectable CMV or EBV viral load elevation requiring clinical intervention within 1 year after transplantation.
Time frame
1 year after transplantation4
Cumulative incidence of hematologic relapse
Defined as bone marrow blast recurrence or extramedullary disease relapse within 1 year after transplantation.
Time frame
1 year after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: