A Phase 2 interventional study of RTC conditioning regimen and Modified Bu/Cy conditioning regimen in Myelodysplastic Syndromes, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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Among 12 studies in Myelodysplastic Syndromes by Peking University People's Hospital — 10 open to participants now, 10 under way, none of them phase 3. Myelodysplastic Syndromes · Peking University People's Hospital.
Among the 12 studies in Myelodysplastic Syndromes by Peking University People's Hospital, this one is one of 4 that started in 2026, is one of 6 in phase 2, and was the 11th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →10 of the 12 studies in Myelodysplastic Syndromes by Peking University People's Hospital are open now, in 1 country. Recruiting first, the newest first:
Peking University People's Hospital · Sites in China
Ages 12–65
Peking University People's Hospital · Sites in China
Ages 15–70
Peking University People's Hospital · Sites in China
Ages 12–65
Peking University People's Hospital · Sites in China
Ages 55–70
Peking University People's Hospital · Sites in China
Ages 18–70
By country, each count listing its studies:
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8
First in 2013; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 50 across the 9 interventional studies, 120 across the 3 observational. None of them has completed or been terminated yet.
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Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
3 of the studies in Myelodysplastic Syndromes by Peking University People's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07449286Peking University People's HospitalIFN-α in Relapse Prevention. | 2026-12-31 |
| NCT07319793Peking University People's HospitalPre-DLI or Pro-DLI in Relapsed/Refractory Myeloid Neoplasms After HSCT | 2027-01-01 |
| NCT07796620Peking University People's HospitalSirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI | 2027-09-30 |
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Among the 12 studies in Myelodysplastic Syndromes by Peking University People's Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
MDS patients without identical sibling donor or unrelated donor would receive haplo-HSCT. 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.
Drug: RTC conditioning regimen and Modified Bu/Cy conditioning regimen
RTC 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.
transplant-related mortality (TRM)
Death without disease progression or relapse
Time frame: Participants will be followed for an expected average of 1 years
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-transplantation
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 transplantation
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 transplantation
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 transplantation
Disease-free survival (DFS)
Defined as the time from transplantation until hematologic relapse or death from any cause.
Time frame: 1 year after transplantation
Overall survival（OS）
Defined as the time from treatment until death from any cause or the last follow-up.
Time frame: 1 year after transplantation
Conditioning-related organ toxicities
Incidence of grade 1-4 cardiac, renal, hepatic, gastrointestinal and oral mucosal toxicities from conditioning initiation to Day +30 post-transplantation, with separate analysis of Grade 3-4 severe organ injury, hepatic veno-occlusive disease (VOD), and conditioning-related death, graded per WHO organ toxicity scale.
Time frame: From conditioning start to Day 30 post-transplantation
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
Of 227 non-industry phase 2 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 116. This study's planned 17 months is below that.
Counting every sponsor, half of 279 studies reached it within 66 months; a quarter within 40 and three quarters within 104.
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