An observational study in Acute Leukemia and Myelodysplastic Syndromes, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Peking University People's Hospital · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 the only one that started in 2023, is one of 3 observational ones, and was the 4th 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 18–65
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 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: 55 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is below the median of 150 across 214 observational 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.
This tab as a report to print or save as PDF → With an account.
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 |
Add all 3 to your calendar (.ics) → With an account.
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.
This tab as a report to print or save as PDF → With an account.
This study is an open, prospective, single-center, single-arm study expanded based on the study of NCT03412409.The primary objective of this study is to evaluate the transplantation efficacy of the RIC conditioning regimen in elderly patients receiving the transplantation of haploidentical hematopoietic stem cells. Elderly patients are defined as ≥55 years of age; High comorbidity is defined as an HCT-CI score ≥3.Primary endpoint is 1-year LFS. Secondary endpoints are 1-year OS and 1-year TRM, Other indicators to be assessed in this study include acute GVHD, chronic GVHD, CMV activation, EBV activation, engraftment.
Currently, the transplantation of allogeneic hematopoietic stem cells (allo-SCT) remains the main and often the only cure for neoplastic hematologic disorder or hematological malignancy. Although HLA-matched siblings are the preferred donor, not all patients have one; or it needs to wait so long to obtain it that the optimal time for transplantation is past. Haploidentical transplants as secondary donors are more readily available and may be considered in combination with the conditions of the donor and the patient and the experience of the transplant facility when a matched donor is unavailable. Currently, haploidentical transplantation has been commonly applied to young patients. On the other hand, TRM rate will be higher in elderly patients and patients with high comorbidity due to tolerability, thus reducing the ultimate benefits of patients.
The choice of conditioning regimen is influenced by multiple factors such as disease type, disease status, physical condition, and source of transplant donor. For patients over 55 years of age or with a comorbidity index ≥3, the RIC regimen may be considered to improve patient tolerability. RIC regimen can improve the tolerability of patients receive transplants, while regimens such as immune suppressants are also needed to control and improve the overall transplant efficiency. An in-depth study of RIC regimen will help improve the effects of transplantation and increase patient benefits.
This study is aim to evaluate the efficacy of RIC conditioning regimen for transplantation in elderly patients or patients with high comorbidity receiving the transplantation of haploidentical hematopoietic stem cells.
Drugs and dosage of conditioning regimen:
Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(10 mg/kg,-5 to -2 days).
Supportive care:
CsA: To prevent GVHD, CsA therapy starts 9 days before transplantation at 2.5 mg/kg intravenously until gut function returns to normal after transplantation; CsA is then orally administered. MMF: To prevent GVHD, 0.5g of MMF is orally administered every 12 hours 9 days before transplantation until hematopoietic function is restored after transplantation. MTX: To prevent GVHD, MTX is intravenously administered at 15 mg/m2 on day 1 after transplantation. On days 3, 6 and 11 after transplantation, MTX is intravenously administered at 10 mg/m2. Ganciclovir: To prevent post-transplantation CMV infection, it is administered 2 days before transplantation, and to prevent post-transplantation CMV infection, it is orally administered at 400 mg twice a day until the end of all immunosuppressive medications.
Primary endpoint is 1-year LFS. Secondary endpoints are 1-year OS and 1-year TRM, Other indicators to be assessed in this study include acute GVHD, chronic GVHD, CMV activation, EBV activation, engraftment.
CMV and EBV Tests are performed twice weekly for monitor based on PCR means.
The follow-up period designed for this study is 1 year, with the day of hematopoietic stem cell transplantation as Day 1 and the visit dates of Day 0, 1st month, 2nd month, 3rd month, 6th month and 12th month. The end of the study is defined as the date of the last visit of the last patient (LPLV).
Patients ≥55 years of age and \<70 years of age, with acute leukemia or MDS (with or without HCT-CI≥3)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1-year LFS
defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.
Time frame: Participants will be followed for an expected average of 1 years
1-year OS
defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.
Time frame: Participants will be followed for an expected average of 1 years
1-year TRM
defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.
Time frame: Participants will be followed for an expected average of 1 years
Adverse event
The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation
Time frame: Participants will be followed for an expected average of 1 years
Engraftment rate
The success rate of engraftment after transplantation
Time frame: Participants will be followed for an expected average of 1 years
Plan to share: Yes
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2025, 24 months after the start.
Of 78 non-industry observational studies under Myelodysplastic Syndromes, half reached primary completion within 96 months of starting (the median), counting those still running; a quarter within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 101 studies reached it within 84 months; a quarter within 34.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University People's Hospital →