A Phase 1/2 interventional study of Sirolimus and Ruxolitinib in Acute Leukemia, Myelodysplastic Syndromes and Severe Aplastic Anemia (SAA), sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Peking University People's Hospital · Phase 1/2, Interventional, and Prevention
Among 16 studies testing sirolimus in Myelodysplastic Syndromes — 3 open to participants now, 4 under way, none of them phase 3. Sirolimus · Myelodysplastic Syndromes.
Among the 16 studies testing sirolimus in Myelodysplastic Syndromes, this one is the 6th largest by planned enrollment of the 15 interventional ones, is the only one that started in 2026, is one of 4 in phase 1/2, and was the 16th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →3 of the 16 studies testing sirolimus in Myelodysplastic Syndromes are open now, in 1 country. Each count lists the studies.
Sirolimus: first FDA approval 1999 (RAPAMUNE), first EMA approval 2001. What it is approved for, and how studies give it, is on its page →
Of the 262 Myelodysplastic Syndromes studies recruiting now, 165 (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: 14 Years and older · all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2026.
Median enrollment 30 across the 15 interventional studies. Of the 11 that completed or were terminated, 6 (55%) have results posted.
None of the 16 has an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
12 studies in Myelodysplastic Syndromes by Peking University People's Hospital: 10 open now, 10 under way, none of them phase 3.
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 2 in phase 1/2, and was the 12th registered.
Peking University People's Hospital’s Myelodysplastic Syndromes studies by the year they started, since 2013.
2 of the studies testing sirolimus in Myelodysplastic Syndromes that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04888741University of BirminghamMethods of T Cell Depletion Trial (MoTD) | 2027-08-23 |
| 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 |
Among the 16 studies testing sirolimus in Myelodysplastic Syndromes, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Peking University People's Hospital’s 12 in Myelodysplastic Syndromes:
Nothing recorded among them since 2026-09-25.
Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Ruxolitinib and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Ruxolitinib+MMF+ATG (SRMA) for prophylaxis of aGVHD
Drug: Sirolimus · Drug: Ruxolitinib · Drug: MMF · Drug: ATG
Sirolimus 2mg once daily, maintaining the concentration at 5-10 ng/ml. Gradually reduce the dosage after +100 days. If the patient has stable engraftment and no GVHD, discontinue on +180 days.
Ruxolitinib is administered at a dose of 5mg twice daily from the start of the study until +90 days. The dose is reduced to 5mg once daily on +90 days, and discontinued on +120 days.
MMF 0.5g, taken twice daily, is discontinued after 60 days. If it is resumed after 60 days, it should be taken for 2 weeks.
2.5 mg/kg, from -5d to -2d
Incidence of Grade 2-4 aGVHD within 100 days post transplantation
Time frame: Participants will be followed for an expected average of 100 days post transplantation
Incidence of chronic GVHD (cGVHD) within 1 year post transplantation
Time frame: Participants will be followed for an expected average of 1 year
Incidence of thrombotic microangiopathy within 1 year post transplantation
Time frame: Participants will be followed for an expected average of 1 year
Cumulative incidence of relapse
Time frame: Participants will be followed for an expected average of 1 year
Transplant-related mortality
Time frame: Participants will be followed for an expected average of 1 year
Overall survival
Time frame: Participants will be followed for an expected average of 1 year
Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV)
Time frame: Participants will be followed for an expected average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sirolimus · Ruxolitinib
Peking University People's Hospital →