Allogeneic Hematopoietic Cell TransplantPhase 3NCT06705062
Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation
A Phase 3 study testing reduced-dose PTCy and Standard dose PTCY in people with Allogeneic Hematopoietic Cell Transplant and Graft Versus Host Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allogeneic Hematopoietic Cell Transplant, Graft Versus Host Disease
- What is being tested?
- reduced-dose PTCy and Standard dose PTCY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
- normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
- ECOG: 0-2;
- Life expectation ≥3 months;
- Informed consent provided.
Who cannot join
- Pregnancies
- active hepatitis (HBV-DNA≥1×103 copies/ml);
- active infection require anti-biotics;
- HIV infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li-ning Wang contact
China1 site, 1 recruiting
- Recruiting
Ruijin hsopital
Shanghai, Shanghai Municipality, 200025
JIong HU, 86-21-64370045 ext. 601878, hj10709@rjh.com.cn
Li-ning Wang
About this study
Official title: A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation
This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.
Read the detailed description
This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.
- Being tested
- reduced-dose PTCy, Standard dose PTCY
- Keywords
- post-transplantation cyclophosphamide, prophylaxis, reduced dose, graft versus host disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced-dose PTCyDrug
Patients receiving reduced dose of PTCy at 35mg.kg on day +3 and +4 together with tacrolimus starting from day+5 and single dose of anti-thymoglobin (ATG) 2.5mg/kg at 72 hours after documentation of neutrophil engraftment.
Standard dose PTCYDrug
Patients receiving standard dose PTCy at 50mg/kg on day +3 and +4 with tacrolimus starting from day +5 and single dose of anti-thymoglobin at 2.5mg/kg 72 hours after documentation of neutrophil engraftment.
| Study group | Role | What they receive |
|---|---|---|
| Reduced dose of post-transplantation cyclophosphamide | Experimental | study group Receives: Drug: reduced-dose PTCy |
| Standard-dose PTCy | Active comparator | Patients receiving standard dose of post-transplantation cyclophosphamide Receives: Drug: Standard dose PTCY |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-day II-IV acute GVHD
Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT
Measured: 100 day
Secondary outcomes (8)
100-day acute GVHD
Patients diagnosed with aGVHD of all grades within 100 days after allo-HSCT
Measured: 100 day
100-day non-relapse mortality
Patients died of any causes without documentation of disease relapse or progression at day 100 after allo-HSCT
Measured: 100 day
1-year chronic GVHD
Patients diagnosed with chronic GVHD of all grades at 1 year after allo-HSCT
Measured: 1 year
1-year moderate to severe chronic GVHD
Patients diagnosed with moderate to severe chronic GVHD at 1 year after allo-HSCT
Measured: 1 year
1-year NRM
Patients died of any causes without documentation of relapse or disease progression 1 year after allo-HSCT
Measured: 1 year
1-year cumulated incidence of relapse
Patients died of relapse or disease progression 1 year after allo-HSCT
Measured: 1 year
1-year overall survival
Patients remained alive at 1 year after allo-HSCT
Measured: 1 year
1-year graft host disease free and relapse free survival
Patients remained alive without relapse, grade III-IV aGVHD or moderate to severe chronic GVHD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong HU, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705062
- Sponsor's protocol ID
- PTCY-REDSTAR-2024
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06705062
- Acronym / sponsor ID
- PTCY-REDSTAR-2024
- Keywords
- post-transplantation cyclophosphamide, prophylaxis, reduced dose, graft versus host disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.
Detailed description
This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced dose of post-transplantation cyclophosphamide | Experimental | Drug: reduced-dose PTCystudy group |
| Standard-dose PTCy | Active comparator | Drug: Standard dose PTCYPatients receiving standard dose of post-transplantation cyclophosphamide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
- normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
- ECOG: 0-2;
- Life expectation ≥3 months;
- Informed consent provided.
Key exclusion criteria (4 listed)
- Pregnancies
- active hepatitis (HBV-DNA≥1×103 copies/ml);
- active infection require anti-biotics;
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduced-dose PTCyPatients receiving reduced dose of PTCy at 35mg.kg on day +3 and +4 together with tacrolimus starting from day+5 and single dose of anti-thymoglobin (ATG) 2.5mg/kg at 72 hours after documentation of neutrophil engraftment. | Drug | Reduced dose of post-transplantation cyclophosphamide |
| Standard dose PTCYPatients receiving standard dose PTCy at 50mg/kg on day +3 and +4 with tacrolimus starting from day +5 and single dose of anti-thymoglobin at 2.5mg/kg 72 hours after documentation of neutrophil engraftment. | Drug | Standard-dose PTCy |
Primary outcome
100-day II-IV acute GVHD
Time frame: 100 day
Patients diagnosed with grade II-IV acute GVHD within 100 day after allo-HSCT
8 secondary outcomes
100-day acute GVHD
Time frame: 100 day
100-day non-relapse mortality
Time frame: 100 day
1-year chronic GVHD
Time frame: 1 year
1-year moderate to severe chronic GVHD
Time frame: 1 year
1-year NRM
Time frame: 1 year
1-year cumulated incidence of relapse
Time frame: 1 year
1-year overall survival
Time frame: 1 year
1-year graft host disease free and relapse free survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-ning Wang contact
Jiong HU principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing reduced-dose PTCy and Standard dose PTCY in people with Allogeneic Hematopoietic Cell Transplant and Graft Versus Host Disease, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiong HU (86-13764313546, hj10709@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100-day II-IV acute GVHD (time frame: 100 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.