Hematologic MalignancyPhase 3NCT06108739
ATG Plus Low-dose PT-Cy for GVHD Prevention
A Phase 3 study testing Cyclophosphamid and ATG in people with Hematologic Malignancy, run by Peking University People's Hospital at 1 site in China.
Trial summary
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and… Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Cyclophosphamid and ATG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
- Male or female , aged 12-55 years;
- Haploidentical donor transplantation;
- ECOG score ≤3; The basic organ function tests met the following standards;
- 1) Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
Who cannot join
- Severe brain, heart, kidney or liver dysfunction;
- Refractory malignant state;
- Patients with other malignant tumors requiring treatment;
- Clinically uncontrolled severe active infection;
- The expected survival time was less than 3 months.
- A history of severe anaphylaxis.
- Pregnant or lactating women;
- Any condition considered by the investigators to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.
- Conditions
- Hematologic Malignancy
- Being tested
- Cyclophosphamid, ATG
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamidDrug
A total of 10mg/kg ATG was administered, and two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.
ATGDrug
A total of 10mg/kg ATG was administered.
| Study group | Role | What they receive |
|---|---|---|
| ATG-PTCy cohort | Experimental | The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort. Receives: Drug: Cyclophosphamid; Drug: ATG |
| ATG cohort | Active comparator | The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered. Receives: Drug: ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute graft versus host disease.
The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.
Measured: 100 days post HSCT.
Secondary outcomes (9)
Engraftment
Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5≥10^9/L.
Measured: 30 days post HSCT.
The incidence of chronic GvHD
The incidence of chronic GvHD.
Measured: 1 year post HSCT.
The incidence of non-relapse mortality
The incidence of non-relapse mortality
Measured: 1 year post HSCT.
The incidence of infection
The incidence of infection
Measured: 1 year post HSCT.
The incidence of relapse
The incidence of relapse
Measured: 1 year post HSCT.
Overall survival
Overall survival
Measured: 1 year post HSCT.
Disease free survival
Disease free survival
Measured: 1 year post HSCT.
GvHD relapse free survival
GvHD relapse free survival
Measured: 1 year post HSCT.
Immune reconstitution
Immune reconstitution was evaluated at 1, 2, 3, 6, 9 and 12 months by analysis of peripheral blood MNCs detecting CD3, CD4, CD19 and immunoglobulin (Ig) A, G and M levels.
Measured: 1 year post HSCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108739
- Sponsor's protocol ID
- ATG plus PT-Cy in haplo-SCT
- Status last verified
- Aug 2024
- First submitted
- 22 Oct 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu ZL, Han TT, Zhu XL, Liu J, Lv M, Sun YQ, Mo XD, Cheng YF, Xu LP, Zhang XH, Huang XJ, Wang Y. Randomized trial of anti-thymocyte globulin plus lowdose post-transplant cyclophosphamide to prevent graft-versus- host disease in haploidentical transplantation. Haematologica. 2025 Dec 1;110(12):2965-2973. doi: 10.3324/haematol.2025.287504. Epub 2025 Jun 19.
PubMed 40534493
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT
- ClinicalTrials.gov ID
- NCT06108739
- Acronym / sponsor ID
- ATG plus PT-Cy in haplo-SCT
- Conditions
- Hematologic Malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Oct 2023 (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.
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG-PTCy cohort | Experimental | Drug: Cyclophosphamid, Drug: ATGThe conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort. |
| ATG cohort | Active comparator | Drug: ATGThe conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
- Male or female , aged 12-55 years;
- Haploidentical donor transplantation;
- ECOG score ≤3; The basic organ function tests met the following standards;
- 1) Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
Key exclusion criteria (8 listed)
- Severe brain, heart, kidney or liver dysfunction;
- Refractory malignant state;
- Patients with other malignant tumors requiring treatment;
- Clinically uncontrolled severe active infection;
- The expected survival time was less than 3 months.
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 |
|---|---|---|
| CyclophosphamidA total of 10mg/kg ATG was administered, and two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort. | Drug | ATG-PTCy cohort |
| ATGA total of 10mg/kg ATG was administered. | Drug | ATG cohort, ATG-PTCy cohort |
Primary outcome
The incidence of acute graft versus host disease.
Time frame: 100 days post HSCT.
The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.
9 secondary outcomes
Engraftment
Time frame: 30 days post HSCT.
The incidence of chronic GvHD
Time frame: 1 year post HSCT.
The incidence of non-relapse mortality
Time frame: 1 year post HSCT.
The incidence of infection
Time frame: 1 year post HSCT.
The incidence of relapse
Time frame: 1 year post HSCT.
Overall survival
Time frame: 1 year post HSCT.
Disease free survival
Time frame: 1 year post HSCT.
GvHD relapse free survival
Time frame: 1 year post HSCT.
Immune reconstitution
Time frame: 1 year post HSCT.
Results and safety
The study was stopped early (reason given: DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 40534493Xu ZL, Han TT, Zhu XL, Liu J, Lv M, Sun YQ, Mo XD, Cheng YF, Xu LP, Zhang XH, Huang XJ, Wang Y. Randomized trial of anti-thymocyte globulin plus lowdose post-transplant cyclophosphamide to prevent graft-versus- host disease in haploidentical transplantation. Haematologica. 2025 Dec 1;110(12):2965-2973. doi: 10.3324/haematol.2025.287504. Epub 2025 Jun 19.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cyclophosphamid and ATG in people with Hematologic Malignancy, run by Peking University People's Hospital 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 8 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: stopped early, as of the sponsor's last update on 3 Jun 2025. 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?
The study was stopped early (reason given: DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute graft versus host disease. (time frame: 100 days post HSCT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108739, which also lists 1 linked publication.
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 3 Jun 2025; AzTrials last refreshed its copy on 4 Nov 2026.