Graft Versus Host DiseasePhase 2NCT07319000
Efficacy of Low-dose PT-Cy for Prevention of GVHD in Ambulatory Allogeneic HSCT
A Phase 2 study testing Cyclophosphamide in people with Graft Versus Host Disease, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Low-dose post-transplant cyclophosphamide have demonstrated therapeutic efficacy in allogeneic stem cell transplants which is comparable with the standard dose and also facilitates early hematological recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Both genders.
- Diagnosis of any blood disease in need of an allogeneic bone marrow transplant (aplastic anemia, acute myeloid leukemia, chronic granulocytic leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, Hodgkin lymphoma, and Non-Hodgkin lymphoma).
- Patients who have compatible related donors to perform an identical or haploidentical allogeneic transplant.
- Patients with functional status 0 to 2 using the ECOG scale.
Who cannot join
- Poor functional status (ECOG>2).
- Organic dysfunction (Marshall score ≥2).
- Pregnancy
- Heart failure (NYHA III or IV).
- Renal failure (GFR <30 ml/min/1.72m2).
- History of ventricular arrhythmias or uncontrolled arrhythmias.
Show all 10Show fewer
- Acute myocardial infarction, unstable angina, or stable angina in the last six months.
- Uncontrolled active infection.
- Liver disease (Child-Pugh C).
- Patients not approved by the local transplant committee for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low-dose Post-transplant Cyclophosphamide for Prevention of Graft-versus-host Disease in Ambulatory Allogeneic Hematopoietic Stem Cell Transplantation
Low-dose post-transplant cyclophosphamide have demonstrated therapeutic efficacy in allogeneic stem cell transplants which is comparable with the standard dose and also facilitates early hematological recovery.
Read the detailed description
Graft-versus-host disease (GVHD) is the most important complication that occurs in hematopoietic stem cell transplantation (HSCT). GVHD prophylaxis based on the use of post-transplant cyclophosphamide (PT-Cy) has proven to be a practical, easily and accessible agent that allows both identical and haploidentical transplants to be performed with lower incidences of this disease.
Low-dose cyclophosphamide have already demonstrated therapeutic efficacy in these types of transplants which is comparable with the standard dose and also facilitates early hematological recovery that can in turn reduce risks of infection, hospital stay and total costs for the patient.
The investigators will conduct a phase 2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of of low-dose PT-Cy which is accessible to a population with limited resources while maintaining acceptable efficacy and safety to prevent GVHD.
- Conditions
- Graft Versus Host Disease
- Being tested
- Cyclophosphamide
- Keywords
- Transplants, Cyclophosphamide
- 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.
CyclophosphamideDrug
low-dose post-transplant cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Low-dose post-transplant cyclophosphamide | Experimental | Low dose post-transplant cyclophosphamide therapy will be administered as follows:
Allogeneic stem cell transplant:
Cyclophosphamide 30/mg/kg/day for 2 continuous days.
Haploidentical stem cell transplant:
Cyclophosphamide 40/mg/kg/day for 2 continuous days. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Low-dose PT-Cy
Low-dose PT-Cy (30 and 40 mg/kg/day/2 days) is effective in achieving an incidence of grade III/IV (Glucksberg grade) acute GVHD and moderate to severe chronic GVHD equal to or below historical controls of 20 and 30%, respectively.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Graft Versus Host DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A consecutive sample of 35 patients undergoing allogeneic transplantation will be included and will be administered low-dose post-transplant cyclophosphamide.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Homero Gutierrez-Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319000
- Sponsor's protocol ID
- HE22-0037
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sugita J, Kamimura T, Ishikawa T, Ota S, Eto T, Kuroha T, Miyazaki Y, Kumagai H, Matsuo K, Akashi K, Taniguchi S, Harada M, Teshima T. Reduced dose of posttransplant cyclophosphamide in HLA-haploidentical peripheral blood stem cell transplantation. Bone Marrow Transplant. 2021 Mar;56(3):596-604. doi: 10.1038/s41409-020-01065-0. Epub 2020 Sep 24.
PubMed 32973350
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-dose Post-transplant Cyclophosphamide for Prevention of Graft-versus-host Disease in Ambulatory Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07319000
- Acronym / sponsor ID
- HE22-0037
- Conditions
- Graft Versus Host Disease
- Keywords
- Transplants, Cyclophosphamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2026 (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.
Low-dose post-transplant cyclophosphamide have demonstrated therapeutic efficacy in allogeneic stem cell transplants which is comparable with the standard dose and also facilitates early hematological recovery.
Detailed description
Graft-versus-host disease (GVHD) is the most important complication that occurs in hematopoietic stem cell transplantation (HSCT). GVHD prophylaxis based on the use of post-transplant cyclophosphamide (PT-Cy) has proven to be a practical, easily and accessible agent that allows both identical and haploidentical transplants to be performed with lower incidences of this disease.
Low-dose cyclophosphamide have already demonstrated therapeutic efficacy in these types of transplants which is comparable with the standard dose and also facilitates early hematological recovery that can in turn reduce risks of infection, hospital stay and total costs for the patient.
The investigators will conduct a phase 2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of of low-dose PT-Cy which is accessible to a population with limited resources while maintaining acceptable efficacy and safety to prevent GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A consecutive sample of 35 patients undergoing allogeneic transplantation will be included and will be administered low-dose post-transplant cyclophosphamide.
| Arm | Type | Receives |
|---|---|---|
| Low-dose post-transplant cyclophosphamide | Experimental | Drug: CyclophosphamideLow dose post-transplant cyclophosphamide therapy will be administered as follows: Allogeneic stem cell transplant: Cyclophosphamide 30/mg/kg/day for 2 continuous days. Haploidentical stem cell transplant: Cyclophosphamide 40/mg/kg/day for 2 continuous days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years.
- Both genders.
- Diagnosis of any blood disease in need of an allogeneic bone marrow transplant (aplastic anemia, acute myeloid leukemia, chronic granulocytic leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia, Hodgkin lymphoma, and Non-Hodgkin lymphoma).
- Patients who have compatible related donors to perform an identical or haploidentical allogeneic transplant.
- Patients with functional status 0 to 2 using the ECOG scale.
Key exclusion criteria (10 listed)
- Poor functional status (ECOG>2).
- Organic dysfunction (Marshall score ≥2).
- Pregnancy
- Heart failure (NYHA III or IV).
- Renal failure (GFR <30 ml/min/1.72m2).
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 |
|---|---|---|
| Cyclophosphamidelow-dose post-transplant cyclophosphamide | Drug | Low-dose post-transplant cyclophosphamide |
Primary outcome
Efficacy of Low-dose PT-Cy
Time frame: 6 months
Low-dose PT-Cy (30 and 40 mg/kg/day/2 days) is effective in achieving an incidence of grade III/IV (Glucksberg grade) acute GVHD and moderate to severe chronic GVHD equal to or below historical controls of 20 and 30%, respectively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 32973350Sugita J, Kamimura T, Ishikawa T, Ota S, Eto T, Kuroha T, Miyazaki Y, Kumagai H, Matsuo K, Akashi K, Taniguchi S, Harada M, Teshima T. Reduced dose of posttransplant cyclophosphamide in HLA-haploidentical peripheral blood stem cell transplantation. Bone Marrow Transplant. 2021 Mar;56(3):596-604. doi: 10.1038/s41409-020-01065-0. Epub 2020 Sep 24.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
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 2 study testing Cyclophosphamide in people with Graft Versus Host Disease, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 10 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: finished, as of the sponsor's last update on 6 Jan 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of Low-dose PT-Cy (time frame: 6 months). 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 NCT07319000, 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 6 Jan 2026.