Graft Vs Host DiseaseNCT05780554
Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
A study testing Cyclophosphamide in people with Graft Vs Host Disease, run by Centro de Hematología y Medicina Interna at 1 site in Mexico.
Trial summary
Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft Vs Host Disease
- What is being tested?
- Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 10 Mar 2023to 20 Mar 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases).
- Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver.
Who cannot join
- Patients who refuse to sign the consent form.
- Latent infection.
- Hepatic, cardiac or bronchopulmonary symptomatic diseases
- Abnormalities on previous clinical hematological appointments, considered as contraindication.
- Positive serology for HIV, VHB, VHC
Trial locations and contacts
1 site in 1 country.
About this study
Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood.
In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.
- Conditions
- Graft Vs Host Disease
- Being tested
- 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
Post transplant cyclophosphamide 25 mg/kg on day +3 and +4
CyclophosphamideDrug
Post transplant cyclophosphamide 50 mg/kg on day +3 and +4
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide 50 mg/kg | Active comparator | Not described Receives: Drug: Cyclophosphamide |
| Cyclophosphamide 25 mg/kg | Experimental | Not described Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute GVHD rate
Incidence of acute GVHD after HSCT
Measured: 6 months
Chronic GVHD rate
Incidence of chronic GVHD after HSCT
Measured: 18 months
Relapse free survival
Incidence of relapse of the disease after HSCT
Measured: 12 months
Overall survival
Patients survival after therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start10 Mar 2023
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
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 Vs 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Hematología y Medicina Interna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo J. RUIZ-ARGÜELLES, Centro de Hematología y Medicina Interna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780554
- Sponsor's protocol ID
- CHMI-020323-1
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olivares-Gazca JC, Pastelin-Martinez ML, Montes-Robles MA, Gallardo-Perez MM, Hernandez-Flores EJ, Robles-Nasta M, Sanchez-Bonilla D, Ruiz-Delgado GJ, Ruiz-Arguelles GJ. Can doses of post-transplantation cyclophosphamide in haploidentical stem cell allografts be reduced? Hematology. 2023 Dec;28(1):2242176. doi: 10.1080/16078454.2023.2242176.
PubMed 37530697
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplantation Cyclophosphamide in Haploidentical Stem Cell Allografts Dose Reduction: 50 mg/kg vs 25 mg/kg
- ClinicalTrials.gov ID
- NCT05780554
- Acronym / sponsor ID
- CHMI-020323-1
- Conditions
- Graft Vs Host Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centro de Hematología y Medicina InternaUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 22 Mar 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.
Allogeneic hematopoietic cell transplantation (HSCT) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an HLA-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. This problem has led to an expansion of the donor pool to include alternative donor sources such as HLA-haploidentical (Haplo) relatives, HLA-mismatched unrelated donors, and HLA-matched or mismatched cord blood.
In the Hematology and Internal Medicine Center of Clinica Ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/Kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/Kg doses. Haplo-HSCT can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. Outpatient-based Haplo-HSCT has turned into the solution of the HSCT most frequent problems in low- and middle-income countries (LMIC): Cost and donor availability. The high dose administration of PT-Cy after transplant can lead into hematological and cardiac, toxicities. There is preliminary information about diminished doses of PTCy, might being equally effective in the prevention of GVHD and substantially less toxic.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide 50 mg/kg | Active comparator | Drug: Cyclophosphamide |
| Cyclophosphamide 25 mg/kg | Experimental | Drug: Cyclophosphamide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates to receive a Haplo-HSCT (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases).
- Patients able to travel to and remain in Puebla, México during a 4-week period, accompanied by a caregiver.
Key exclusion criteria (5 listed)
- Patients who refuse to sign the consent form.
- Latent infection.
- Hepatic, cardiac or bronchopulmonary symptomatic diseases
- Abnormalities on previous clinical hematological appointments, considered as contraindication.
- Positive serology for HIV, VHB, VHC
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 |
|---|---|---|
| CyclophosphamidePost transplant cyclophosphamide 25 mg/kg on day +3 and +4 | Drug | Cyclophosphamide 25 mg/kg |
| CyclophosphamidePost transplant cyclophosphamide 50 mg/kg on day +3 and +4 | Drug | Cyclophosphamide 50 mg/kg |
Primary outcome
Acute GVHD rate
Time frame: 6 months
Incidence of acute GVHD after HSCT
Chronic GVHD rate
Time frame: 18 months
Incidence of chronic GVHD after HSCT
Relapse free survival
Time frame: 12 months
Incidence of relapse of the disease after HSCT
Overall survival
Time frame: 12 months
Patients survival after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 37530697Olivares-Gazca JC, Pastelin-Martinez ML, Montes-Robles MA, Gallardo-Perez MM, Hernandez-Flores EJ, Robles-Nasta M, Sanchez-Bonilla D, Ruiz-Delgado GJ, Ruiz-Arguelles GJ. Can doses of post-transplantation cyclophosphamide in haploidentical stem cell allografts be reduced? Hematology. 2023 Dec;28(1):2242176. doi: 10.1080/16078454.2023.2242176.
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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 study testing Cyclophosphamide in people with Graft Vs Host Disease, run by Centro de Hematología y Medicina Interna 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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.
Are results available for this study?
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?
Acute GVHD rate (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05780554, 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 23 Mar 2023.