Graft Versus Host DiseasePhase 3CY25NCT05158608
Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis
A Phase 3 study testing Post-transplantation Cyclophosphamide at dose 25 mg/kg/day and Post-transplantation Cyclophosphamide at dose 50 mg/kg/day in people with Graft Versus Host Disease and Hematologic Malignancy, run by National Research Center for Hematology, Russia.
Trial summary
This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease, Hematologic Malignancy, Cyclophosphamide Adverse Reaction
- What is being tested?
- Post-transplantation Cyclophosphamide at dose 25 mg/kg/day and Post-transplantation Cyclophosphamide at dose 50 mg/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have an indication for allogeneic hematopoietic stem cell transplantation
Who cannot join
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
- Being tested
- Post-transplantation Cyclophosphamide at dose 25 mg/kg/day, Post-transplantation Cyclophosphamide at dose 50 mg/kg/day
- Keywords
- Allogeneic transplantation, Graft-versus-host-disease prophylaxis, Post-transplant cyclophosphamide
- Medical subject headings
- Graft vs Host Disease, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-transplantation Cyclophosphamide at dose 25 mg/kg/dayDrug
Also called Endoxan, Cyphos
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
Post-transplantation Cyclophosphamide at dose 50 mg/kg/dayDrug
Also called Endoxan, Cyphos
Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5.
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day | Active comparator | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. Receives: Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/day |
| Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day | Experimental | Post-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. Receives: Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute graft-versus-host disease, grades II-IV
MAGIC criteria
Measured: 180 days
Incidence of chronic GVHD, moderate and severe (NIH criteria)
NIH criteria
Measured: 365 days
Secondary outcomes (5)
Overall survival analysis
Kaplan-Meier survival analysis
Measured: 365 days
Event-free survival analysis
Kaplan-Meier survival analysis
Measured: 365 days
Non-relapse mortality analysis
Kaplan-Meier survival analysis, competing risk analysis
Measured: 365 days
Incidence of graft failure and poor graft function
Kaplan-Meier survival analysis, competing risk analysis
Measured: 365 days
Incidence of 30-Day Readmission
Kaplan-Meier survival analysis, competing risk analysis
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Mikhail Drokov, National Research Center for Hematology, Russia
- Investigators
- Elena Parovichnikova, MD, D.Sc, Principal investigator, National Research Center for Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158608
- Sponsor's protocol ID
- CY25
- Acronym
- CY25
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center Study Comparing Cyclophosphamide at a Dose of 25 mg/kg/Day and Cyclophosphamide at a Dose of 50 mg/kg/Day in Graft Versus Host Disease Prophylaxis
- ClinicalTrials.gov ID
- NCT05158608
- Acronym / sponsor ID
- CY25 / CY25
- Keywords
- Allogeneic transplantation, Graft-versus-host-disease prophylaxis, Post-transplant cyclophosphamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 15 Dec 2021 (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 two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day | Active comparator | Drug: Post-transplantation Cyclophosphamide at dose 50 mg/kg/dayPost-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
| Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day | Experimental | Drug: Post-transplantation Cyclophosphamide at dose 25 mg/kg/dayPost-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have an indication for allogeneic hematopoietic stem cell transplantation
Key exclusion criteria (5 listed)
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
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 |
|---|---|---|
| Post-transplantation Cyclophosphamide at dose 25 mg/kg/dayAlso: Endoxan, CyphosPost-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 25 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. | Drug | Cyclophosphamide on day +3,+4 at dose 25 mg/kg/day |
| Post-transplantation Cyclophosphamide at dose 50 mg/kg/dayAlso: Endoxan, CyphosPost-transplantation Cyclophosphamide will be apply for GVHD prophylaxis on day +3,+4 at dose 50 mg/kg/day in combination with cyclosporine A at 3 mg/kg/day from day +5 and mycophenolate mofetil at dose 30-45mg/kg/day from day +5. | Drug | Cyclophosphamide on day +3,+4 at dose 50 mg/kg/day |
Primary outcome
Incidence of acute graft-versus-host disease, grades II-IV
Time frame: 180 days
MAGIC criteria
Incidence of chronic GVHD, moderate and severe (NIH criteria)
Time frame: 365 days
NIH criteria
5 secondary outcomes
Overall survival analysis
Time frame: 365 days
Event-free survival analysis
Time frame: 365 days
Non-relapse mortality analysis
Time frame: 365 days
Incidence of graft failure and poor graft function
Time frame: 365 days
Incidence of 30-Day Readmission
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Elena Parovichnikova, MD, D.Sc principal investigator
National Research Center for Hematology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Post-transplantation Cyclophosphamide at dose 25 mg/kg/day and Post-transplantation Cyclophosphamide at dose 50 mg/kg/day in people with Graft Versus Host Disease and Hematologic Malignancy, run by National Research Center for Hematology, Russia.
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 1 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 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikhail Drokov, MD, Ph.D (+74956149042, mdrokov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute graft-versus-host disease, grades II-IV (time frame: 180 days). The study lists 2 primary outcomes in all. 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 11 Jan 2022.