Hematologic MalignanciesPhase 2NCT07359859
A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
A Phase 2 study testing Cyclophosphamide, Mycophenolate Mofetil and Ruxolitinib in people with Hematologic Malignancies, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Cyclophosphamide, Mycophenolate Mofetil and Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jan 2026to Jan 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18- years-old at time of consent
- Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
- Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky score ≥ 70%
- Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
- °Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: Intrauterine device (IUD) plus one barrier method Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or A vasectomized partner.
- For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
Who cannot join
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
- Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
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- Uncontrolled psychiatric illness
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brian Shaffer, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Doris Ponce, MD, 646-608-3739
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Doris Ponce, MD, 646-608-3739
About this study
Official title: Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
- Conditions
- Hematologic Malignancies
- Being tested
- Cyclophosphamide, Mycophenolate Mofetil, Ruxolitinib, Tacrolimus
- Keywords
- graft-versus-host disease (GVHD), allogeneic hematopoietic stem cell transplant (allo-HCT)
- Medical subject headings
- Hematologic Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
An intermediate dose (medium dose) of Post-transplant Cyclophosphamide
CyclophosphamideDrug
A full dose of Post-transplant Cyclophosphamide
Also called MMF
Day +5 to +35
RuxolitinibDrug
twice a day
TacrolimusDrug
Day +5, taper per SoC
TacrolimusDrug
Day +5, taper initiation within 2 weeks of starting Ruxolitinib
| Study group | Role | What they receive |
|---|---|---|
| An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib | Experimental | will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib Receives: Drug: Cyclophosphamide; Drug: Mycophenolate Mofetil; Drug: Ruxolitinib; Drug: Tacrolimus |
| A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) | Active comparator | will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) Receives: Drug: Cyclophosphamide; Drug: Mycophenolate Mofetil; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess cGVHD-free survival
Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.
Measured: 1 year post-HCT
Secondary outcomes (1)
incidence of grade 2-4 infections.
Grade 2-4 infections by CTCAE v5 either clinically or microbiologically will be assessed throughout the study until day +365. Causality and relationship with ruxolitinib will be determined.
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 posted22 Jan 2026
- Study start20 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Doris Ponce, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359859
- Sponsor's protocol ID
- 25-212
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY
- ClinicalTrials.gov ID
- NCT07359859
- Acronym / sponsor ID
- 25-212
- Conditions
- Hematologic Malignancies
- Keywords
- graft-versus-host disease (GVHD), allogeneic hematopoietic stem cell transplant (allo-HCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 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.
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib | Experimental | Drug: Cyclophosphamide, Drug: Mycophenolate Mofetil, Drug: Ruxolitinib, Drug: Tacrolimuswill receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib |
| A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) | Active comparator | Drug: Cyclophosphamide, Drug: Mycophenolate Mofetil, Drug: Tacrolimuswill receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥18- years-old at time of consent
- Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
- Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky score ≥ 70%
- Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
Key exclusion criteria (9 listed)
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
- Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
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 |
|---|---|---|
| CyclophosphamideAn intermediate dose (medium dose) of Post-transplant Cyclophosphamide | Drug | An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib |
| CyclophosphamideA full dose of Post-transplant Cyclophosphamide | Drug | A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) |
| Mycophenolate MofetilAlso: MMFDay +5 to +35 | Drug | A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach), An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib |
| Ruxolitinibtwice a day | Drug | An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib |
| TacrolimusDay +5, taper per SoC | Drug | A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach) |
| TacrolimusDay +5, taper initiation within 2 weeks of starting Ruxolitinib | Drug | An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib |
Primary outcome
assess cGVHD-free survival
Time frame: 1 year post-HCT
Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.
1 secondary outcome
incidence of grade 2-4 infections.
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 7 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Brian Shaffer, MD contact
Doris Ponce, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
7 sites 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, Mycophenolate Mofetil and Ruxolitinib in people with Hematologic Malignancies, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 7 inclusion and 9 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
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 Doris Ponce, MD, MS (646-608-3739, BMTTrials@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess cGVHD-free survival (time frame: 1 year post-HCT). 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 7 Jul 2026.