LeukemiaPhase 2NCT07249346
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
A Phase 2 study testing Ruxolitinib, Myeloablative conditioning regimen and Hematopoietic Stem Cell Transplantation in people with Leukemia and Myelodysplasia, run by Hannah Choe, MD at 3 sites in United States.
Trial summary
This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelodysplasia, Chronic Myelomonocytic Leukemia
- What is being tested?
- Ruxolitinib, Myeloablative conditioning regimen and Hematopoietic Stem Cell Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jan 2026to 1 Jun 2027
- 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
- Age 18.0 years or older at the time of enrollment
- Patients undergoing allogeneic hematopoietic cell transplantation for one of the following indications:
- Acute leukemia with no circulating blasts and with less than 5% blasts in the bone marrow
- Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with <5% versus 5-10% blasts in this disease).
- Planned myeloablative (MAC) conditioning regimen (see eligible regimens in Section 9.2)
- Patients must have a related or unrelated peripheral blood stem cell donor as follows:
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- Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
- Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing.
- Unrelated donor must be willing to donate peripheral blood stem cells and meet National Marrow Donor Program (NMDP) criteria for donation.
- Donor selection must comply with 21 CFR 1271
- Cardiac function: Left ventricular ejection fraction at least 45%
- Estimated creatinine clearance greater than 60 ml/min (C-G formula)
- Pulmonary function: DLCO (diffusing capacity of lung for carbon monoxide) corrected for hemoglobin at least 60% and FEV1 (forced expiratory volume at one second) predicted at least 60%
- Liver function: AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) <3x Upper Limit of Normal (ULN); Total bilirubin <2 mg/dL excluding Gilbert's syndrome or hemolysis
- Karnofsky Performance Score at least 70%.
- Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant.
- Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.
- Plans for the use of targeted small molecule inhibitor post-transplant maintenance therapy must be disclosed upon enrollment. Planned use of investigational maintenance agents is not permitted. Planned hypomethylating agents as maintenance therapy is not permitted.
- Allowed maintenance includes:
- FLT3 inhibitors: gilteritinib, sorafenib, midostaurin
- IDH inhibitors: enasidenib, ivosidenib
- BCR/ABL inhibitors: imatinib, ponatinib, dasatinib, nilotinib
- Other targeted therapies may be discussed with protocol chairsVoluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- There are no restrictions based on blood counts as this intervention is being used in combination with intensive chemotherapy with intent to myeloablate.
Who cannot join
- Prior allogeneic transplant
- Active CNS (central nervous system) involvement by malignant cells
- Patients with secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes, including CMML(chronic myelomonocytic leukemia) and MDS/MPN (myelodysplastic syndromes/myeloproliferative neoplasms) syndromes; patients with secondary acute myeloid leukemia arising from myelodysplastic neoplasm are eligible.
- Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
- Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., TB).
- Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible.
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- Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV). The study allows:
- Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis to prevent potential HBV reactivation.
- Positive HCV serology with quantitative PCR (polymerase chain reaction) for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment.
- Arterial or venous thrombosis including DVT (deep vein thrombois), PE (pulmonary embolism), stroke, and myocardial infarction within six (6) months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia. Catheter-associated DVT is not exclusionary.
- Female patients who are pregnant or lactating
- Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the Protocol Officer or Chairs, qualifying as below.
- the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or
- the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up
- the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin
- Planned use of ATG or alemtuzumab in conditioning regimen
- Planned use of prophylactic donor leukocyte infusions
- Prior use of ruxolitinib
- Prior use of immune checkpoint inhibitors (i.e., PD1, PDL1, CTLA4 modulators) within six (6) months prior to conditioning
- History of congenital Long QT syndrome
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States3 sites, 3 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tiffany Hill, BSN, RN, (205) 644-2590, tiffanydhill@uabmc.edu
Omer Jamy, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02144
Yi-Bin Chen, MD, (617) 726-2000, ychen6@mgb.org
Sheila Connolly, RN, BSN, (617) 314-1334, shconnolly@mgh.harvard.edu
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Hannah K Choe, MD, Hannah.Choe@osumc.edu
Hannah K Choe, MD
About this study
Official title: An Open Label, Non-Randomized, Multi-Center Pilot Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for GVHD Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).
Read the detailed description
Primary Objective:
To assess survival without severe Grade 3-4 acute GVHD at Day 180 post-transplant in patients treated with GVHD prophylaxis in myeloablative allogeneic hematopoietic stem cell transplantation for patients treated with low dose PTCy(Cyclophosphamide)/Tac(Tacrolimus)/Rux(Ruxolitinib).
Secondary Objectives:
To describe rates of Grade II-IV and Grades III-IV acute GVHD, chronic GVHD requiring immunosuppression, hematologic recovery (neutrophil and platelet), disease relapse or progression, rates of Grade 3+ toxicity, primary and secondary graft failure, and overall survival (OS) for patients treated with low dose PTCy/Tac/Rux.
- Conditions
- Leukemia, Myelodysplasia, Chronic Myelomonocytic Leukemia
- Being tested
- Ruxolitinib, Myeloablative conditioning regimen, Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Tacrolimus
- Medical subject headings
- Leukemia, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Taken PO
Myeloablative conditioning regimenDrug
Patients will receive a full-intensity myeloablative conditioning regimen. Allowed regimens include:
- Flu/Bu(130 mg/m2/day x 4 days)
- Flu/TBI (8-12Gy)
- Flu/Bu/Thiotepa The addition of alemtuzumab or ATG is not allowed.
Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called HCT
Patients will undergo HCT
CyclophosphamideDrug
Given IV
TacrolimusDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Feasibility) | Experimental | Patients will receive post-transplant cyclophosphamide 25 mg/kg on Days +3 and +4, tacrolimus, and ruxolitinib for GVHD prophylaxis. Ruxolitinib will be dosed as ruxolitinib IR 5 mg po qD (on fluconazole, 5 mg po BID not on fluconazole) starting Day -1 until Day +28 and neutrophil engraftment and then increase to ruxolitinib IR 5 mg po BID (on fluconazole,10 mg po BID not on fluconazole) for up to 12 months. Tacrolimus will be tapered after Day +90 per institutional guidelines.
Patients will receive ruxolitinib up to Day 180 posttransplant. Ruxolitinib will be tapered over 2-3 months depending on the starting dose at time of taper. Receives: Drug: Ruxolitinib; Drug: Myeloablative conditioning regimen; Procedure: Hematopoietic Stem Cell Transplantation; Drug: Cyclophosphamide; Drug: Tacrolimus |
| Cohort 2 (dose expansion) | Experimental | Patients will receive post-transplant cyclophosphamide 25 mg/kg on Days +3 and +4, tacrolimus, and ruxolitinib for GVHD prophylaxis. Ruxolitinib will be dosed as ruxolitinib IR 5 mg po qD (on fluconazole, 5 mg po BID not on fluconazole) starting Day -1 until Day +28 and neutrophil engraftment and then increase to ruxolitinib IR 5 mg po BID (on fluconazole,10 mg po BID not on fluconazole) for up to 12 months. Tacrolimus will be tapered after Day +90 per institutional guidelines.
Patients will receive ruxolitinib up to Day 365 post-transplant. Ruxolitinib will be tapered over 2-3 months depending on the starting dose at time of taper. Receives: Drug: Ruxolitinib; Drug: Myeloablative conditioning regimen; Procedure: Hematopoietic Stem Cell Transplantation; Drug: Cyclophosphamide; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe acute GVHD-free Survival (SGFS)
SGFS will be calculated from the time of transplant to onset of grade 3-4 acute GVHD or death censoring patients alive without grade 3-4 GVHD at last clinical assessment date. The SGFS rate together with 95% confidence interval at day 180 will be estimated by Kaplan-Meier method.
Measured: At day 180 post-transplant
Secondary outcomes (11)
GVHD, relapse free survival (GRFS)
GVHD-free, relapse-free survival as a time to event outcome is defined as Grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, underlying disease relapse or progression, or death by any cause.
Measured: At 6 months and 1 year
Grade II-IV acute GVHD and Grade III-IV acute GVHD
Cumulative incidences of Grade II-IV and III-IV acute GVHD will be determined. Acute GVHD will be graded according to standard MAGIC criteria. The time of onset of acute Grades II-IV and III-IV acute GVHD will be recorded, as well as the maximum grade achieved. Within the participants experiencing Grade II-IV acute GVHD, the proportion of patients with visceral involvement (liver or gut) will be described. Cumulative incidences of Minnesota standard and high risk acute GVHD will also be determined.
Measured: At 6 months
Chronic GVHD requiring immunosuppression
Rate of chronic GVHD requiring immunosupression at 1 year
Measured: At 1 year
GVHD Free Survival (GFS)
Events for this time to event outcome is defined as any of the following: 1) Grade III-IV acute GVHD, 2) chronic GVHD requiring systemic immune suppression, or 3) death by any cause. The time to the event is defined as the time to the earliest of the qualifying events. Subjects alive without experiencing an event will be censored at last available GVHD assessment
Measured: At 1 year
Hematologic Recovery (Neutrophil Counts)
Hematologic recovery will be assessed according to neutrophil and platelet counts recovery after transplant. Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death or subsequent transplant without neutrophil recovery. For patients who never drop ANC below 500/mm3, the date of neutrophil recovery will be Day +1 post-transplant.
Measured: Up to 2 years post transplant
Disease Relapse or Progression
Number of patients with disease relapse or progression. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features.
Relapse will be diagnosed when there is:
- Reappearance of leukemia blast cells in the peripheral blood; or,
- Greater than 5% blasts in the bone marrow, not attributable to another cause (e.g., bone marrow regeneration); or, Page 56 of 63
- The appearance of previous or new dysplastic changes (MDS specific) within the bone marrow with falling donor chimerism; or,
- The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid or,
- The reappearance of cytogenetic abnormalities present prior to transplantation
Measured: At 1 year
Non-relapse Mortality (NRM)
The cumulative incidence of NRM will be estimated after hematopoietic cell transplantation (HCT). An event for this endpoint is death without evidence of disease progression or recurrence. Disease progression or recurrence will be considered competing events.
Measured: At 1 year
Grade 3+ Toxicities
Adverse events and toxicities will be summarized using the NCI CTCAE v5.0. The person-year rates of Grade 3+ toxicity, grade 2-3 infections will be calculated with 95% CI.
Measured: Up to 2 years post transplant
Disease-Free Survival (DFS)
Disease-free survival is the time from date of transplant to death or relapse/progression, whichever comes first. The event for this endpoint is relapse/progression or death.
Participants alive and disease free will be censored at last available disease assessment.
Measured: At 1 year
Overall Survival (OS)
Overall survival is defined as the time interval between date of transplant and death from any cause. The event for this endpoint is death from any cause. Surviving participants will be censored at last follow-up.
Measured: At 1 year and 2 years
Hematologic Recovery (Platelet Counts)
Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. The competing event is death or subsequent transplant without platelet recovery. For patients who never drop their platelet count below 20,000/mm3 or 50,000/mm3, the date of platelet recovery will be Day +1 post HCT.
Measured: Up to 2 years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start14 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannah Choe, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor-investigator, Hannah Choe, MD, Ohio State University Comprehensive Cancer Center
- Investigators
- Hannah Choe, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249346
- Sponsor's protocol ID
- OSU-24102
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-Randomized, Multi-Center Pilot Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for GVHD Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07249346
- Acronym / sponsor ID
- OSU-24102
- Conditions
- Leukemia, Myelodysplasia, Chronic Myelomonocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hannah Choe, MDUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Nov 2025 (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 an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).
Detailed description
Primary Objective:
To assess survival without severe Grade 3-4 acute GVHD at Day 180 post-transplant in patients treated with GVHD prophylaxis in myeloablative allogeneic hematopoietic stem cell transplantation for patients treated with low dose PTCy(Cyclophosphamide)/Tac(Tacrolimus)/Rux(Ruxolitinib).
Secondary Objectives:
To describe rates of Grade II-IV and Grades III-IV acute GVHD, chronic GVHD requiring immunosuppression, hematologic recovery (neutrophil and platelet), disease relapse or progression, rates of Grade 3+ toxicity, primary and secondary graft failure, and overall survival (OS) for patients treated with low dose PTCy/Tac/Rux.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Feasibility) | Experimental | Drug: Ruxolitinib, Drug: Myeloablative conditioning regimen, Procedure: Hematopoietic Stem Cell Transplantation, Drug: Cyclophosphamide, Drug: TacrolimusPatients will receive post-transplant cyclophosphamide 25 mg/kg on Days +3 and +4, tacrolimus, and ruxolitinib for GVHD prophylaxis. Ruxolitinib will be dosed as ruxolitinib IR 5 mg po qD (on fluconazole, 5 mg po BID not on fluconazole) starting Day -1 until Day +28 and neutrophil engraftment and then increase to ruxolitinib IR 5 mg po BID (on fluconazole,10 mg po BID not on fluconazole) for up to 12 months. Tacrolimus will be tapered after Day +90 per institutional guidelines. Patients will receive ruxolitinib up to Day 180 posttransplant. Ruxolitinib will be tapered over 2-3 months depending on the starting dose at time of taper. |
| Cohort 2 (dose expansion) | Experimental | Drug: Ruxolitinib, Drug: Myeloablative conditioning regimen, Procedure: Hematopoietic Stem Cell Transplantation, Drug: Cyclophosphamide, Drug: TacrolimusPatients will receive post-transplant cyclophosphamide 25 mg/kg on Days +3 and +4, tacrolimus, and ruxolitinib for GVHD prophylaxis. Ruxolitinib will be dosed as ruxolitinib IR 5 mg po qD (on fluconazole, 5 mg po BID not on fluconazole) starting Day -1 until Day +28 and neutrophil engraftment and then increase to ruxolitinib IR 5 mg po BID (on fluconazole,10 mg po BID not on fluconazole) for up to 12 months. Tacrolimus will be tapered after Day +90 per institutional guidelines. Patients will receive ruxolitinib up to Day 365 post-transplant. Ruxolitinib will be tapered over 2-3 months depending on the starting dose at time of taper. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age 18.0 years or older at the time of enrollment
- Patients undergoing allogeneic hematopoietic cell transplantation for one of the following indications:
- Patients must have a related or unrelated peripheral blood stem cell donor as follows:
- Unrelated donor must be willing to donate peripheral blood stem cells and meet National Marrow Donor Program (NMDP) criteria for donation.
- Donor selection must comply with 21 CFR 1271
Key exclusion criteria (21 listed)
- Prior allogeneic transplant
- Active CNS (central nervous system) involvement by malignant cells
- Patients with secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes, including CMML(chronic myelomonocytic leukemia) and MDS/MPN (myelodysplastic syndromes/myeloproliferative neoplasms) syndromes; patients with secondary acute myeloid leukemia arising from myelodysplastic neoplasm are eligible.
- Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
- Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., TB).
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 |
|---|---|---|
| RuxolitinibTaken PO | Drug | Cohort 1 (Feasibility), Cohort 2 (dose expansion) |
| Myeloablative conditioning regimenPatients will receive a full-intensity myeloablative conditioning regimen. Allowed regimens include: * Flu/Bu(130 mg/m2/day x 4 days) * Flu/TBI (8-12Gy) * Flu/Bu/Thiotepa The addition of alemtuzumab or ATG is not allowed. | Drug | Cohort 1 (Feasibility), Cohort 2 (dose expansion) |
| Hematopoietic Stem Cell TransplantationAlso: HCTPatients will undergo HCT | Procedure or surgery | Cohort 1 (Feasibility), Cohort 2 (dose expansion) |
| CyclophosphamideGiven IV | Drug | Cohort 1 (Feasibility), Cohort 2 (dose expansion) |
| TacrolimusGiven PO | Drug | Cohort 1 (Feasibility), Cohort 2 (dose expansion) |
Primary outcome
Severe acute GVHD-free Survival (SGFS)
Time frame: At day 180 post-transplant
SGFS will be calculated from the time of transplant to onset of grade 3-4 acute GVHD or death censoring patients alive without grade 3-4 GVHD at last clinical assessment date. The SGFS rate together with 95% confidence interval at day 180 will be estimated by Kaplan-Meier method.
11 secondary outcomes
GVHD, relapse free survival (GRFS)
Time frame: At 6 months and 1 year
Grade II-IV acute GVHD and Grade III-IV acute GVHD
Time frame: At 6 months
Chronic GVHD requiring immunosuppression
Time frame: At 1 year
GVHD Free Survival (GFS)
Time frame: At 1 year
Hematologic Recovery (Neutrophil Counts)
Time frame: Up to 2 years post transplant
Disease Relapse or Progression
Time frame: At 1 year
Non-relapse Mortality (NRM)
Time frame: At 1 year
Grade 3+ Toxicities
Time frame: Up to 2 years post transplant
Disease-Free Survival (DFS)
Time frame: At 1 year
Overall Survival (OS)
Time frame: At 1 year and 2 years
Hematologic Recovery (Platelet Counts)
Time frame: Up to 2 years post transplant
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 2 Sep 2026.
- The JameslineLink provided by the sponsor.
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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.
The Ohio State University Comprehensive Cancer Center contact
Hannah Choe, MD principal investigator
Ohio State University Comprehensive Cancer Center
3 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 Ruxolitinib, Myeloablative conditioning regimen and Hematopoietic Stem Cell Transplantation in people with Leukemia and Myelodysplasia, run by Hannah Choe, MD at 3 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 24 inclusion and 21 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 The Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe acute GVHD-free Survival (SGFS) (time frame: At day 180 post-transplant). 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 2 Sep 2026.