Essential ThrombocythemiaPhase 1/2NCT03878199
Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
A Phase 1/2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Liposome-encapsulated Daunorubicin-Cytarabine and Ruxolitinib in people with Essential Thrombocythemia and Myelofibrosis, run by Ohio State University Comprehensive Cancer Center at 3 sites in United States.
Trial summary
This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Thrombocythemia, Myelofibrosis, Myeloproliferative Neoplasm
- What is being tested?
- Allogeneic Hematopoietic Stem Cell Transplantation, Liposome-encapsulated Daunorubicin-Cytarabine and Ruxolitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Feb 2019to 27 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to understand and the willingness to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as:
- MPN-AP is defined by 10% to 19% blasts in the peripheral blood or bone marrow
- MPN-BP is defined by >= 20% blasts in the blood or bone marrow
- Either MPN-AP or MPN-BP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), primary or secondary myelofibrosis (MF), or MDS/MPN overlap with intermediate-2 or high risk disease according to IPSS as well as progression on or failure to respond to at least one line of therapy
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- Participants with ET, PV, or MF that have received prior MPN-associated therapy (e.g., hydroxyurea, hypomethylating agents [azacitidine, decitabine], anti-platelet therapies [e.g., aspirin, anagrelide], as well as JAK2 inhibitor therapy [e.g., ruxolitinib or other investigational JAK2 inhibitor]) are eligible. They must discontinue prior to starting therapy; no wash-out is required
- Female participants of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 30 days following the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Male participants of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days until the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment
- Left ventricular ejection fraction at >= 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan (14 days prior to initiating study treatment)
- Candidate for cytotoxic-intensive induction chemotherapy
- Willing to take oral medication
- Serum creatinine =< 2 x the upper limit of normal (ULN), or glomerular filtration rate > 20 ml/min/1.73m^2 as calculated by Cockcroft-Gault formula
- Serum potassium, magnesium, and calcium (corrected for albumin) within institutional normal limits or can be corrected with supplementation
- Total serum bilirubin =< 2.5 x ULN
- Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) =< 2.5 x ULN
Who cannot join
- Ongoing participation in another clinical trial
- Isolated myeloid sarcoma (i.e., participants must have blood or marrow involvement with AML to enter the study)
- Acute promyelocytic leukemia (French-American-British [FAB] M3 classification)
- Active central nervous system (CNS) involvement by AML
- Current treatment or treatment within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational drug protocol (unless there is evidence of rapidly progressive disease in which case a shorter interval from last therapy may be acceptable)
- Any unresolved toxicity equal to or greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity
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- Incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
- Participants with rapidly progressive disease (defined by blast count doubling within 48 hours) or organ dysfunction that would prevent them from receiving these agents
- Participants with uncontrolled infection will not be enrolled until infection is treated and symptoms controlled
- Participants with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for >= 72 hours (hrs)
- Known hypersensitivity to ruxolitinib, cytarabine, daunorubicin, or liposomal products
- History of Wilson's disease or other copper metabolism disorder
- Uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the protocol per investigator's discretion. Including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled ventricular arrhythmias
- Participants with prior cumulative anthracycline exposure of greater than 368 mg/m^2 daunorubicin (or equivalent)
- All participants must discontinue anti-platelet agents or anticoagulants prior to initiation of study drug, including therapeutic doses of aspirin and clopidogrel
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Simmons Cancer Center
Dallas, Texas, 75390
OHSU
Portland, Oregon, 97239
About this study
Official title: A Phase I/II, Open-Label, Multi-Center Study Evaluating the Safety and Efficacy of Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.
Read the detailed description
PRIMARY OBJECTIVES:
- To identify the maximum-tolerated dose (MTD) of ruxolitinib in combination with liposome-encapsulated daunorubicin-cytarabine (CPX-351). (Phase I) II. To evaluate the objective response rate in participants with post-myeloproliferative neoplasm (MPN)- accelerated phase (AP)/blast phase (BP) following treatment with the combination of ruxolitinib and CPX-351 (per 2012 MPN-BP criteria). (Phase II)
SECONDARY OBJECTIVES:
- To evaluate the safety and tolerability of ruxolitinib in combination with CPX-351. (Phase I) II. Assess survival outcomes and proportion of patients receiving transplant associated with ruxolitinib in combination with CPX-351. (Phase II)
EXPLORATORY OBJECTIVES:
- To evaluate the rate of response among participants with MPN-AP/BP using European Leukemia Net (ELN) criteria.
II. Assess the proportion of treated participants with minimal residual disease. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of ruxolitinib followed by a phase II study.
INDUCTION: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5 and ruxolitinib orally (PO) twice daily (BID) on days 6-28 of cycle 1.
RE-INDUCTION: Patients with significant residual disease may receive CPX-351 IV on days 1 and 3 and ruxolitinib PO BID on days 4-28 of cycle 2 per the discretion of the treating physician. Patients who have persistent disease following 2 cycles of therapy (induction and re-induction) will be offered salvage chemotherapy.
CONSOLIDATION: Patients that have =< 5% blasts in bone marrow receive CPX-351 IV on days 1 and 3 and ruxolitinib PO BID on days 4-28. Treatment repeats every 28 days for up to 2 cycles provided that counts have partially recovered in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients who successfully complete consolidation therapy with a continued =< 5% blasts in bone marrow and have not undergone an allogeneic stem cell transplantation (SCT) receive ruxolitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
ALLOGENEIC STEM CELL TRANSPLANTATION: Patients may undergo an allogeneic SCT at any time after achieving =< 5% blasts in bone marrow if they have a suitable donor.
After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 1 year.
- Conditions
- Essential Thrombocythemia, Myelofibrosis, Myeloproliferative Neoplasm, Polycythemia Vera, Secondary Acute Myeloid Leukemia
- Being tested
- Allogeneic Hematopoietic Stem Cell Transplantation, Liposome-encapsulated Daunorubicin-Cytarabine, Ruxolitinib
- Medical subject headings
- Thrombocythemia, Essential, Primary Myelofibrosis, Myeloproliferative Disorders, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC
Undergo allogeneic SCT
Liposome-encapsulated Daunorubicin-CytarabineDrug
Also called CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Daunorubicin and Cytarabine (Liposomal), Liposomal AraC-Daunorubicin CPX-351
Given IV
RuxolitinibDrug
Also called INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CPX-351, ruxolitinib, allogeneic SCT) | Experimental | See Detailed Description. Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) (Phase I)
DLT occurrence after exposure to ruxolitinib and CPX-351.
Measured: Day 1 to day 42
Proportion of Participants That Achieve at Least an Acute Leukemia Response-Partial Response (>= ALR-P, Per 2012 Myeloproliferative Neoplasm - Blast Phase [MPN-BP] Criteria) (Phase 2)
Will compute the proportion of efficacy-evaluable participants achieving objective response rate (ORR) and the exact binominal 95% confidence interval. The ORR will be calculated as the proportion of participants that achieve at least an Acute Leukemia Response-Partial response (≥ ALR-P, per 2012 MPN-BP criteria).
Measured: Day 1 to end of induction or re-induction cycle (or upon assessment of the bone marrow biopsy performed near the end of these cycles if this occurs later). Cycle length is 28 days.
Secondary outcomes (6)
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
The number of participants with treatment-related toxicity and the exact confidence interval will be measured. Each toxicity event will be tabulated and summarized by severity and major organ site according to the CTCAE version (v)5.0.
Measured: Up to 30 days after last on-study dose, up to 9 months.
Overall Survival (OS)
Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate overall survival.
Measured: Up to 4 years.
Event-free Survival (EFS)
Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate event-free survival.
Measured: Day 1 to treatment failure, progressive disease, relapse, last exam date, or death (whichever is first), up to 2 years
Relapse-free Survival (RFS)
Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate relapse-free survival.
Measured: Date of first documented response (ALR-C) to date of relapse or death from any cause, up to 2 years.
Remission Duration
Time-to-event analysis (e.g., Kaplan-Meier curves or cumulative incidence curves) will be used to evaluate remission duration.
Measured: Date of first documented response (ALR-C) to date of documented relapse, up to 2 years
Proportion of Participants Proceeding to Transplant
A point estimate and 95% confidence interval will be computed for the proportion of participants who undergo an allogeneic (allo)-SCT (stem cell transplant).
Measured: Date of enrollment to time of transplant or end of follow-up (if no transplant), up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 Feb 2019
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Why it stopped: The study was originally planned to assess four escalating DLs of ruxolitinib (upto 40 mg twice daily), but was closed early due to slow enrollment and changing treatment landscape moving towards less intense approaches.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential ThrombocythemiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, Jazz Pharmaceuticals
- Responsible party
- Principal investigator, Uma Borate, Ohio State University Comprehensive Cancer Center
- Investigators
- Uma Borate, MD, Principal investigator, The Ohio State Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878199
- Sponsor's protocol ID
- OSU-20393
- Other IDs
- NCI-2019-03712
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2019
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multi-Center Study Evaluating the Safety and Efficacy of Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT03878199
- Acronym / sponsor ID
- OSU-20393
- Conditions
- Essential Thrombocythemia, Myelofibrosis, Myeloproliferative Neoplasm, Polycythemia Vera, Secondary Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was originally planned to assess four escalating DLs of ruxolitinib (upto 40 mg twice daily), but was closed early due to slow enrollment and changing treatment landscape moving towards less intense approaches.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation, Jazz Pharmaceuticals
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the best dose of ruxolitinib when given together with CPX-351 and to see how well they work in treating patients with accelerated phase or blast phase myeloproliferative neoplasm. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. CPX-351 is a mixture of 2 chemotherapy drugs (daunorubicin and cytarabine) given for leukemia in small fat-based particles (liposomes) to improve the drug getting into cancer cells. Giving ruxolitinib and CPX-351 may work better in treating patients with secondary acute myeloid leukemia compared to CPX-351 alone.
Detailed description
PRIMARY OBJECTIVES:
- To identify the maximum-tolerated dose (MTD) of ruxolitinib in combination with liposome-encapsulated daunorubicin-cytarabine (CPX-351). (Phase I) II. To evaluate the objective response rate in participants with post-myeloproliferative neoplasm (MPN)- accelerated phase (AP)/blast phase (BP) following treatment with the combination of ruxolitinib and CPX-351 (per 2012 MPN-BP criteria). (Phase II)
SECONDARY OBJECTIVES:
- To evaluate the safety and tolerability of ruxolitinib in combination with CPX-351. (Phase I) II. Assess survival outcomes and proportion of patients receiving transplant associated with ruxolitinib in combination with CPX-351. (Phase II)
EXPLORATORY OBJECTIVES:
- To evaluate the rate of response among participants with MPN-AP/BP using European Leukemia Net (ELN) criteria.
II. Assess the proportion of treated participants with minimal residual disease. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of ruxolitinib followed by a phase II study.
INDUCTION: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5 and ruxolitinib orally (PO) twice daily (BID) on days 6-28 of cycle 1.
RE-INDUCTION: Patients with significant residual disease may receive CPX-351 IV on days 1 and 3 and ruxolitinib PO BID on days 4-28 of cycle 2 per the discretion of the treating physician. Patients who have persistent disease following 2 cycles of therapy (induction and re-induction) will be offered salvage chemotherapy.
CONSOLIDATION: Patients that have =< 5% blasts in bone marrow receive CPX-351 IV on days 1 and 3 and ruxolitinib PO BID on days 4-28. Treatment repeats every 28 days for up to 2 cycles provided that counts have partially recovered in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients who successfully complete consolidation therapy with a continued =< 5% blasts in bone marrow and have not undergone an allogeneic stem cell transplantation (SCT) receive ruxolitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
ALLOGENEIC STEM CELL TRANSPLANTATION: Patients may undergo an allogeneic SCT at any time after achieving =< 5% blasts in bone marrow if they have a suitable donor.
After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CPX-351, ruxolitinib, allogeneic SCT) | Experimental | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Drug: Liposome-encapsulated Daunorubicin-Cytarabine, Drug: RuxolitinibSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as:
- Female participants of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 30 days following the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Male participants of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days until the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment
Key exclusion criteria (16 listed)
- Ongoing participation in another clinical trial
- Isolated myeloid sarcoma (i.e., participants must have blood or marrow involvement with AML to enter the study)
- Acute promyelocytic leukemia (French-American-British [FAB] M3 classification)
- Active central nervous system (CNS) involvement by AML
- Current treatment or treatment within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational drug protocol (unless there is evidence of rapidly progressive disease in which case a shorter interval from last therapy may be acceptable)
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 |
|---|---|---|
| Allogeneic Hematopoietic Stem Cell TransplantationAlso: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSCUndergo allogeneic SCT | Procedure or surgery | Treatment (CPX-351, ruxolitinib, allogeneic SCT) |
| Liposome-encapsulated Daunorubicin-CytarabineAlso: CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Daunorubicin and Cytarabine (Liposomal), Liposomal AraC-Daunorubicin CPX-351Given IV | Drug | Treatment (CPX-351, ruxolitinib, allogeneic SCT) |
| RuxolitinibAlso: INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424Given PO | Drug | Treatment (CPX-351, ruxolitinib, allogeneic SCT) |
Primary outcome
Dose Limiting Toxicity (DLT) (Phase I)
Time frame: Day 1 to day 42
DLT occurrence after exposure to ruxolitinib and CPX-351.
Proportion of Participants That Achieve at Least an Acute Leukemia Response-Partial Response (>= ALR-P, Per 2012 Myeloproliferative Neoplasm - Blast Phase [MPN-BP] Criteria) (Phase 2)
Time frame: Day 1 to end of induction or re-induction cycle (or upon assessment of the bone marrow biopsy performed near the end of these cycles if this occurs later). Cycle length is 28 days.
Will compute the proportion of efficacy-evaluable participants achieving objective response rate (ORR) and the exact binominal 95% confidence interval. The ORR will be calculated as the proportion of participants that achieve at least an Acute Leukemia Response-Partial response (≥ ALR-P, per 2012 MPN-BP criteria).
6 secondary outcomes
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: Up to 30 days after last on-study dose, up to 9 months.
Overall Survival (OS)
Time frame: Up to 4 years.
Event-free Survival (EFS)
Time frame: Day 1 to treatment failure, progressive disease, relapse, last exam date, or death (whichever is first), up to 2 years
Relapse-free Survival (RFS)
Time frame: Date of first documented response (ALR-C) to date of relapse or death from any cause, up to 2 years.
Remission Duration
Time frame: Date of first documented response (ALR-C) to date of documented relapse, up to 2 years
Proportion of Participants Proceeding to Transplant
Time frame: Date of enrollment to time of transplant or end of follow-up (if no transplant), up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Uma Borate, MD principal investigator
The Ohio State 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 1/2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Liposome-encapsulated Daunorubicin-Cytarabine and Ruxolitinib in people with Essential Thrombocythemia and Myelofibrosis, run by Ohio State University Comprehensive Cancer Center 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 16 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Limiting Toxicity (DLT) (Phase I) (time frame: Day 1 to day 42). 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 24 Apr 2026.