Myelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePhase 2NCT01787487
Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm
A Phase 2 study testing Azacitidine, Laboratory Biomarker Analysis and Ruxolitinib Phosphate in people with Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable and Myelofibrosis Transformation in Essential Thrombocythemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate 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
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelofibrosis Transformation in Essential Thrombocythemia, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
- What is being tested?
- Azacitidine, Laboratory Biomarker Analysis and Ruxolitinib Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2013to 20 Jan 2026
- Phase
- Phase 2
- 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 with a diagnosis of primary myelofibrosis (PM), post polycythemia vera myelofibrosis (PPV MF), or post essential thrombocythemia myelofibrosis (PET MF) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to International Working Group (IWG-MRT) criteria
- Patients with a diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm, unclassifiable (MDS/MPN-U) that require therapy
- Understanding and voluntarily signing an Institutional Review Board (IRB)-approved informed consent form
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Direct bilirubin of =< 2 mg/dL
- Serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN) or 5 x ULN if related to MF or MDS/MPN associated liver infiltration
Show all 10Show fewer
- If total bilirubin is =< 2, fractionation is not required for eligibility determination
- Creatinine =< 2.5 mg/dL
- Platelets >= 50 x 10^9/L
- Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Who cannot join
- For the MF and MDS/MPN-U arms (arms 1 \& 2), use of any other standard drug (except hydroxyurea, anagrelide, growth factors, Revlimid, clofarabine, etc) or experimental drug or therapy within 14 days of starting study therapy
- Patients previously treated with RUX or AZA (only applicable for the MF and MDS/MPN arms)
- Any serious psychological condition or psychiatric illness that would prevent the subject from signing the informed consent document, in the investigator opinion
- Pregnant or lactating females
- Subjects of childbearing potential who are unwilling to take appropriate precautions (from screening through follow-up) to avoid becoming pregnant or fathering a child; females of non-childbearing potential are defined as women who a) are 55 years of age with history of amenorrhea for 1 year OR b) are surgically sterile for at least 3 months; for females of childbearing potential, or for males, pregnancy must be avoided by taking appropriate precautions; these precautions and the methods of contraception should be communicated to the subjects and their understanding confirmed
- Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Known positive for human immunodeficiency virus (HIV) or with known active infectious hepatitis, type A, B or C
- Patients with active malignancy of other type than required for this study, are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ruxolitinib and Azacytidine Combination as a Therapy for Patients With Myelofibrosis and Myelodysplastic Syndrome/ Myeloproliferative Neoplasm
This phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacytidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate and azacytidine may be an effective treatment for myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of the combination of RUX (ruxolitinib phosphate) with AZA (azacytidine) in patients with myelofibrosis (MF) (primary myelofibrosis, post polycythemia vera myelofibrosis, or post essential thrombocythemia myelofibrosis [PMF, post- PV MF, or post - ET MF]) in achieving objective improvements in disease status.
II. To determine the efficacy of the combination of RUX + AZA in patients with myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (breakpoint cluster region [BCR]-c-abl oncogene 1, non-receptor tyrosine kinase [ABL1] negative: aCML), and myelodysplastic syndromes/myeloproliferative neoplasms, unclassifiable (MDS/MPN-U), in achieving objective improvements in disease status.
SECONDARY OBJECTIVES:
- To determine the safety of the RUX + AZA combination in patients with MF and MDS/MPN.
TERTIARY OBJECTIVES:
- To explore time to response (TTR) and duration of response (DOR). II. To explore the effect of the combination on anemia and transfusion dependence in patients with MF and MDS/MPN.
III. To explore the impact of baseline mutational profile on International Working Group (IWG)-Myeloproliferative Neoplasms Research and Treatment (MRT) response and overall survival in patients with MF and MDS/MPN.
IV. To explore the impact of baseline anemia on overall survival in patients with MF and MDS/MPN.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I (MF): Patients with MF receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Beginning course 4, patients also receive azacytidine subcutaneously (SC) or intravenously (IV) for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity.
ARM II (MDS/MPN): Patients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I.
After completion of study treatment, patients are followed up for 30 days and up to 5 years.
- Conditions
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelofibrosis Transformation in Essential Thrombocythemia, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Primary Myelofibrosis
- Being tested
- Azacitidine, Laboratory Biomarker Analysis, Ruxolitinib Phosphate
- Medical subject headings
- Myeloproliferative Disorders, Polycythemia Vera, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC
Given SC or IV
Laboratory Biomarker AnalysisOther
Correlative studies
Ruxolitinib PhosphateDrug
Also called INCB-18424 Phosphate, Jakafi
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MF patients) | Experimental | Patients with MF receive ruxolitinib phosphate PO BID on days 1-28. Beginning course 4, patients also receive azacytidine SC or IV for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Azacitidine; Other: Laboratory Biomarker Analysis; Drug: Ruxolitinib Phosphate |
| Arm II (MDS/MPN patients) | Experimental | Patients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I. Receives: Drug: Azacitidine; Other: Laboratory Biomarker Analysis; Drug: Ruxolitinib Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (complete remission, partial remission, clinical improvement) in patients with myelofibrosis
The method of Thall, Simon and Estey will be used for futility monitoring for this study. The objective response rate will be estimated along with the Bayesian 95% credible interval.
Measured: Up to 24 weeks
Objective response rate (complete remission, partial remission, and hematologic improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
The method of Thall, Simon and Estey will be used for futility monitoring for this study.
Measured: Up to 24 weeks
Secondary outcomes (1)
Incidence of adverse events defined as grade 3-4 clinically relevant non-hematologic toxicity or a serious adverse event that is felt to be drug related as assessed by the Common Terminology Criteria for Adverse Events version 4.0
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study.
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study start13 Mar 2013
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic/Myeloproliferative Neoplasm, UnclassifiableStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Naval Daver, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787487
- Sponsor's protocol ID
- 2012-0737
- Other IDs
- NCI-2013-00704, 2012-0737
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2013
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Arora S, Senapati J, Deshmukh I, Bose P, Masarova L, Loghavi S, Wang X, Nogueras-Gonzalez G, Montalban-Bravo G, Borthakur G, DiNardo CD, Kadia T, Zhou L, Saenz D, Halim H, Alvarado Y, Ohanian M, Takahashi K, Short NJ, Jabbour E, Ravandi F, Garcia-Manero G, Pemmaraju N, Daver NG. Final analysis of phase 2 clinical trial of ruxolitinib and azacitidine combination therapy in patients with myelodysplastic syndrome/myeloproliferative neoplasms. J Hematol Oncol. 2026 Jun 16. doi: 10.1186/s13045-026-01813-7. Online ahead of print.
PubMed 42304430Masarova L, Verstovsek S, Hidalgo-Lopez JE, Pemmaraju N, Bose P, Estrov Z, Jabbour EJ, Ravandi-Kashani F, Takahashi K, Cortes JE, Ning J, Ohanian M, Alvarado Y, Zhou L, Pierce S, Gergis R, Patel KP, Luthra R, Kadia TM, DiNardo CD, Borthakur G, Bhalla K, Garcia-Manero G, Bueso-Ramos CE, Kantarjian HM, Daver N. A phase 2 study of ruxolitinib in combination with azacitidine in patients with myelofibrosis. Blood. 2018 Oct 18;132(16):1664-1674. doi: 10.1182/blood-2018-04-846626. Epub 2018 Sep 5.
PubMed 30185431Assi R, Kantarjian HM, Garcia-Manero G, Cortes JE, Pemmaraju N, Wang X, Nogueras-Gonzalez G, Jabbour E, Bose P, Kadia T, Dinardo CD, Patel K, Bueso-Ramos C, Zhou L, Pierce S, Gergis R, Tuttle C, Borthakur G, Estrov Z, Luthra R, Hidalgo-Lopez J, Verstovsek S, Daver N. A phase II trial of ruxolitinib in combination with azacytidine in myelodysplastic syndrome/myeloproliferative neoplasms. Am J Hematol. 2018 Feb;93(2):277-285. doi: 10.1002/ajh.24972. Epub 2017 Nov 27.
PubMed 29134664
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ruxolitinib and Azacytidine Combination as a Therapy for Patients With Myelofibrosis and Myelodysplastic Syndrome/ Myeloproliferative Neoplasm
- ClinicalTrials.gov ID
- NCT01787487
- Acronym / sponsor ID
- 2012-0737
- Conditions
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Myelofibrosis Transformation in Essential Thrombocythemia, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Primary Myelofibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 8 Feb 2013 (estimated)
- 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 phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacytidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate and azacytidine may be an effective treatment for myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm.
Detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of the combination of RUX (ruxolitinib phosphate) with AZA (azacytidine) in patients with myelofibrosis (MF) (primary myelofibrosis, post polycythemia vera myelofibrosis, or post essential thrombocythemia myelofibrosis [PMF, post- PV MF, or post - ET MF]) in achieving objective improvements in disease status.
II. To determine the efficacy of the combination of RUX + AZA in patients with myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (breakpoint cluster region [BCR]-c-abl oncogene 1, non-receptor tyrosine kinase [ABL1] negative: aCML), and myelodysplastic syndromes/myeloproliferative neoplasms, unclassifiable (MDS/MPN-U), in achieving objective improvements in disease status.
SECONDARY OBJECTIVES:
- To determine the safety of the RUX + AZA combination in patients with MF and MDS/MPN.
TERTIARY OBJECTIVES:
- To explore time to response (TTR) and duration of response (DOR). II. To explore the effect of the combination on anemia and transfusion dependence in patients with MF and MDS/MPN.
III. To explore the impact of baseline mutational profile on International Working Group (IWG)-Myeloproliferative Neoplasms Research and Treatment (MRT) response and overall survival in patients with MF and MDS/MPN.
IV. To explore the impact of baseline anemia on overall survival in patients with MF and MDS/MPN.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I (MF): Patients with MF receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Beginning course 4, patients also receive azacytidine subcutaneously (SC) or intravenously (IV) for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity.
ARM II (MDS/MPN): Patients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I.
After completion of study treatment, patients are followed up for 30 days and up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (MF patients) | Experimental | Drug: Azacitidine, Other: Laboratory Biomarker Analysis, Drug: Ruxolitinib PhosphatePatients with MF receive ruxolitinib phosphate PO BID on days 1-28. Beginning course 4, patients also receive azacytidine SC or IV for 5 days. Treatment repeats every 28 days for 15 courses in the absence of disease progression or unacceptable toxicity. |
| Arm II (MDS/MPN patients) | Experimental | Drug: Azacitidine, Other: Laboratory Biomarker Analysis, Drug: Ruxolitinib PhosphatePatients with MDS/MPN receive ruxolitinib phosphate and azacytidine as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a diagnosis of primary myelofibrosis (PM), post polycythemia vera myelofibrosis (PPV MF), or post essential thrombocythemia myelofibrosis (PET MF) requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to International Working Group (IWG-MRT) criteria
- Patients with a diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm, unclassifiable (MDS/MPN-U) that require therapy
- Understanding and voluntarily signing an Institutional Review Board (IRB)-approved informed consent form
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Direct bilirubin of =< 2 mg/dL
Key exclusion criteria (8 listed)
- For the MF and MDS/MPN-U arms (arms 1 \& 2), use of any other standard drug (except hydroxyurea, anagrelide, growth factors, Revlimid, clofarabine, etc) or experimental drug or therapy within 14 days of starting study therapy
- Patients previously treated with RUX or AZA (only applicable for the MF and MDS/MPN arms)
- Any serious psychological condition or psychiatric illness that would prevent the subject from signing the informed consent document, in the investigator opinion
- Pregnant or lactating females
- Subjects of childbearing potential who are unwilling to take appropriate precautions (from screening through follow-up) to avoid becoming pregnant or fathering a child; females of non-childbearing potential are defined as women who a) are 55 years of age with history of amenorrhea for 1 year OR b) are surgically sterile for at least 3 months; for females of childbearing potential, or for males, pregnancy must be avoided by taking appropriate precautions; these precautions and the methods of contraception should be communicated to the subjects and their understanding confirmed
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 |
|---|---|---|
| AzacitidineAlso: 5 AZC, 5-AC, 5-Azacytidine, 5-AZCGiven SC or IV | Drug | Arm I (MF patients), Arm II (MDS/MPN patients) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (MF patients), Arm II (MDS/MPN patients) |
| Ruxolitinib PhosphateAlso: INCB-18424 Phosphate, JakafiGiven PO | Drug | Arm I (MF patients), Arm II (MDS/MPN patients) |
Primary outcome
Objective response rate (complete remission, partial remission, clinical improvement) in patients with myelofibrosis
Time frame: Up to 24 weeks
The method of Thall, Simon and Estey will be used for futility monitoring for this study. The objective response rate will be estimated along with the Bayesian 95% credible interval.
Objective response rate (complete remission, partial remission, and hematologic improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
Time frame: Up to 24 weeks
The method of Thall, Simon and Estey will be used for futility monitoring for this study.
1 secondary outcome
Incidence of adverse events defined as grade 3-4 clinically relevant non-hematologic toxicity or a serious adverse event that is felt to be drug related as assessed by the Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days after completion of study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 42304430Arora S, Senapati J, Deshmukh I, Bose P, Masarova L, Loghavi S, Wang X, Nogueras-Gonzalez G, Montalban-Bravo G, Borthakur G, DiNardo CD, Kadia T, Zhou L, Saenz D, Halim H, Alvarado Y, Ohanian M, Takahashi K, Short NJ, Jabbour E, Ravandi F, Garcia-Manero G, Pemmaraju N, Daver NG. Final analysis of phase 2 clinical trial of ruxolitinib and azacitidine combination therapy in patients with myelodysplastic syndrome/myeloproliferative neoplasms. J Hematol Oncol. 2026 Jun 16. doi: 10.1186/s13045-026-01813-7. Online ahead of print.
- Derived from this study: PubMed 30185431Masarova L, Verstovsek S, Hidalgo-Lopez JE, Pemmaraju N, Bose P, Estrov Z, Jabbour EJ, Ravandi-Kashani F, Takahashi K, Cortes JE, Ning J, Ohanian M, Alvarado Y, Zhou L, Pierce S, Gergis R, Patel KP, Luthra R, Kadia TM, DiNardo CD, Borthakur G, Bhalla K, Garcia-Manero G, Bueso-Ramos CE, Kantarjian HM, Daver N. A phase 2 study of ruxolitinib in combination with azacitidine in patients with myelofibrosis. Blood. 2018 Oct 18;132(16):1664-1674. doi: 10.1182/blood-2018-04-846626. Epub 2018 Sep 5.
- Derived from this study: PubMed 29134664Assi R, Kantarjian HM, Garcia-Manero G, Cortes JE, Pemmaraju N, Wang X, Nogueras-Gonzalez G, Jabbour E, Bose P, Kadia T, Dinardo CD, Patel K, Bueso-Ramos C, Zhou L, Pierce S, Gergis R, Tuttle C, Borthakur G, Estrov Z, Luthra R, Hidalgo-Lopez J, Verstovsek S, Daver N. A phase II trial of ruxolitinib in combination with azacytidine in myelodysplastic syndrome/myeloproliferative neoplasms. Am J Hematol. 2018 Feb;93(2):277-285. doi: 10.1002/ajh.24972. Epub 2017 Nov 27.
- MD Anderson Cancer CenterLink 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. This study is not recruiting at the moment.
Naval Daver, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Laboratory Biomarker Analysis and Ruxolitinib Phosphate in people with Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable and Myelofibrosis Transformation in Essential Thrombocythemia, run by M.D. Anderson Cancer Center at 1 site 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (complete remission, partial remission, clinical improvement) in patients with myelofibrosis (time frame: Up to 24 weeks). 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?
On the ClinicalTrials.gov record for NCT01787487, which also lists 3 linked publications.
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 31 Mar 2026.