Clinical trial · Interventional
The Role of Ruxolitinib in Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Neoplasm
Concomitant Ruxolitinib Induction and Maintenance With Cytarabine Based Chemotherapy in Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Neoplasm
NCT03558607CI-TRIAL-00044151unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial aimed to investigate the therapeutic efficacy of ruxolitinib in combination with cytotoxic chemotherapy for post-myeloproliferative neoplasm secondary acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- interventionNames
- Drug: Ruxolitinib
Primary outcomes (2)
- measure
- complete remission rate
- timeFrame
- After 12 months from induction chemotherapy
- measure
- complete remission with incompletre recovery rate
- timeFrame
- After 12 months from induction chemotherapy
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- 3, 6, 12, 24 months after induction chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically confirmed AML following MPN * ECOG performance status 2 or better * Adequate physical condition that could tolerate cytotoxic induction chemotherapy judged by investigator * Age 18 years or older * Adequate cardiac function * Adequate hepatic, and renal function * Serum creatinine ≤ 2.5 mg/dl * ALT (SGOT) and/or AST (SGPT) equal to or than 1.5 x upper limit of normal * Life expectancy of ≥ 3 months * Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment * For women of childbearing age, it should be confirmed that they are not pregnant and that they should be contraception during the study period and for up to 4 weeks after the end of the study * Male should agree to the barrier method during the study period and up to four weeks after the end of the study Exclusion Criteria: * Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri * Pregnancy or breast feeding * Other severe acute or chronic medical or psychiatric condition * Prior treatment with ruxolitinib * Patients who received other chemotherapy within 2 weeks of the study enrollment * Patients participating in other clinical studies at the time of registration
References
Publications (11)
- BACKGROUNDAbdulkarim K, Girodon F, Johansson P, Maynadie M, Kutti J, Carli PM, Bovet E, Andreasson B. AML transformation in 56 patients with Ph- MPD in two well defined populations. Eur J Haematol. 2009 Feb;82(2):106-11. doi: 10.1111/j.1600-0609.2008.01163.x. PMID 19134023
- BACKGROUNDKoh Y, Kim I, Bae JY, Song EY, Kim HK, Yoon SS, Lee DS, Park SS, Park MH, Park S, Kim BK. Prognosis of secondary acute myeloid leukemia is affected by the type of the preceding hematologic disorders and the presence of trisomy 8. Jpn J Clin Oncol. 2010 Nov;40(11):1037-45. doi: 10.1093/jjco/hyq097. Epub 2010 Jun 29. PMID 20587614
- BACKGROUNDMesa RA, Li CY, Ketterling RP, Schroeder GS, Knudson RA, Tefferi A. Leukemic transformation in myelofibrosis with myeloid metaplasia: a single-institution experience with 91 cases. Blood. 2005 Feb 1;105(3):973-7. doi: 10.1182/blood-2004-07-2864. Epub 2004 Sep 23. PMID 15388582
- BACKGROUNDPassamonti F, Rumi E, Arcaini L, Castagnola C, Lunghi M, Bernasconi P, Giovanni Della Porta M, Columbo N, Pascutto C, Cazzola M, Lazzarino M. Leukemic transformation of polycythemia vera: a single center study of 23 patients. Cancer. 2005 Sep 1;104(5):1032-6. doi: 10.1002/cncr.21297. PMID 16047334
- BACKGROUNDTam CS, Nussenzveig RM, Popat U, Bueso-Ramos CE, Thomas DA, Cortes JA, Champlin RE, Ciurea SE, Manshouri T, Pierce SM, Kantarjian HM, Verstovsek S. The natural history and treatment outcome of blast phase BCR-ABL- myeloproliferative neoplasms. Blood. 2008 Sep 1;112(5):1628-37. doi: 10.1182/blood-2008-02-138230. Epub 2008 Jun 19. PMID 18566326
- BACKGROUNDCherington C, Slack JL, Leis J, Adams RH, Reeder CB, Mikhael JR, Camoriano J, Noel P, Fauble V, Betcher J, Higgins MS, Gillette-Kent G, Tremblay LD, Peterson ME, Olsen JJ, Tibes R, Mesa RA. Allogeneic stem cell transplantation for myeloproliferative neoplasm in blast phase. Leuk Res. 2012 Sep;36(9):1147-51. doi: 10.1016/j.leukres.2012.04.021. Epub 2012 May 11.