Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
Relapsed or refractory chronic myelomonocytic leukemia (CMML), and other MDS/myeloproliferative neoplasm (MPN) overlap syndromes, with no available therapies
Chronic Myelomonocytic Leukemia (CMML) with < 10% blasts in the bone marrow
For expansion, subjects may have a pathologically confirmed diagnosis of MF or PV as noted above; there are two expansion cohorts for patients with myelodysplasia/myeloproliferative neoplasm (MDS/MPN) (chronic myelomonocytic leukemia [CMML], atypical chronic myelogenous leukemia [aCML], refractory anemia with ringed sideroblasts and thrombocytosis [RARS-T] or MDS/MPN-unclassifiable [U]) which warrants treatment; patients with these diagnoses may be eligible, provided they are able to obtain ruxolitinib from commercial supply
Chronic myelomonocytic leukemia (CMML) should be classified as:\r\n* CMML-1 or CMML-2 based on World Health Organization (WHO) classification of 2008
Myeloproliferative/myelodysplastic syndrome other than CMML. CMML with t(5;12) that have not yet received imatinib.
Leukemia other than CMML
Patient must have a documented diagnosis of myelodysplastic syndrome (MDS) of at least three months duration (MDS duration >= 3 months) according to World Health Organization (WHO) criteria or non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cells [WBC] =< 12,000/L)
Previously untreated MDS with isolated del5q (for which lenalidomide is approved an approved therapy) and chronic myelomonocytic leukemia (CMML) with rearrangements of the PDGF receptor (for which imatinib is approved therapy), unless they have previously failed these approaches
Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) (i.e., with white blood cell [WBC] <13,000/?L) or low-blast acute myelogenous leukemia (AML).
Myelodysplasia (MDS)/myeloproliferative syndrome (MPS)/chronic myelomonocytic leukemia (CMML) – patients must have < 5% marrow blasts at time of transplant
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML) who have not received induction chemotherapy
Chronic myelomonocytic leukemia (CMML)
Chronic myelomonocytic leukemia (CMML)
Patients must not have a secondary acute myeloid leukemia (AML) (defined as a history of prior radiation therapy or systemic chemotherapy, antecedent myelodysplastic syndrome [MDS], myeloproliferative neoplasm [MPN] or chronic myelomonocytic leukemia [CMML])
A diagnosis of chronic myelomonocytic leukemia (CMML), unless in morphologic CR
Myeloproliferative neoplasms (MPN) and myelodysplastic/myeloproliferative overlap neoplasms\r\n* Myelofibrosis with adverse-risk features\r\n* Polycythemia vera\r\n* Essential thrombocythemia\r\n* Chronic myelomonocytic leukemia
Chronic myelomonocytic leukemia (CMML): CMML-1 and CMML-2
MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
Chronic myelomonocytic leukemia
Juvenile myelomonocytic leukemia
Chronic myelomonocytic leukemia: CMML-1 and CMML-2
Juvenile myelomonocytic leukemia
Chronic myelomonocytic leukemia (CMML)
Juvenile myelomonocytic leukemia (JMML)
MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia [CMML], and MDS/myeloproliferative neoplasm [MPN] unclassifiable syndromes)
Patients with chronic myelomonocytic leukemia (CMML) are allowed to be enrolled
Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
Patient must have documented diagnosis of MDS lasting at least three months (MDS duration >= 3 months) according to World Health Organization (WHO) criteria or non-proliferative chronic myelomonocytic leukemia (CMML) (white blood cell [WBC] < 12,000/mcL)
Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic leukemia (CMML); WBC must be < 12,000/mcL
Chronic myelomonocytic leukemia
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
Juvenile myelomonocytic leukemia (JMML)
Chronic myelomonocytic leukemia (CMML)-1 and CMML-2, advanced polycythemia vera, and myelofibrosis\r\n* Patients must have a healthy human leukocyte antigen (HLA) compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo bone marrow (BM) harvesting or peripheral blood stem cell (PBSC) apheresis after filgrastim (G-CSF) administration; BM will be the preferred graft source\r\n* Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
Proliferative type chronic myelomonocytic leukemia with white blood cell count >12 Gi/L at any time during the 28 days before Day 1
Intermediate-2 or High-grade risk MDS (including chronic myelomonocytic leukemia (CMML))
High-risk myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) including chronic myelomonocytic leukemia 2 (CMML2) as defined by 10-19% myeloid blasts in either blood or marrow
Chronic myelomonocytic leukemia
Juvenile myelomonocytic leukemia
Patients with myelofibrosis (Lille > 0, transfusion dependency, progression to blast phase; however, in remission from AML) or chronic myelomonocytic leukemia (CMML); these patients will be treated with the reduced-intensity conditioning regimen #2 and will be subject to the same stopping rule as the group >= 55 years or with comorbidities
Confirmed diagnosis of:\r\n* Primary myelofibrosis (MF) or post-polycythemia vera (PV)/essential thrombocythemia (ET) MF classified as high risk, intermediate-2 risk, or intermediate-1 risk who are unresponsive or unable to receive current therapy which may or may not include ruxolitinib; OR\r\n* MPN/MDS syndrome (chronic myelomonocytic leukemia [CMML], juvenile myelomonocytic leukemia [JMML], atypical chronic myeloid leukemia [aCML], or MDS/MPN unclassifiable)
Expected chronic thrombocytopenia in patients with newly diagnosed marrow failure syndromes, myelodysplastic syndromes, aplastic anemia, chronic myelomonocytic leukemia or myelofibrosis or;
Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Chronic myeloid leukemia, primary myelofibrosis, chronic myelomonocytic leukemia
Active myeloproliferative neoplasms (MPN) and chronic myelomonocytic leukemia (CMML)
Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including Chronic myelomonocytic leukemia (CMML), with evidence of active myeloproliferative features or myelofibrosis in the background.
Confirmed diagnosis of Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).