Ruxolitinib in Combination With Autotransplant

Description

To determine the safety of the approach of giving RUXOLITINIB before and after an autologous stem cell transplant, as measured by graft failure or death.

Study Start Date

May 2015

Estimated Completion Date

May 2020

Interventions

  • Drug: RUXOLITINIB / INC 424
  • Drug: Busulfan
  • Drug: Filgrastim

Specialties

  • Internal Medicine: Hematology/Oncology
  • Nursing: Hematology/Oncology
  • Oncology: BMT/SCT,Myeloproliferative Dz,Pharmacology/Therapy
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Bone Marrow Diseases
  • Myeloproliferative Disorders
  • Primary Myelofibrosis

Study ID

Mount Sinai School of Medicine -- GCO 14-2106

Status

Unknown

Trial ID

NCT02469974

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

10

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • Histologically documented diagnosis of MF (idiopathic or post PV/ET)
  • Age 18-75 years
  • Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) criteria or Intermediate-1 risk disease with one of the following features within one year from screening: 1. Red cell transfusion dependency 2. unfavorable Karyotype 3. platelet count <100 x 109/L 4. symptomatic splenomegaly 5. PB blasts > 1% 6. Blasts in PB <20% prior to study enrollment 7. No available suitable matched related (6/6 or 5/6) or unrelated donor (8/8 or 7/8 allele matched) or unwilling or unable to pursue allogeneic stem cell transplant 8. WBC <50,000/ml at screening
  • Able to give informed written consent
  • ECOG Performance status of 0-2
  • Life expectancy >6 months
  • Off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least 4 weeks prior to study enrollment and recovered from all toxicities. If patient is already on ruxolitinib for a minimum of 16 weeks prior to study enrollment, patient can proceed to mobilization and collection
  • Adequate organ function defined as the following (*unless clearly disease related): 1. Adequate renal function
  • creatinine <2 x ULN 2. Adequate hepatic function
  • AST/ALT <3 x ULN, Total Bilirubin <3 x ULN, exception is elevated indirect bilirubin attributed to Gilbert's syndrome or hemolysis 3. Adequate hematopoietic function
  • Platelet ?50 x 109/L (without transfusion) and ANC ?1.0 x 109/L 4. LVEF >40% (MUGA or echocardiogram) 5. Adequate pulmonary function with DLCO >40%

Exclusion Criteria

  • Hypersensitivity to JAK inhibitor
  • Clinical evidence of cirrhosis
  • Leukemic transformation (>20% blasts in PB or BM any time prior to HCT)
  • Platelet count <50 x 109/L
  • Active uncontrolled infection
  • History of another malignancy within 5-years of date of HCT except history of basal cell or squamous cell carcinoma of skin or PV or ET
  • Known HIV positive
  • Woman of childbearing potential unwilling or unable to use adequate contraception Pregnant or nursing females Known active infection with hepatitis A, B or C virus

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Marina Kremyanskaya MD PhD 212-241-4106 marina.kremyanskaya@mssm.edu

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