Phase Ib/II clinical trial of ruxolitinib in combination with nilotinib and prednisona for myelofibrosis: RuNiC study - RuNiC

Grupo Español de Enfermedades Mieloproliferativas GEMFI0 sites44 target enrollmentMay 29, 2017

ConditionsMyeloproliferative Diseases MedDRA version: 20.0Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

DrugsJakavi Tasigna

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myeloproliferative Diseases
Sponsor: Grupo Español de Enfermedades Mieloproliferativas GEMFI
Enrollment: 44
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 29, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Grupo Español de Enfermedades Mieloproliferativas GEMFI

Eligibility Criteria

Inclusion Criteria

•Patients are included in the study if all of the following criteria are met:
•1\.Patients must be 18 years or older.
•2\.Patients must be diagnosed with primary myelofibrosis (PMF), post\-polycythemia vera myelofibrosis (PPV\-MF) or post\-essential thrombocythemia\-myelofibrosis (PET\-MF) irrespective of JAK2 mutation status, guided by the criteria outlined in the 2008 World Health Organization (WHO) criteria for PMF9 and the proposed criteria for PPV\-MF and PET\-MF outlined by the International Working Group for Myelofibrosis Research and Treatment (IWG\-MRT)10\.
•3\.Patient must be classified as at least intermediate risk level 1 (1 or more prognostic factors) with at least one criteria other than age. The prognostic factors, defined by the International Working Group are11:
•?Age \> 65 years.
•?Presence of constitutional symptoms (weight loss \> 10% in the year preceding the screening visit, unexplained fever, or excessive night sweats persisting for more than 1 month).
•?Marked anemia (hemoglobin \< 10g/dL)\*.
•?Leukocytosis (history of white blood cell count \> 25 x109/L).
•?Circulating blasts \= 1%.
•\*A hemoglobin value \< 10 g/dL must be demonstrated during the screening for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin \< 10 g/dL for the purpose of evaluation of risk factors.

Exclusion Criteria

•Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
•\-Women of child\-bearing potential.
•\-Male sterilization (at least 6 months prior to screening).
•\-For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
•.Previous treatment with JAK inhibitors (including ruxolitinib \[INC424]) that resulted in clinically significant toxicities at the discretion of the investigator.
•Patient with clinically significant bacterial, fungal, parasitic or viral infection which require therapy at screening. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
•Patients with known active hepatitis B or C or with known HIV positivity (testing is not mandatory).
•Patients with impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of ruxolitinib, nilotinib and prednisone at screening (e.g. uncontrolled nausea, vomiting, diarrhea, mal\-absorption syndrome, small bowel resection).
•Patient with a concurrent malignancy or malignancy within 3 years of screening, with the exception of adequately treated basal or squamous cell carcinoma, non\-melanomatous skin cancer or curatively resected cervical cancer.
•Patient who has not recovered to grade 1 or better from any AEs (except alopecia, fatigue, nausea, vomiting) related to previous antineoplastic therapy before screening procedures are initiated.