A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

Novartis

Status and phase

Terminated

Phase 2

Conditions

Primary Myelofibrosis

Treatments

Drug: Ruxolitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02091752

CINC424A2407

Details and patient eligibility

About

The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria
Peripheral blast count < 10%
Requires therapy for MF in the opinion of the investigator
Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive weeks and experienced treatment interruption because of lossof response or adverse event
Patients adhering to the Screening phase assessments and undergoing a a ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks
ECOG performance status 0, 1, 2, or 3
Adequate bone marrow function
Written informed consent

Exclusion criteria

Patients not initially responding (primary resistance) to ruxolitinib therapy
Patients who underwent a splenectomy or spleen radiation
Patients currently scheduled for bone marrow transplant
Patients who have discontinued ruxolitinib < 14 days prior to screening
Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose
Leukemic transformation
Inadequate renal function
Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy
Previous history of Progressive Multifocal Leuko-encephalopathy (PML)
Clinically significant cardiac disease or significant concurrent medical condition