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)
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Myelofibrosis
Intervention: Ruxolitinib (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
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.
Clinical Details
Official title: The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 20% from baseline, by Week 24
Secondary outcome: The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 35% from baseline, by Week 24The effect of re-treatment with ruxolitinib on reduction in spleen length of at least 25% and 50% respectively, from baseline, by Week 24 The effect of re-treatment with ruxolitinib on reduction in spleen volume and length over time The safety after re-treatment with ruxolitinib The effect of re-treatment with ruxolitinib on reduction in MPN-SAF TSS of at least 25% and 50% respectively, from baseline, by Week 24 The effect of re-treatment with ruxolitinib on reduction in MPN-SAF TSS over time The effect of re-treatment with ruxolitinib on Patient Global Impression of Change (PGIC) The effect of re-treatment with ruxolitinib on EORTC QLQ-C30 and EQ-5D-5L
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Novartis Investigative Site, Leipzig 04103, Germany
Novartis Investigative Site, Madrid 28034, Spain
Novartis Investigative Site, Salamanca, Castilla y Leon 37007, Spain
Novartis Investigative Site, Firenze, FI 50134, Italy
Additional Information
Starting date: September 2014
Last updated: March 31, 2015
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