Clinical Trial: 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)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 R
Brief 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume [ Time Frame: Week 24 ]
Original Primary Outcome: The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 20% from baseline, by Week 24 [ Time Frame: Up to Week 24 ]
Current Secondary Outcome:
- Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume [ Time Frame: Week 24 ]
- Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length [ Time Frame: Week 24 ]
- Change From Baseline in Spleen Length and Spleen Volume [ Time Frame: Baseline, Week 24 ]
- Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS) [ Time Frame: Week 24 ]
- Change From Baseline in MPN-SAF TSS Score [ Time Frame: Baseline, Week 24 ]
- Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 1, Week 24 ]
- Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores [ Time Frame: Baseline, Day 1, Week 8, Week 12, Week 16, Week 24 ]
Original Secondary Outcome:
- The effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 35% from baseline, by Week 24 [ Time Frame: By Week 24 ]Proportion of patients achieving ≥35% reduction from baseline in spleen volume by Week 24 after re-treatment with ruxolitinib
- The effect of re-treatment with ruxolitinib on reduction in spleen length of at least 25% and 50% respectively, from baseline, by Week 24 [ Time Frame: By Week 24 ]Proportion of patients achieving ≥25% and ≥50% reduction respectively, from baseline, in spleen length by Week 24 after re-treatment with ruxolitinib
- The effect of re-treatment with ruxolitinib on reduction in spleen volume and length over time [ Time Frame: Up to Week 24 ]Change in spleen length as well as in spleen volume from baseline to each visit where measured after re-treatment with ruxolitinib
- The safety after re-treatment with ruxolitinib [ Time Frame: Up to Week 24 ]Safety will be assessed by monitoring the frequency, duration and severity of Adverse Events, and evaluating changes in vital signs, electrocardiograms (ECGs), serum chemistry, hematology and urinalysis results.
- 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 [ Time Frame: By Week 24 ]Proportion of patients achieving ≥25% and ≥50% reduction respectively, from baseline in total symptom score (MPN-SAF TSS) by Week 24 after re-treatment with ruxolitinib
- The effect of re-treatment with ruxolitinib on reduction in MPN-SAF TSS over time [ Time Frame: Up to Week 24 ]Change in MPN-SAF TSS from baseline to each visit where measured after re-treatment with ruxolitinib
- The effect of re-treatment with ruxolitinib on Patient Global Impression of Change (PGIC) [ Time Frame: By Week 1 to Week 24 ]PGIC at each visit where measured after retreatment with ruxolitinib
- The effect of re-treatment with ruxolitinib on EORTC QLQ-C30 and EQ-5D-5L [ Time Frame: At Day 1, Week 8, Week 12, Week 16, Week 24 ]Change in EORTC QLQ-C30 and EQ-5 D-5L scores from baseline to each visit where measured after re-treatment with ruxolitinib
Information By: Novartis
Dates:
Date Received: March 6, 2014
Date Started: September 2014
Date Completion:
Last Updated: February 24, 2016
Last Verified: February 2016