Clinical Trial: Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 1/2 Randomized Trial Combination of Ruxolitinib and Peg-interferon Alpha-2a in Patients With Primary Myelofibrosis Post-polycythemia Vera-myelo

Brief Summary: Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose combination that also satisfies certain safety requirements. It consists in a dose finding study to assess the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients.

Detailed Summary:

Part 1 is a dose finding phase 1 trial that assesses the safety of the combination of different doses of both ruxolitinib and peg-IFN alpha-2a

Part 2 is a phase 2 randomized evaluation of the optimal doses found in the first part of the study to a total maximal number of 42 evaluable patients.

It will use the Bayesian Phase 1/2 adaptively randomized design proposed by Yuan and Yin (2011) for combined drugs.The trial will examine three doses of ruxolitinib: 10, 15 and 20 mg BID and three doses of the peg-IFN alpha-2a: 45, 90, and 135 mcg/week). The starting doses for each drug have been selected based on prior monotherapy experience where these doses have shown some degree of clinical activity as single agents and pharmacodynamic data supports the activity observed. In the interest of patient safety, both of these compounds will start at dose levels at or near 50% of their respective maximum tolerated doses.


Sponsor: French Innovative Leukemia Organisation

Current Primary Outcome:

  • study treatment efficacy/safety phase I [ Time Frame: day 45 ]
    Phase 1 tolerance criterion : Occurrence of dose limiting toxicities DLT within the first 45 days
  • study treatment efficacy/safety phase II [ Time Frame: month 6 ]
    Phase II Efficacy criterion: Occurrence of at least 50% reduction in spleen length as measured by palpation within the first 6 months after randomization


Original Primary Outcome: Same as current

Current Secondary Outcome: molecular response [ Time Frame: 12 months ]

molecular response measured by the evolution of JAK2V617F or CALR or MPL mutant allele burden during therapy


Original Secondary Outcome: Same as current

Information By: French Innovative Leukemia Organisation

Dates:
Date Received: March 8, 2016
Date Started: March 2016
Date Completion: October 2018
Last Updated: October 25, 2016
Last Verified: October 2016