Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg (RUXOPeg)
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|ClinicalTrials.gov Identifier: NCT02742324|
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: Ruxolotinib Drug: peg-IFN alpha -2a||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Randomized Trial Combination of Ruxolitinib and Peg-interferon Alpha-2a in Patients With Primary Myelofibrosis Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Ruxolotinib and peg-IFN alpha -2a
LeveL 1 Ruxolotinib 10 mg BID and peg-IFN alpha -2a 45 mcg weekly increasing doses to level 9 : Ruxolotinib 20 mg BID and peg-IFN alpha -2a 135 mcg weekly
Ruxolotinib and peg-IFN alpha -2a randomized between selected doses from phase I
Ruxolitinib is administered orally twice a day (bid) everyday in 28-day treatment cycles. The starting dose is 10 mg BID and may go up to 20 mg BID. Ruxolotinib therapy starts on Cycle 1 day 1.
Other Name: Jakavi
Drug: peg-IFN alpha -2a
Peg-IFN-alpha-2a is administered subcutaneously once a week. The doses tested are 45, 90 and 135 mcg/week. .Peg-IFN-alpha-2a therapy starts at Cycle 1Day 15.Of note, Peg-IFN-alpha-2a will only be started if the platelet count is ≥ 50x109/L at C1D15.
Other Name: Pegasys
- 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
- molecular response [ Time Frame: 12 months ]molecular response measured by the evolution of JAK2V617F or CALR or MPL mutant allele burden during therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742324
|Contact: Jean Jacques KILADJIAN, MD PDfirstname.lastname@example.org|
|Contact: Valérie ROLLAND NEYRET, Mrs||+33476765096||VRollandemail@example.com|
|Principal Investigator:||Jean Jacques KILADJIAN, MD PD||FIM/GOELAMS|