Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02742324
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2016-03-08
Brief Title:
Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
Phase 12 Randomized Trial Combination of Ruxolitinib and Peg-interferon Alpha-2a in Patients With Primary Myelofibrosis Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RUXOPeg
Brief Summary:
Phase 12 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 Description:
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 12 adaptively randomized design proposed by Yuan and Yin 2011 for combined drugsThe 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 mcgweek 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
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 12 adaptively randomized design proposed by Yuan and Yin 2011 for combined drugsThe 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 mcgweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None