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

NCT02742324 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-07-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ruxolotinib

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.

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.

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Jean Jacques KILADJIAN, MD PD · FIM/GOELAMS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-12-30
Completion
2021-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02742324 on ClinicalTrials.gov