AzTrials
AzTrials

MyelofibrosisPhase 1/2RUXOPegNCT02742324

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

A Phase 1/2 study testing Ruxolotinib and peg-IFN alpha -2a in people with Myelofibrosis, run by French Innovative Leukemia Organisation at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Myelofibrosis
What is being tested?
Ruxolotinib and peg-IFN alpha -2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteFrance
Study dates
Mar 2016to 31 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study have to meet all of the following criteria:
  • Age > 18 years and < 66 years
  • Diagnosis of primary or secondary myelofibrosis according to the 2008 World Health Organization (WHO) criteria for PMF (Tefferi and Vardiman 2008) and the proposed criteria for PPV-MF and PET-MF outlined by the International Working Group for Myelofibrosis Research and Treatment (Barosi et al 2008)
  • Patients classified as high risk, OR intermediate risk-2, OR intermediate risk-1, as defined by the International Working Group, IWG (Cervantes, et al 2009) at diagnosis (or by the DIPSS (Passamonti et al. 2010) for patients assessed after diagnosis of PMF)
  • Need for active therapy, defined as presence of at least one of the following:
  • symptomatic splenomegaly
Show all 20Show fewer
  • presence of constitutional symptoms
  • anemia (Hb< 10g/dl)
  • leukocytosis > 25 G/l
  • thrombocytosis > 400 G/l
  • Presence of JAK2V617F , Calreticulin or MPL mutations
  • Platelet counts ≥ 150 x 109/L not reached with the aide of transfusions at screening
  • Patients with ANC ≥ 1.5 x 109/L at screening without the use of G-CSF
  • Peripheral blood blast count of ≤ 10% at Screening
  • ECOG performance status of 0, 1, or 2 at Screening
  • Negative serological Hepatitis B test (i.e. HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative); negative testing of Hepatitis C RNA; negative HIV test within 6 weeks prior to registration.
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at Screening and effective contraception's method during the study and 75 days after the last dose.
  • Informed consent sign
  • Patients without Social Security coverage
  • Patient who is not included into another clinical study until 1 month after the end of this study

Who cannot join

  • ANC < 1.5 G/l or platelets < 150 G/l
  • > 10% circulating blasts
  • Contra-indication to IFN alpha or to ruxolitinib
  • Patients previously treated with IFN alpha or a JAK2 inhibitor
  • Documented autoimmune disease at screening or in the medical history
  • History or presence of depression requiring treatment with antidepressant
Show all 31Show fewer
  • Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
  • Thyroid dysfunction not adequately controlled
  • Women of childbearing potential who have a positive serum pregnancy test at screening or who cannot or do not wish to use an effective method of contraception, during treatment and for 75 days after the last dose of study drug.
  • Pregnant or nursing (lactating) women
  • Patients with known active hepatitis B or C or with known HIV positivity
  • Patient with a concurrent malignancy or malignancy within 3 years of Screening, with the exception of adequately treated basal or squamous cell carcinoma, non melanomatous skin cancer or curatively resected cervical cancer.
  • Patient has a history of cardiac dysfunction including any of the following:
  • Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patient has active cardiac disease including any of the following:
  • Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated Acquisition (MUGA) or echocardiogram (ECHO)
  • QTc> 480 msec on screening ECG (QTcF, using the Fridericia formula)
  • Angina pectoris that requires the use of anti-anginal medication
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
  • Conduction abnormality requiring a pacemaker
  • Valvular disease with documented compromise in cardiac function
  • Symptomatic pericarditis
  • Patients with inadequate liver or renal function at Screening as demonstrated by:
  • encephalopathy grade 1 or more, as per West Haven Criteria
  • known hepatocellular disease (e.g. active hepatitis or cirrhosis)
  • total bilirubin> 2 x ULN and subsequent determination of direct bilirubin > 2 x ULN alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2 x ULN
  • MDRD-eGFR< 45 mL/min/1.73m2 or on dialysis
  • Patients who currently are willing candidates for a stem cell transplantation at the time of the screening assessments

Trial locations and contacts

1 site in 1 country.

France1 site

  • FILO French Innovative Leukemia Organization

    Tours, 37044

Other trials in France

About this study

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

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.

Read the 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 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.

Conditions
Myelofibrosis
Being tested
Ruxolotinib, peg-IFN alpha -2a
Keywords
efficacy, safety
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolotinibDrug

    Also called Jakavi

    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.

  • peg-IFN alpha -2aDrug

    Also called Pegasys

    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.

Study groups in NCT02742324
Study groupRoleWhat they receive
Ruxolotinib and peg-IFN alpha -2aExperimentalPhase I 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 Phase II Ruxolotinib and peg-IFN alpha -2a randomized between selected doses from phase I
Receives: Drug: Ruxolotinib; Drug: peg-IFN alpha -2a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. study treatment efficacy/safety phase I

    Phase 1 tolerance criterion : Occurrence of dose limiting toxicities DLT within the first 45 days

    Measured: day 45

  2. study treatment efficacy/safety phase II

    Phase II Efficacy criterion: Occurrence of at least 50% reduction in spleen length as measured by palpation within the first 6 months after randomization

    Measured: month 6

Secondary outcomes (1)

  1. molecular response

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion30 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02742324
Sponsor's protocol ID
RUXOPeg
Acronym
RUXOPeg
Status last verified
Jul 2022
First submitted
8 Mar 2016
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: e crf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ruxolotinib and peg-IFN alpha -2a in people with Myelofibrosis, run by French Innovative Leukemia Organisation at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

study treatment efficacy/safety phase I (time frame: day 45). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02742324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in