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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

Study Purpose

To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Signed written informed consent form (ICF) before any procedure related to the study.
  • - Newly diagnosed (≤ 3 months) BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase.
  • - Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2 (e14a2) - Not previously treated for CML except with hydroxyurea or anagrelide.
  • - ECOG Performance Status (ECOG PS) ≤ 2.
  • - Adequate organ function: Total bilirubin < 1,5 times the institutional Upper Limit of Normal (ULN); Hepatic enzymes ASAT and ALAT < 2 times the institutional ULN; Serum Creatinine < 1.5 time the institutional ULN; Lipase < 1.5 time the institutional ULN.
  • - Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
  • - WOCBP must have a negative serum or urine pregnancy test at screening.
  • - Free subject, without guardianship nor subordination.
  • - Health insurance coverage.

Exclusion Criteria:

  • - Patients with BCR-ABL transcript other than M-BCR-ABL.
  • - Patients previously treated with tyrosine kinase inhibitors (TKIs).
  • - Inability to freely provide consent through judiciary or administrative condition.
  • - Ongoing participation to another clinical investigational study.
  • - Medical history and concurrent diseases: a) Hypersensitivity to any of the excipients of BOS or RoPegIFN, b) Prior treatment with Interferon-α, contraindication to interferon-α, c) Autoimmune disorder, concomitant immunosuppressive treatment or corticosteroids, d) Pre-existing thyroid disease unless controlled with conventional treatment, auto-immune thyroiditis, e) Chronic liver disease, f) Prior or ongoing severe psychiatric disease, g) HIV positivity, chronic hepatitis B or C, h) Uncontrolled or severe cardiac (NYHA Class III or IV) or pulmonary disease, echocardiography with LVF < 45% or LLN, peak velocity of tricuspid regurgitant flow > 2,8 m/s, pulmonary arterial hypertension (PAH), QTc>450 ms (by Barrets correction) - Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix, - History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder, - Subjects with an uncontrolled undercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
  • - Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4, - History / any condition for poor compliance to medical treatment.
- Women who are pregnant or breastfeeding are not eligible for this study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03831776
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

St. Olavs Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tom Christian Martinsen, md phdHenrik Hjorth-Hansen, md phdLydia Roy, md phd
Principal Investigator Affiliation St Olavs Hospital, Clinical of Internal MedicineSt. Olavs HospitalCentre Hospitalo-Universitaire Henri Mondor, Service d'Hematologie Clinique
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark, Finland, Norway, Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Myeloid Leukemia
Arms & Interventions

Arms

Experimental: Bosutinib-Ropeginterferon combination

Active Comparator: Bosutinib monotherapy

Interventions

Drug: - Bosutinib

Bosutinib, provided by Pfizer, starting dose of 200mg QD and stepwise dose escalation (> 300 mg/d > 400 mg/d) during the first three months. A pharmacological study will be performed in the French cohort (BOSUSTEP Substudy). BOS residual plasma concentration (Cmin) will be checked after initiation, before each dose step in the French cohort, and at M3 also for Nordic patients in ancillary studies.

Drug: - Ropeginterferon

Ro-Peg-Interferon α2b will be supplied by AOP Orphan to be administered by subcutaneous injections from prefilled injection pens. RoPegIFN will be given in an open-label fashion. Patients assigned to RoPegIFN will start with 50 μg injected subcutaneously every 14 days, in combination with Bosutinib.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aalborg university hospital, Aalborg, Denmark

Status

Not yet recruiting

Address

Aalborg university hospital

Aalborg, ,

Site Contact

Rie Sander Bech

henrik.hjorth-hansen@ntnu.no

0047 73598673

Aarhus ..., Aarhus, Denmark

Status

Not yet recruiting

Address

Aarhus ...

Aarhus, ,

Site Contact

Jesper Stentoft

henrik.hjorth-hansen@ntnu.no

0047 73598673

Copenhagen ..., Copenhagen, Denmark

Status

Not yet recruiting

Address

Copenhagen ...

Copenhagen, ,

Site Contact

Christen Lykkegård Andersen

henrik.hjorth-hansen@ntnu.no

0047 73598673

Odense Universitetshospital, Odense, Denmark

Status

Not yet recruiting

Address

Odense Universitetshospital

Odense, ,

Site Contact

Andreja Dimitrijevic

henrik.hjorth-hansen@ntnu.no

0047 73598673

Comprehensive Cancer Center, Hematology, Helsinki, Finland

Status

Not yet recruiting

Address

Comprehensive Cancer Center, Hematology

Helsinki, ,

Site Contact

Perttu M Koskenvesa

henrik.hjorth-hansen@ntnu.no

0047 73598673

Haukeland Universitetssjukehus, Bergen, Norway

Status

Recruiting

Address

Haukeland Universitetssjukehus

Bergen, ,

Site Contact

Bjørn Tore Gjertsen

henrik.hjorth-hansen@ntnu.no

0047 73598673

Oslo Universitetssykehus, Oslo, Norway

Status

Recruiting

Address

Oslo Universitetssykehus

Oslo, ,

Site Contact

Kristin H Låstad

henrik.hjorth-hansen@ntnu.no

0047 73598673

Stavanger Universitetssjukehus, Stavanger, Norway

Status

Recruiting

Address

Stavanger Universitetssjukehus

Stavanger, ,

Site Contact

Margrete Friestad

henrik.hjorth-hansen@ntnu.no

0047 73598673

Universitetssykehuset Nord Norge, Tromsø, Norway

Status

Recruiting

Address

Universitetssykehuset Nord Norge

Tromsø, ,

Site Contact

Mats I Olsen

henrik.hjorth-hansen@ntnu.no

0047 73598673

St Olavs Hospital, Trondheim, Norway

Status

Recruiting

Address

St Olavs Hospital

Trondheim, ,

Site Contact

Henrik Hjorth-Hansen, md phd

henrik.hjorth-hansen@ntnu.no

0047 73598673

Göteborg ...., Göteborg, Sweden

Status

Not yet recruiting

Address

Göteborg ....

Göteborg, ,

Site Contact

henrik.hjorth-hansen@ntnu.no

0047 73598673

Universitetssjukhuset Linköping, Linköping, Sweden

Status

Not yet recruiting

Address

Universitetssjukhuset Linköping

Linköping, ,

Site Contact

Kourosh Lotfi

henrik.hjorth-hansen@ntnu.no

0047 73598673

Skåne University Hospital, Lund, Sweden

Status

Not yet recruiting

Address

Skåne University Hospital

Lund, ,

Site Contact

Johan Richter

henrik.hjorth-hansen@ntnu.no

0047 73598673

Karolinska Universitetssjukhus, Stockholm, Sweden

Status

Not yet recruiting

Address

Karolinska Universitetssjukhus

Stockholm, ,

Site Contact

Leif Stenke

henrik.hjorth-hansen@ntnu.no

0047 73598673

Sundsvall ..., Sundsvall, Sweden

Status

Not yet recruiting

Address

Sundsvall ...

Sundsvall, ,

Site Contact

Anders Själander

henrik.hjorth-hansen@ntnu.no

0047 73598673

Norrlands Universitetssjukhus, Umeå, Sweden

Status

Not yet recruiting

Address

Norrlands Universitetssjukhus

Umeå, ,

Site Contact

Berit Markevärn

henrik.hjorth-hansen@ntnu.no

0047 73598673

University Hospital, Uppsala, Sweden

Status

Not yet recruiting

Address

University Hospital

Uppsala, ,

Site Contact

Ulla Olsson-Strömberg

henrik.hjorth-hansen@ntnu.no

0047 73598673

Universitetssjukhuset Örebro, Örebro, Sweden

Status

Not yet recruiting

Address

Universitetssjukhuset Örebro

Örebro, ,

Site Contact

Erik Ahlstrand

henrik.hjorth-hansen@ntnu.no

0047 73598673

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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