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Primary MyelofibrosisPhase 2NCT05467800

Study of Canakinumab in Patients With Myelofibrosis

A Phase 2 study testing Canakinumab in people with Primary Myelofibrosis and Post-essential Thrombocythemia Myelofibrosis, run by John Mascarenhas at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open label, multicenter, phase 2 trial of Canakinumab in patients with primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Canakinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
7 sitesUnited States
Study dates
2 Aug 2022to 1 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following are required for inclusion in the study:
  • Parts 1 and 2:
  • Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements.
  • Participants must be ≥ 18 years of age at the time of signing the ICF.
  • Participants must have a pathologically confirmed diagnosis of PMF as per the World Health Organization (WHO) diagnostic criteria46 or post-ET MF or post-PV MF according to IWG-MRT criteria.47
  • Participants must have at least one of the following:
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  • Hemoglobin < 10 g/dL
  • Transfusion-dependency (at least 6 units of packed red blood cells (PRBC) in the 12 weeks prior to study enrollment, for a hemoglobin < 8.5 g/dL, in the absence of bleeding or treatment-induced anemia with the most recent transfusion having occurred in the 28 days prior to study enrollment)
  • Splenomegaly palpated ≥ 5 cm below the left costal margin (LCM) or spleen volume ≥ 450 cc
  • MFSAF v4.0 TSS ≥ 10
  • A bone marrow biopsy must be performed within the 30-day screening period; however, a bone marrow biopsy obtained within 90 days of signing ICF without intervening treatments and approved by the study chair may suffice.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
  • Life expectancy of at least 6 months.
  • Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments excluding alopecia.
  • Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 28 days of starting the study drug. Men and women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence, tubal ligation, vasectomy) prior to Cycle 1 Day 1 and for 130 days after stopping study treatment. Vasectomy must be performed a minimum of 3 months before study start.
  • Must have adequate organ function as demonstrated by the following:
  • ALT/AST ≤ 3.0 x ULN, or ≤ 4 x ULN (unless if upon judgment of the treating physician, it is believed to be due to EMH related to MF);
  • Direct bilirubin ≤ 1.5 x ULN or ≤ 2.0 x ULN (unless if upon judgment of the treating physician, it is believed to be due to EMH related to MF or documented Gilbert's syndrome);
  • Serum creatinine ≤ 2.0 mg/dL;
  • Platelet count ≥ 25 x 109/L (participant must not have had platelet transfusion in the 14 days prior to signing ICF);
  • ANC ≥ 1000/µL
  • Participant must be willing to receive red blood cell and/or platelet transfusions if indicated.
  • Bone marrow and peripheral blood blast count < 10%.
  • Part 1 Only:
  • At least two weeks must have elapsed between the last dose of any MF-directed drug treatments (including investigational therapies and excluding hydroxyurea) and study enrollment.
  • Not eligible for available, approved JAKi therapy due to a platelet count of < 50 x 109/L or previously treated and lack/loss of response per investigator discretion.
  • Part 2 Only:
  • Current treatment with a JAKi (inclusive of ruxolitinib, fedratinib, momelotinib, or pacritinib) for at least 16 weeks and on a stable or decreased dose for at least 12 weeks prior to study enrollment.

Who cannot join

  • Any of the following is a criterion for exclusion from the study:
  • Prior malignancy active within the previous ≤ 1 year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Any of the following cardiac abnormalities
  • Uncontrolled, symptomatic congestive heart failure as designated by the treating physician
  • Myocardial infarction ≤ 6 months prior to enrollment
  • Unstable angina pectoris designated by treating physician
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  • Serious uncontrolled cardiac arrhythmia as designated by treating physician
  • Uncontrolled hypertension as designated by treating physician
  • Known history of human immunodeficiency virus (HIV) (no laboratory testing is required), or active infection with hepatitis B or Hepatitis C.
  • Active TB infection or documented, untreated latent TB infection (all participants should undergo TB risk evaluation prior to enrollment with TB screening performed as per local guidelines.)
  • Active, uncontrolled infection at the time of enrollment, except in cases of localized infections that are unlikely to lead to a systemic infection such as onychomycoses or dental caries.
  • Participants with a new fever (T>38.0o C) or respiratory symptoms are required to undergo laboratory screening for COVID-19.
  • Have undergone prior allo-HSCT for treatment of any hematological disorder or prior solid organ transplant
  • Any serious or uncontrolled psychiatric or medical disorder that, in the opinion of the investigator, may increase the risk associated with the study participation or study drug administration, impair the ability of the participants to receive protocol therapy, or interfere with the interpretation of study results.
  • Women who are pregnant or breastfeeding.
  • Participants undergoing concurrent treatment with agents targeting TNF-α or IL-1 within 28 days of study enrollment.
  • Participants who have received a live vaccination within 90 days before study drug administration (participants should not be treated with live-virus vaccine while undergoing therapy and 130 days after Canakinumab discontinuation).
  • Participants with a condition requiring systemic treatment with corticosteroids within 14 days of study drug administration (i.e. prednisone at doses of > 10 mg). Inhaled or topical steroids and adrenal/pituitary replacement doses ≤ 10mg daily of prednisone or equivalent are permitted.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Ruttenberg Treatment Center

    New York, New York, 10029

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • The University of Kansas Cancer Center-Westwood

    Westwood, Kansas, 66205

  • Wake Forest Baptist Health Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase 2 Study of Canakinumab in Patients With Myelofibrosis Myeloproliferative Neoplasms Research Consortium [MPN-RC 122]

This is an open label, multicenter, phase 2 trial of Canakinumab in patients with primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF). Eligible patients will receive Canakinumab administered as a subcutaneous injection on day 1 of a 21 day cycle for a core study period of 8 cycles. Canakinumab will be given by subcutaneous injection (SC) injection at a starting dose of 200 mg (one 150 mg/mL syringe and one 50 mg/0.5 mL syringe) every 3 weeks. The interim analysis will be performed when the number of enrolled patients reaches 10. If no responses OR 4 or more patients have unacceptable toxicity, the study will not proceed to the second stage. If the total number of patients reaches the maximum sample size of 26, the treatment is deemed acceptable if the number of responses in the efficacy endpoint are greater than 3, and the number of toxicities are less than 7.

Being tested
Canakinumab
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • CanakinumabDrug

    Canakinumab administered as a subcutaneous injection on day 1 of a 21 day cycle for a core study period of 8 cycles.

Study groups in NCT05467800
Study groupRoleWhat they receive
CanakinumabExperimentalCanakinumab will be given by subcutaneous injection (SC) injection at a starting dose of 200 mg (one 150 mg/mL syringe and one 50 mg/0.5 mL syringe) every 3 weeks.
Receives: Drug: Canakinumab

What is being measured

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

  1. Number of participant with response based on IWG-MRT criteria

    Efficacy of Canakinumab as measured by number of participant with response based on the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria. A response is considered any one of the following: complete response, partial response, or clinical improvement (inclusive of anemia response, spleen response, or symptom response).

    Measured: 24 weeks

Secondary outcomes (10)

  1. Number of Adverse Events

    The safety and tolerability of Canakinumab as measured by the adverse event profile of Common Terminology Criteria for Adverse Events version 5.0

    Measured: 24 weeks

  2. Response using IWG-MRT

    To assess the efficacy of Canakinumab as determined by response assessment using IWG/ELN criteria. Participant's response will be categorized as negative, stable, or positive.

    Measured: 12 weeks

  3. Response using IWG-MRT

    To assess the efficacy of Canakinumab as determined by response assessment using IWG/ELN. Participant's response will be categorized as negative, stable, or positive.

    Measured: 24 weeks

  4. Number of participants with clinical improvement

    Clinical improvement (CI) is defined by IWG-MRT criteria. Participants meet CI if meet any of the following:

    Anemia (Patients will meet IWG-MRT criteria for clinical improvement if their hemoglobin increase by 2g/dl from baseline and/or become transfusion independent.)

    Splenomegaly (Patients will meet IWG-MRT criteria for clinical improvement if their spleen decreases by ≥30% from baseline volume.)

    Disease-related symptoms (Patients will meet IWG-MRT criteria for clinical improvement if their MPN-SAF symptom score decreases by ≥50% from baseline)

    Measured: 12 weeks

  5. Number of participants with clinical improvement

    Clinical improvement (CI) is defined by IWG-MRT criteria. Participants meet CI if meet any of the following:

    Anemia (Patients will meet IWG-MRT criteria for clinical improvement if their hemoglobin increase by 2g/dl from baseline and/or become transfusion independent.)

    Splenomegaly (Patients will meet IWG-MRT criteria for clinical improvement if their spleen decreases by ≥30% from baseline volume.)

    Disease-related symptoms (Patients will meet IWG-MRT criteria for clinical improvement if their MPN-SAF symptom score decreases by ≥50% from baseline)

    Measured: 24 weeks

  6. Change in Spleen Volume

    Change in Spleen Volume as compared to baseline

    Measured: 12 weeks

  7. Change in Spleen Volume

    Change in Spleen Volume as compared to baseline

    Measured: 24 weeks

  8. Overall Survival (OS)

    OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).

    Measured: 24 weeks

  9. Progression free survival (PFS)

    PFS is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier.

    Measured: 12 weeks

  10. Progression free survival (PFS)

    PFS is defined as the duration of time from start of treatment to the first occurrence of disease progression or death on study from any cause, whichever occurs earlier.

    Measured: 24 weeks

Timeline

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

  1. First posted21 Jul 2022
  2. Study start2 Aug 2022
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467800
Sponsor's protocol ID
GCO 22-0543
Other IDs
MPN-RC 122
Status last verified
May 2026
First submitted
18 Jul 2022
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canakinumab in people with Primary Myelofibrosis and Post-essential Thrombocythemia Myelofibrosis, run by John Mascarenhas at 7 sites in United States.

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 28 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Number of participant with response based on IWG-MRT criteria (time frame: 24 weeks). 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 NCT05467800.

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 7 May 2026.

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