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MPN (Myeloproliferative Neoplasms)Phase 2NCT03011372

A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

A Phase 2 study testing Pemigatinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 33 sites in 11 countries.

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

The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MPN (Myeloproliferative Neoplasms)
What is being tested?
Pemigatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
33 sitesin 11 countries
Study dates
25 Apr 2017to 30 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
  • Eligible subjects must:
  • Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
  • Not be current candidates for stem cell transplantation or other disease modifying therapies.
  • Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
  • Life expectancy ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Who cannot join

  • Prior receipt of a selective FGFR inhibitor.
  • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
  • Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
  • Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.

Trial locations and contacts

33 sites in 11 countries.

33 sites in 11 countries

United States9 sites

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Md Anderson Cancer Center

    Houston, Texas, 77030

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Weill Cornell Medical Centers

    New York, New York, 10021

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • University of Utah

    Salt Lake City, Utah, 84112

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Institute

    Stanford, California, 94305

Other trials in United States

Germany6 sites

  • University Medical Center Rwth Aachen

    Aachen, D-52074

  • Universitatsklinikum Halle (Saale)

    Halle, 06120

  • Universitatsklinikum Jena

    Jena, 07740

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • University Hospital Mannheim

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

Other trials in Germany

France4 sites

  • Centre Leon Berard

    Lyon, 69373

  • Chu de Nice - Hospital L Archet

    Nice, 06202

  • Hospital Saint Louis

    Paris, 75475

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    Toulouse, 31059

Other trials in France

Austria3 sites

  • Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

    Linz, 04010

  • Medical University of Vienna

    Vienna, 01090

  • Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus

    Vienna, 01140

Other trials in Austria

Italy2 sites

  • Ospedale Papa Giovanni Xxiii

    Bergamo, 24127

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134

Other trials in Italy

Japan2 sites

  • Kindai University Hospital

    Osaka, 589-8511

  • Ntt Medical Center Tokyo

    Tokyo, 141-8625

Other trials in Japan

Switzerland2 sites

  • Inselspital - Universitaetsspital Bern

    Bern, 03010

  • Universitatsspital Zurich

    Zurich, 08091

Other trials in Switzerland

United Kingdom2 sites

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT

  • Oxford University Hospitals Nhs Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Belgium1 site

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000

Other trials in Belgium

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Spain1 site

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

Being tested
Pemigatinib
Keywords
Myeloid neoplasm, fibroblast growth factor receptor inhibitor, FGFR1 rearrangement, 8p11, eosinophilia, eosinophilic syndrome, Lymphoid neoplasm
Medical subject headings
Myeloproliferative Disorders, Eosinophilia

What participants receive

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

  • PemigatinibDrug

    Also called INCB054828

    Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.

    Participants will receive either the intermittent dose (as written) or continuous dosing.

Study groups in NCT03011372
Study groupRoleWhat they receive
PemigatinibExperimentalNot described
Receives: Drug: Pemigatinib

What is being measured

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

  1. Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

    CR was defined as the presence of all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (Grade 1 or less fibrosis); (3) peripheral blood: white blood cells (WBC) ≤10 x 10^9 cells/Liter (L); hemoglobin (Hgb) ≥11 grams per deciliter (g/dL); platelets ≥100 x 10^9/L and ≤450 x 10^9/L; neutrophils ≥1.0 x 10^9/L; blasts = 0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10^9/L; eosinophils ≤0.5 x 10^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present before therapy (e.g., lymphadenopathy), including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted given subjectivity of assignment of dysplasia. Response criteria by investigator assessment were the same for chronic phase (CP) and blast phase (BP).

    Measured: up to 2513 days (120 21-day treatment cycles)

Secondary outcomes (10)

  1. Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

    CR=all of the following improvements: (1) bone marrow: ≤5% myeloblasts (including monocytic blast equivalent) and no lymphoblasts, with normal maturation of all cell lines, and return to age-adjusted normal cellularity; (2) osteomyelofibrosis absent/equal to "mild reticulin fibrosis"; (3) WBC ≤10 x 10^9 cells/L; Hgb ≥11 g/dL; platelets ≥100 x 10^9/L, ≤450 x 10^9/L; neutrophils ≥1.0 x 10^9/L; blasts=0%; neutrophil precursors reduced to ≤2%; monocytes ≤1 x 10^9/L; eosinophils ≤0.5 x 10^9/L; (4) extramedullary disease: complete resolution of extramedullary disease present pre-therapy, including palpable hepatosplenomegaly. Persistent low-level dysplasia was permitted. PR=all of the following improvements: (1) reduction of bone marrow blasts/blast equivalents by 50%, but remaining >5% of cellularity (except in cases with ≤5% bone marrow blasts at baseline); (2) normalization of peripheral blood indices per CR Criterion 3; (3) extra medullary disease response of CMR/CR or PMR/PR.

    Measured: up to 2513 days (120 21-day treatment cycles)

  2. Percentage of Participants Who Achieved a Complete Cytogenetic Response (CCyR) as Assessed by Local Analysis and Investigator Evaluation

    CCyR was defined as 0% 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or fluorescence in situ hybridization (FISH). Loss of cytogenetic burden of disease (via FISH or classic karyotyping) was required to reach CCyR.

    Measured: up to 2513 days (120 21-day treatment cycles)

  3. Percentage of Participants Who Achieved a Partial Cytogenetic Response (PCyR) as Assessed by Local Analysis and Investigator Evaluation

    PCyR was defined as the decrease from baseline of 50% or more 8p11 translocated metaphases as seen on classic karyotyping with minimal of 20 metaphases, or FISH.

    Measured: up to 2513 days (120 21-day treatment cycles)

  4. Percentage of Participants Who Achieved a PCyR as Assessed by CRC Assessment

    In addition, responses were assessed by CRC based on MLN IWG response criteria for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.

    Measured: up to 2513 days (120 21-day treatment cycles)

  5. Duration of Complete Response

    Duration of complete response was defined as the time from the first assessment of complete response to the earlier of the date of first worsening assessment after complete response or death due to any cause

    Measured: up to 2513 days (120 21-day treatment cycles)

  6. Duration of Response

    Duration of response was defined as the time from the first assessment of complete response or partial response to the earlier of the date of first worsening assessment after response or death due to any cause.

    Measured: up to 2513 days (120 21-day treatment cycles)

  7. Progression-free Survival (PFS)

    PFS was defined as the time from the first date of taking study drug until the date of disease progression or until death due to any cause, whichever was earlier. Disease progression was defined as the combination of 2 major criteria, 1 major and 2 minor criteria, or 3 minor criteria from the following lists. Major criteria: (1) increase in blast count; (2) evidence of cytogenetic evolution (re-appearance of a previously present or appearance of a new cytogenetic abnormality, or increase in cytogenetic burden of disease); (3) new or worsening extramedullary disease (worsening splenomegaly or extramedullary disease outside of the spleen). Minor criteria: (1) transfusion dependence; (2) significant loss of maximal response on cytopenias ≥50% decrement from maximum remission/response in granulocytes or platelets; (3) reduction in Hgb by ≥1.5g/dL from best response or from baseline as noted on complete blood count; (4) evidence of clonal evolution (molecular).

    Measured: up to 2513 days (120 21-day treatment cycles)

  8. Overall Survival

    Overall survival was defined as as the time from the first day of taking study drug until death due to any cause

    Measured: up to 2513 days (120 21-day treatment cycles)

  9. Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.

    Measured: up to 2543 days

  10. Number of Participants With Any ≥Grade 3 TEAE

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

    Measured: up to 2543 days

Timeline

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

  1. First posted5 Jan 2017 (estimated)
  2. Study start25 Apr 2017
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

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
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011372
Sponsor's protocol ID
INCB 54828-203
Other IDs
2016-002596-10, 2016
Status last verified
Nov 2025
First submitted
4 Jan 2017
Last updated
18 Nov 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Expanded access
Available

Publications

  • Al-Bazaz M, Forstreuter A, Hammada I, Hille J, Wagner JN, Reinert J, Wehrhahn J, Bokemeyer C, Fiedler W. Acute Lymphoblastic Leukemia Characterized by Rare BCR::FGFR1 Translocation: A Case Report With Literature Review. Case Rep Hematol. 2025 Oct 23;2025:8892036. doi: 10.1155/crh/8892036. eCollection 2025.

    PubMed 41180818

  • Verstovsek S, Kiladjian JJ, Vannucchi AM, Patel JL, Rambaldi A, Shomali WE, Oh ST, Usuki K, Harrison CN, Ritchie EK, Akard LP, Hernandez-Boluda JC, Huguet F, Colucci P, Zhen H, Oliveira N, Gilmartin A, Langford C, George TI, Reiter A, Gotlib J. Pemigatinib for Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement. NEJM Evid. 2025 Sep;4(9):EVIDoa2500017. doi: 10.1056/EVIDoa2500017. Epub 2025 Aug 26.

    PubMed 40856555

  • Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.

    PubMed 37934000

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemigatinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 33 sites in 11 countries.

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 7 inclusion and 4 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Germany, France, Austria, Italy and 6 more countries. 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?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Complete Response (CR) as Determined by Investigator Assessment According to the Response Criteria for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement (time frame: up to 2513 days (120 21-day treatment cycles)). 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 NCT03011372, which also lists 3 linked publications.

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 18 Nov 2025.

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