Clinical trial · Interventional
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
NCT04629508CI-TRIAL-00094334completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
| Thrombocythemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 : Dose Escalation of itacitinib
- description
- Participants will be dosed at different dose levels with a maximum of up to 9 participants per dose level.
- interventionNames
- Drug: itacitinib
- type
- EXPERIMENTAL
- label
- Part 2 : Dose Expansion of itacitinib
- description
- Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1.
- interventionNames
- Drug: itacitinib
Primary outcomes (3)
- measure
- Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria. * At least Intermediate 1 risk MF according to the DIPSS. * Prior treatment with ruxolitinib and/or fedratinib monotherapy * Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF. * Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening. * Allogeneic stem cell transplant not planned. * Platelet is greater than or equal to 50 × 109/L at screening. * Ability to comprehend and willingness to sign a written ICF for the study. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib * Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening * For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents * Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1 * Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib * Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement * Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study * ECOG performance status ≥ 3 * Life expectancy less than 24 weeks * Not willing to receive RBC or platelet transfusions * Participants with laboratory values at screening outside of protocol defined ranges * Significant concurrent, uncontrolled medical condition * Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor * History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment. * Evidence of HBV or HCV infection or risk of reactivation * Known HIV infection.
References
Publications (0)
Data not yet available
No reference posted for this study.