Momelotinib During and After HCT in Myelofibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This is a single-center, open-label, phase I study to determine the safety and tolerability of momelotinib in patients with myelofibrosis during and after hematopoietic cell transplantation (HCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have pathologically confirmed primary myelofibrosis (PMF) according to WHO criteria or secondary myelofibrosis as defined by the IWG-MRT criteria.
Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) Plus criteria OR
Intermediate-1 risk disease with at least one of the following unfavorable features known to impact the survival adversely
Red cell transfusion dependency
Disqualifiers
Known intolerance or hypersensitivity to any JAK inhibitor, including ruxolitinib, fedratinib, pacritinib, momelotinib or any other JAK inhibitor, its metabolites or formulation excipients.
Has had any major surgery within 28 days prior to randomization
Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention
Has received immunosuppressive agents within 28 days
Trial design
Design model
Single group
Treatments tested in this trial
Momelotinib
DrugAdministered orally once per day during each 28-day cycle. This will start on day -7 (7 days before HCT) and continue for up to 13 cycles. Dose cohorts (100 mg daily, 150 mg daily, 200 mg daily) will be investigated in the peri-transplant period. Once participants have achieved hematopoietic recovery and are at least Day 21 after HCT, participants will increase the dose to 200 mg daily.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Momelotinib + Standard of Care (SOC) Hematopoietic Cell Transplantation (HCT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (MTD) of Momelotinib
MTD is defined as the highest dose level at which 0 or 1 of 6 patients experience a Dose Limiting Toxicity (DLT). Toxicities will be graded and documented according to NCI CTCAE version 5.0.
Time frame
From start of study treatment (Day -7) through 28 days.Secondary outcomes
1
Incidence of momelotinib-related toxicities
Toxicity will be categorized and graded per NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
Time frame
Day -7 through 30 days after end of treatment (up to 394 days)2
Median Duration of Momelotinib Therapy
Median duration of momelotinib therapy during and after allogeneic HCT will be calculated and is the duration of study treatment which divides the shortest 50% and longest 50% of treatment durations.
Time frame
Day -7 through end of treatment, up to 364 days.3
Median time to neutrophil engraftment
Neutrophil engraftment will be defined as first of 3 successive days with an absolute neutrophil count of greater than or equal to 0.5 x 10\^9/l after post-HCT nadir. Median time to neutrophil engraftment for participants receiving momelotinib during allogeneic HCT will be calculated.
Time frame
Day 0 (Day of HCT) through Day 60.4
Median time to platelet engraftment
Platelet engraftment will be defined as first of 3 successive days with platelet count of greater than or equal to 20 x 10\^9/l in the absence of platelet transfusion for 7 consecutive days. Median time to platelet engraftment for participants receiving momelotinib during allogeneic HCT will be calculated.
Time frame
Day 0 (Day of HCT) through Day 60.Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov