A Study of JNJ-88549968 for CALR-Mutated Myeloproliferative Neoplasms
This study is testing a new drug called JNJ-88549968 for people with certain blood cancers called essential thrombocythemia (ET) or myelofibrosis (MF). These cancers must have a specific genetic change called a calreticulin (CALR) mutation. The main goals are to find a safe dose of JNJ-88549968 and to understand its side effects. For participants in the US with MF, JNJ-88549968 may also be given with ruxolitinib or momelotinib. The study is looking for 241 participants aged 18 or older who have these specific CALR-mutated conditions.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 241 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for up to 2 years after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
At a glance
Conditions
Where it's being run
39 sites across 21 statesStudy leadership
- Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)Approximately up to 35 days after first dose of study treatment
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident.
- Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)Up to 2 years
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
- Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by SeverityUp to 2 years
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events \[ICANS\]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.