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New treatment option for Neoplasms
Official title A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT06150157
What this study is testing
What is JNJ-88549968?
JNJ-88549968 is an investigational medicine, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D(s)) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the...
- Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
- Participants with ET and MF with risk characteristics as described in the protocol
- Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2
- For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor
You likely can't join if
- Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
- Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell...
- Prior solid organ transplantation
- Either of the following regarding hematopoietic stem cell transplantation:
- Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or
- Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
See the full eligibility criteria
- Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent
- Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
- Participants with ET and MF with risk characteristics as described in the protocol
- Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2
- For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor
- Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
- Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy...
- Prior solid organ transplantation
- Either of the following regarding hematopoietic stem cell transplantation:
- Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or
- Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
- History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Aurora, Colorado, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Tianjin, China
- Paris, France
- Pierre-Bénite, France
- Toulouse, France
- Aachen, Germany
- Berlin, Germany
- Essen, Germany
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Aurora, Colorado, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Ann Arbor, Michigan, United States; New York, New York, United States and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.