What side effects are associated with this type of intervention?

Common treatments for Myelofibrosis include JAK1/2 inhibitors like Ruxolitinib and CDK4/6 inhibitors like Abemaciclib. Ruxolitinib is known to cause side effects such as anemia, thrombocytopenia, and increased risk of infections. Discontinuation can lead to a withdrawal syndrome characterized by fever, hypotension, and hypoxia. Abemaciclib, a CDK4/6 inhibitor, can cause gastrointestinal issues like diarrhea, as well as neutropenia and fatigue. Both treatments require careful monitoring to manage these adverse effects effectively.

What prior FDA approvals exist?

Ruxolitinib, a JAK1/2 inhibitor, has been FDA-approved for the treatment of Myelofibrosis and has shown efficacy in reducing spleen size and alleviating symptoms. Another JAK inhibitor, Fedratinib, has also been approved and demonstrated effectiveness in reducing splenomegaly and symptom burden. These treatments focus on targeting the JAK-STAT pathway, which is crucial in the pathophysiology of Myelofibrosis. There is no mention of FDA-approved CDK4/6 inhibitors like Abemaciclib specifically for Myelofibrosis in the provided context.

What other types of research exist?

Promising novel alternatives to Ruxolitinib and Abemaciclib for Myelofibrosis patients in 2024 include: 1) Fedratinib, a JAK2 inhibitor that has shown efficacy in patients resistant to Ruxolitinib. 2) Pacritinib, another JAK2 inhibitor, particularly beneficial for patients with low platelet counts. 3) Navitoclax, a BCL-2/BCL-xL inhibitor, which is being studied in combination with Ruxolitinib for enhanced efficacy. These alternatives offer different mechanisms of action and may provide options for patients who do not respond to or cannot tolerate Ruxolitinib and Abemaciclib.

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Kinase Inhibitor

Ruxolitinib + Abemaciclib for Myelofibrosis

Phase 1

Recruiting

Led By Raajit Rampal

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests a new drug combo to treat a blood disorder. It will check if it's safe & effective.

Who is the study for?

This trial is for adults with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis who haven't responded well to ruxolitinib alone. They should have a life expectancy of at least 24 weeks, be able to swallow pills, and not be pregnant or breastfeeding. Participants must use effective contraception and cannot have used CDK4/6 inhibitors before.Check my eligibility

What is being tested?

The study tests if combining ruxolitinib with abemaciclib safely and effectively treats myelofibrosis. Patients previously treated with ruxolitinib but still having symptoms or an enlarged spleen will receive both drugs to see if their condition improves.See study design

What are the potential side effects?

Possible side effects include risks from the individual drugs: Ruxolitinib may cause dizziness, headache, low blood counts; Abemaciclib can lead to diarrhea, fatigue, nausea. Both could potentially affect liver function and increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with dose-limiting toxicity (DLT)

Secondary outcome measures

overall response rate (ORR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ruxolitinib plus AbemaciclibExperimental Treatment2 Interventions

This will be a phase 1 study with a traditional "3+3" design of combination ruxolitinib (at fixed doses of 10mg BID or 15mg BID) and abemaciclib. There are 3 planned dose levels of abemaciclib: 50, 100 and 150 mg. Cycles will be 4 weeks (28 days) long and DLT window will consist of first cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Abemaciclib

2019

Completed Phase 2

~1710

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ruxolitinib, a JAK1/2 inhibitor, works by blocking the Janus kinase (JAK) pathway, which is often overactive in Myelofibrosis. This inhibition reduces the abnormal signaling that leads to excessive blood cell production and fibrosis in the bone marrow, thereby alleviating symptoms and reducing spleen size. Abemaciclib, a CDK4/6 inhibitor, targets cyclin-dependent kinases 4 and 6, which are crucial for cell cycle progression. By inhibiting these kinases, Abemaciclib can slow down the proliferation of malignant cells. For Myelofibrosis patients, these treatments are significant as they address the underlying pathophysiology of the disease, potentially improving quality of life and disease outcomes.

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Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,941 Previous Clinical Trials

588,898 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,624 Previous Clinical Trials

3,216,911 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

368 Previous Clinical Trials

55,443 Total Patients Enrolled

Media Library

Abemaciclib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05714072 — Phase 1

Myelofibrosis Research Study Groups: Ruxolitinib plus Abemaciclib

Myelofibrosis Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05714072 — Phase 1

Abemaciclib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714072 — Phase 1

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