What side effects are associated with this type of intervention?

Common treatments for Myelofibrosis, particularly Janus kinase (JAK) inhibitors like ruxolitinib and fedratinib, are associated with several side effects. These include grade ≥3 anemia and thrombocytopenia, reported in 38% and 22% of patients, respectively. Other potential side effects may include gastrointestinal symptoms, infections, and elevated liver enzymes. It is important for patients to discuss these risks with their healthcare provider to manage and mitigate side effects effectively.

What prior FDA approvals exist?

The FDA has approved several Janus kinase (JAK) inhibitors for the treatment of Myelofibrosis. Ruxolitinib, marketed under the brand name Jakafi, was the first JAK inhibitor approved for this condition. It has been shown to relieve symptoms and reduce spleen size in patients with Myelofibrosis. Another JAK inhibitor, Fedratinib, sold under the brand name Inrebic, has also been approved for the treatment of intermediate-2 or high-risk primary or secondary Myelofibrosis. These drugs work by inhibiting the JAK-STAT pathway, which is often dysregulated in Myelofibrosis.

What other types of research exist?

Promising novel alternatives to Jaktinib for Myelofibrosis patients include ruxolitinib and fedratinib, both of which are Janus kinase inhibitors. Additionally, emerging therapies such as pegylated interferon alpha-2b and combination treatments involving azacitidine are being explored for their efficacy in treating myeloproliferative disorders.

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Tyrosine Kinase Inhibitor

Jaktinib for Myelofibrosis

Phase 1

Recruiting

Research Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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 at least 24 weeks, up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Jaktinib, a drug for treating Myelofibrosis in patients who haven't responded to other treatments. The drug aims to block signals that help cancer cells grow. Jaktinib is currently being studied for its potential to treat myelofibrosis.

Who is the study for?

This trial is for adults over 18 with myelofibrosis who haven't responded well to standard treatments. They should be relatively stable (ECOG PS 0, 1, or 2) and expected to live more than 24 weeks. Pregnant or breastfeeding women can't join, nor those planning pregnancy without effective contraception.

What is being tested?

The study is testing Jaktinib Hydrochloride Tablets as a new treatment option for Myelofibrosis. It's aimed at patients who have not had success with existing FDA-approved JAK inhibitors.

What are the potential side effects?

While the specific side effects of Jaktinib are not listed here, similar drugs often cause issues like dizziness, headaches, nausea, low blood counts leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least 24 weeks, up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least 24 weeks, up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 24 weeks, up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets

Safety of jaktinib hydrochloride tablets

Secondary study objectives

Efficacy of jaktinib hydrochloride tablets

Tablet Dosage Form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: JaktinibExperimental Treatment1 Intervention

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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

Janus kinase (JAK) inhibitors, such as ruxolitinib and the investigational drug Jaktinib, work by blocking the JAK-STAT signaling pathway, which is often overactive in Myelofibrosis. This pathway is crucial for the regulation of blood cell production and immune function. By inhibiting this pathway, JAK inhibitors can reduce the abnormal proliferation of blood cells and alleviate symptoms such as splenomegaly (enlarged spleen) and constitutional symptoms (e.g., fatigue, night sweats). This is particularly important for Myelofibrosis patients as it helps manage disease symptoms, improve quality of life, and potentially slow disease progression.