Jaktinib for Myelofibrosis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Must not be taking: Chemotherapy, Corticosteroids, Immunosuppressives, others

Disqualifiers: Pregnancy, Breastfeeding, Surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatments at least 14 days before starting the study drug.

What data supports the effectiveness of the drug Jaktinib for treating myelofibrosis?

Research shows that Jaktinib can effectively reduce spleen size and improve symptoms in patients with myelofibrosis, with 54.8% of patients in one study achieving significant spleen reduction. It also improved anemia and other symptoms, making it a promising option for those who cannot tolerate other treatments like ruxolitinib. ^{1 2 3 4 5}

Is Jaktinib safe for humans?

Jaktinib has been studied in healthy volunteers and patients with myelofibrosis, showing it is generally well tolerated. Common side effects include anemia (low red blood cell count), thrombocytopenia (low platelet count), neutropenia (low white blood cell count), diarrhea, dizziness, and headache, but serious side effects are rare. ^{1 2 3 6 7}

How is the drug Jaktinib different from other treatments for myelofibrosis?

Jaktinib is a novel JAK inhibitor that can be used for patients who are intolerant to ruxolitinib, another common treatment for myelofibrosis. It has shown effectiveness in reducing spleen size and improving anemia and other symptoms, with a good safety profile, making it a promising option for those who cannot tolerate existing treatments. ^{1 2 3 4 8}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

At least 18 years of age.

Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).

Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.

Exclusion Criteria

Major surgery or radiation therapy within 28 days prior to initiation of study drug.

Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.

Females who are pregnant, currently breastfeeding, planning to become pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of Jaktinib to evaluate safety and tolerability

4 weeks

Treatment

Participants receive Jaktinib for safety and efficacy evaluation

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to approximately 1 year

Treatment Details

Interventions

• Jaktinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Jaktinib Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead Sponsor

Trials

70

Recruited

8,600+

Dr. Zelin Sheng

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Executive Officer since 2009

PhD

Dr. Qingping Gao

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Chief Medical Officer since 2021

MD

Findings from Research

Ruxolitinib is a dual inhibitor of JAK1 and JAK2, which are crucial in the development of myelofibrosis (MF), and it has been FDA-approved since November 2011 for treating intermediate or high-risk MF.

The review discusses Ruxolitinib's current role in managing MF and explores its potential future applications in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Janus activated kinase inhibition in myelofibrosis. Malhotra, H.[2021]

In a phase 2 trial involving 118 patients with myelofibrosis, jaktinib demonstrated significant efficacy, with 54.8% of patients on the 100 mg BID dosage achieving a ≥35% reduction in spleen volume at week 24, compared to 31.3% in the 200 mg QD group.

Jaktinib also improved hemoglobin levels in 35.6% of patients with low baseline hemoglobin and resulted in a ≥50% improvement in total symptom scores for 69.6% of patients in the BID group, indicating its potential as a well-tolerated treatment option for myelofibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of jaktinib in the treatment of Janus kinase inhibitor-naïve patients with myelofibrosis: Results of a phase II trial. Zhang, Y., Zhou, H., Jiang, Z., et al.[2023]

In a study of 219 patients with myelofibrosis, ruxolitinib demonstrated a significant efficacy advantage over the best available therapy, with 28% of patients achieving at least a 35% reduction in spleen volume at 48 weeks, compared to 0% in the control group.

Ruxolitinib not only reduced spleen size but also improved overall quality of life and disease symptoms, with manageable side effects, primarily hematologic issues like thrombocytopenia and anemia, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. Harrison, C., Kiladjian, JJ., Al-Ali, HK., et al.[2022]

Ruxolitinib, the first approved treatment for myelofibrosis (MF), has shown significant improvements in spleen size and related symptoms in patients, based on results from Phase I/II and Phase III clinical trials involving direct comparisons to placebo and best available therapy.

While ruxolitinib is effective, it can cause side effects like cytopenias, which can be managed with dose adjustments, and there have been rare cases of infections related to immunosuppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ruxolitinib for myelofibrosis. Santos, FP., Verstovsek, S.[2021]

Ruxolitinib, the only approved JAK inhibitor for myelofibrosis (MF), has been shown to be effective in managing the disease, significantly changing treatment approaches since its introduction.

While JAK inhibitors can cause side effects like anemia, thrombocytopenia, and increased infection risk, these effects are generally predictable and manageable with careful monitoring and dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing side effects of JAK inhibitors for myelofibrosis in clinical practice. Saeed, I., McLornan, D., Harrison, CN.[2021]

Ruxolitinib is commonly used for managing myelofibrosis symptoms, but many patients experience treatment failure after 2-3 years, highlighting the need for alternative therapies like fedratinib.

Fedratinib has shown efficacy in reducing spleen volume and symptoms in patients with myelofibrosis, and ongoing trials are focused on understanding its long-term effects and managing potential gastrointestinal toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fedratinib: a pharmacotherapeutic option for JAK-inhibitor naïve and exposed patients with myelofibrosis. England, JT., Gupta, V.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Janus activated kinase inhibition in myelofibrosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of jaktinib in the treatment of Janus kinase inhibitor-naïve patients with myelofibrosis: Results of a phase II trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of ruxolitinib for myelofibrosis. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance, Pharmacokinetics of Jaktinib, a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Managing side effects of JAK inhibitors for myelofibrosis in clinical practice. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Fedratinib: a pharmacotherapeutic option for JAK-inhibitor naïve and exposed patients with myelofibrosis. [2022]