Continued Itacitinib Treatment for Myelofibrosis

Recruiting at 25 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must be taking: Itacitinib

Disqualifiers: Uncontrolled illness, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: As long as tolerated and beneficial

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial provides the medication itacitinib to participants from previous studies who may benefit from continued treatment. Itacitinib helps reduce inflammation by blocking specific proteins that cause it.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since this study is a continuation of previous itacitinib treatment, it is likely that you can continue your current regimen if it was part of the original study.

What data supports the effectiveness of the drug itacitinib for myelofibrosis?

Itacitinib is a JAK1 inhibitor, similar to ruxolitinib, which is a JAK1/2 inhibitor that has shown effectiveness in treating myelofibrosis by reducing symptoms like enlarged spleen and improving quality of life. While specific data on itacitinib for myelofibrosis is not provided, the success of similar JAK inhibitors suggests potential benefits. ^{1 2 3 4 5}

How does the drug itacitinib differ from other treatments for myelofibrosis?

Itacitinib is a JAK1 inhibitor, which may offer a different approach compared to existing JAK2 inhibitors like ruxolitinib, the current standard treatment for myelofibrosis. This difference in targeting could potentially lead to varied effects on symptoms and side effects, providing an alternative for patients who may not respond well to JAK2 inhibitors. ^{2 3 6 7 8}

Research Team

Lance Leopold, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for patients already taking itacitinib in other Incyte-sponsored studies, who are benefiting and tolerating the treatment well. They must understand and agree to study procedures, avoid pregnancy or fathering children, and not have any illness that could risk their safety or study compliance.

Inclusion Criteria

Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements

Willingness to avoid pregnancy or fathering children

Ability to comprehend and willingness to sign an ICF

Exclusion Criteria

Pregnant or breastfeeding women

Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol

I can get itacitinib through a pharmacy or my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive continued treatment with itacitinib as per the treatment dose and schedule from their original study

As long as tolerated and beneficial

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• itacitinib

Trial Overview The trial provides ongoing access to itacitinib for participants from previous related studies. It's an open-label study where all involved know they're receiving itacitinib at doses and schedules set by earlier trials as long as benefits continue and side effects remain manageable.

Participant Groups

Group I: itacitinib Experimental Treatment 1 Intervention

Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Findings from Research

Selective JAK2 inhibitors have shown significant efficacy in reducing symptoms and splenomegaly in myelofibrosis patients, providing benefits that previous treatments could not achieve, although they may cause anemia and gastrointestinal issues.

The development of enhanced prognostic models is improving the ability to assess individual patient outcomes in myelofibrosis, which is crucial for balancing the benefits of new therapies against the risks of more invasive treatments like stem cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing new therapies and their overall impact in myelofibrosis. Mesa, RA.[2016]

Ruxolitinib, an oral JAK1 and JAK2 inhibitor, has transformed the treatment of myelofibrosis (MF) since its approval, demonstrating significant clinical benefits in patients as shown in the phase 3 COMFORT-I/II trials.

Over the past 10 years, extensive research on ruxolitinib has enhanced the understanding of MF and its management, paving the way for future combination therapies to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten years after ruxolitinib approval for myelofibrosis: a review of clinical efficacy. Pemmaraju, N., Bose, P., Rampal, R., et al.[2023]

In a study of 703 myelofibrosis patients, 31.2% discontinued ruxolitinib, and 27.4% of those were successfully rechallenged, showing significant improvements in spleen size and symptoms during the treatment.

Patients who were rechallenged with ruxolitinib had a median overall survival of 27.9 months, which was significantly longer compared to those who permanently discontinued the drug, indicating a potential survival benefit from rechallenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruxolitinib rechallenge in resistant or intolerant patients with myelofibrosis: Frequency, therapeutic effects, and impact on outcome. Palandri, F., Tiribelli, M., Breccia, M., et al.[2022]

Myelofibrosis (MF) is a serious blood cancer with varying prognoses; patients with low-risk disease can survive 6-15 years, while those with high-risk disease or transformed acute myeloid leukemia (AML) have a much poorer prognosis, often less than 3 months.

The only curative treatment for MF is allogeneic stem cell transplantation, but since most patients are ineligible, they typically receive older drugs for symptom relief. However, new JAK1/JAK2 inhibitors like ruxolitinib show promise based on positive results from large phase III studies, indicating a potential shift in treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and laboratory features of myelofibrosis and limitations of current therapies. Gregory, SA., Mesa, RA., Hoffman, R., et al.[2022]

References

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

Setting Appropriate Goals for the Next Generation of Clinical Trials in Myelofibrosis. [2021]

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

Assessing new therapies and their overall impact in myelofibrosis. [2016]

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

Ten years after ruxolitinib approval for myelofibrosis: a review of clinical efficacy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Novel treatments to tackle myelofibrosis. [2023]

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

Ruxolitinib rechallenge in resistant or intolerant patients with myelofibrosis: Frequency, therapeutic effects, and impact on outcome. [2022]

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

Clinical and laboratory features of myelofibrosis and limitations of current therapies. [2022]

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

Ruxolitinib: long-term management of patients with myelofibrosis and future directions in the treatment of myeloproliferative neoplasms. [2021]

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

The evolving treatment paradigm in myelofibrosis. [2021]