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Janus Kinase Inhibitor

Itacitinib for Graft-versus-Host Disease Prevention

Phase 1

Waitlist Available

Led By Ramzi Abboud, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

- Acute myelogenous leukemia (AML) in complete morphological remission (based on International Working Group (IWG) Criteria)

Diagnosis of a hematological malignancy listed below:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 180

Awards & highlights

Study Summary

This trial is testing whether a drug that inhibits Janus kinase 1 (JAK1) can help reduce graft-versus-host-disease (GVHD) and cytokine release syndrome (CRS) while still retaining the benefits of graft-versus-leukemia (GVL) and improving engraftment.

Who is the study for?

Adults with certain blood cancers (like AML, ALL, MDS, NHL or Hodgkin's) in remission can join this trial. They need a related donor without hepatitis or HIV who is HLA-haploidentical. Participants must be healthy enough for stem cell transplant and not have had prior allogeneic transplants (autologous is okay), no recent investigational drugs, no severe illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial tests Itacitinib to prevent serious complications after a specific type of stem cell transplant from half-matched donors. The focus is on safety regarding how well patients accept the new cells and if they avoid severe graft-versus-host disease.See study design

What are the potential side effects?

Itacitinib might cause liver issues, infections due to weakened immune system responses, potential changes in blood counts leading to anemia or bleeding risks, and possibly respiratory problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML is currently in complete remission.

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I have been diagnosed with a blood cancer.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am 18 years old or older.

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My ALL is in complete remission and shows no minimal residual disease.

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My donor is a half-match for me according to the hospital's tests.

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My bone marrow has less than or equal to 5% cancer cells.

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My lymphoma is in its 2nd or later remission.

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I am scheduled for a specific bone marrow transplant using a family member's cells.

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I can take specific medications to prevent organ rejection after a transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cumulative incidence of grades III-IV acute GVHD

Cumulative incidence of graft failure (pilot study only)

Secondary outcome measures

Cumulative incidence of grades II-IV acute GVHD (expansion phase)

Number of participants who experience cytokine release syndrome (CRS)

Treatment related mortality

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pilot Study: ItacitinibExperimental Treatment4 Interventions

Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.

Group II: Expansion Phase: ItacitinibExperimental Treatment4 Interventions

Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy Stem cell transplantation on Day 0 Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stem cell transplantation

2007

Completed Phase 2

~330

Itacitinib

2020

Completed Phase 3

~910

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,110 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,654 Total Patients Enrolled

American Society of HematologyOTHER

11 Previous Clinical Trials

20,803 Total Patients Enrolled

Media Library

Itacitinib (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03755414 — Phase 1

Acute Myeloid Leukemia Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT03755414 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there prior investigations that used Itacitinib as a research tool?

"Currently, 23 clinical studies on Itacitinib are being conducted with one of them in Phase 3. The many research initiatives pertaining to this treatment predominantly take place in Philadelphia but there are 397 trial sites available overall."

Answered by AI

Are there any open enrolment opportunities for this trial?

"Per records on clinicaltrials.gov, this experiment is recruiting participants as of now. It was first publicised on September 4th 2019 and the most recent update happened on August 23rd 2022."

Answered by AI

Is this trial pioneering within its field?

"Clinical research into Itacitinib began in 2013 and Incyte Corporation sponsored the first trial which included 121 participants. This was followed by Phase 1 drug approval. Today, there are 23 active trials involving centres located in 76 cities across 20 countries worldwide."

Answered by AI

How many participants are currently enrolled in this research project?

"Affirmative. Clinicaltrials.gov has the latest information that this medical trial is in search of subjects - it was first posted on September 4th 2019 and most recently revised on August 23rd 2022. The research program requires 55 individuals to be recruited from 1 location."

Answered by AI

Has the FDA sanctioned Itacitinib for therapeutic use?

"Due to the preliminary nature of this trial, our team determined that Itacitinib's safety should be rated a 1 on a scale from 1-3. This reflects the limited amount of data currently available indicating its efficacy and risk profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

2019. "Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03755414.

All > Graft Vs Host Disease > Myelodysplastic Syndrome