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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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
55,406 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,438 Total Patients Enrolled
American Society of HematologyOTHER
12 Previous Clinical Trials
20,935 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving antithymocyte globulin before my transplant.I have not had a transplant from another person.My AML is currently in complete remission.My donor couldn't give enough cells but my doctor decides to proceed with the transplant.I have been diagnosed with a blood cancer.I am 18 years old or older.I am not on high doses of steroids, except for adrenal insufficiency.I can take care of myself and am up and about more than half of my waking hours.My kidney function, measured by creatinine levels or clearance, is within the required range.I do not have any severe illnesses that could interfere with the study.I do not have myelofibrosis or any condition that delays my recovery after a transplant.I have myelofibrosis and am interested in the expansion phase.I am 18 years old or older.My ALL is in complete remission and shows no minimal residual disease.My donor is a half-match for me according to the hospital's tests.My bone marrow has less than or equal to 5% cancer cells.I have a donor who matches half of my HLA markers.You are allergic to the study drugs Ruxolitinib or Itacitinib.I do not have HIV or active hepatitis B or C.I have a blood relative who could be a donor, with younger ones preferred.I can understand and am willing to sign a consent form.My organs are functioning well.My lymphoma is in its 2nd or later remission.I am scheduled for a specific bone marrow transplant using a family member's cells.I have high levels of specific antibodies against a donor organ.I can take specific medications to prevent organ rejection after a transplant.My lung function tests show at least 40% of the predicted capacity.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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