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Immunosuppressant

Itacitinib + Standard Therapy for Graft-versus-Host Disease

Phase 2

Recruiting

Led By Monzr M Al Malki

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Age =< 80 years

Karnofsky performance status >= 70%

Must not have

Uncontrolled infection (bacterial, viral, fungal)

Other active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new drug, itacitinib, can help prevent graft versus host disease (GVHD) in people who've had a stem cell transplant.

Who is the study for?

This trial is for patients up to 80 years old with certain blood cancers or disorders, like myelofibrosis and leukemia, who are eligible for a stem cell transplant. They must have good organ function and performance status, not be HIV positive or have active hepatitis B/C, agree to use birth control if applicable, and can't be pregnant or breastfeeding.

What is being tested?

The study tests adding Itacitinib to Cyclophosphamide and Tacrolimus in preventing Graft Versus Host Disease after a stem cell transplant. Itacitinib may help regulate immune cells that cause GVHD while the other drugs suppress the immune system to prevent it.

What are the potential side effects?

Possible side effects include reactions related to suppressing the immune system such as increased risk of infections, liver problems from elevated bilirubin levels, digestive issues due to cyclophosphamide, and potential complications from tacrolimus affecting kidney function.

Eligibility Criteria

Inclusion Criteria

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

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I am 80 years old or younger.

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I am able to care for myself but may not be able to do active work.

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I am eligible for a stem cell transplant from a fully matched donor.

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My lung function tests are within normal limits or my oxygen level is above 92% without assistance.

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I have HIV, HCV, or HBV, but my viral load is undetectable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any untreated infections.

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I do not have any other active cancer.

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I have had a stem cell transplant from a donor.

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I do not have any uncontrolled serious illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

GVHD-free relapse-free survival rate

Number of participants with Grade III-IV acute graft versus host disease (GVHD)

Secondary study objectives

Gut microbiome assessment

Incidence of adverse events

Incidence of cytokine release syndrome

+8 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

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: Prevention (PBSCs, cyclophosphamide, itacitinib, tacrolimus)Experimental Treatment5 Interventions

Patients undergo peripheral blood stem cell infusion on day 0. Patients receive cyclophosphamide IV QD on days 3 and 4, itacitinib PO QD on days 5-100, and tacrolimus IV or PO on days 6-65.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Tacrolimus

2019

Completed Phase 4

~5510