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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
GVHD-free relapse-free survival rate
Number of participants with Grade III-IV acute graft versus host disease (GVHD)
Secondary outcome measures
Gut microbiome assessment
Incidence of adverse events
Incidence of cytokine release syndrome
+8 moreSide effects data
From 2014 Phase 3 trial • 87 Patients • NCT0007547823%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
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
Tacrolimus
2011
Completed Phase 4
~4740
Itacitinib
2020
Completed Phase 3
~910
Cyclophosphamide
1995
Completed Phase 3
~3770
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,610 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,804 Total Patients Enrolled
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
284 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any untreated infections.I am 80 years old or younger.I am over 70, can do most activities myself, and have few other health issues.I am able to care for myself but may not be able to do active work.I am eligible for a stem cell transplant from a fully matched donor.My lung function tests are within normal limits or my oxygen level is above 92% without assistance.I do not have any other active cancer.I may not have tissue samples available, but can get approval from the study leader.I have had a stem cell transplant from a donor.I do not have any uncontrolled serious illnesses.I have HIV, HCV, or HBV, but my viral load is undetectable.I haven't had chemotherapy, radiation, or immunotherapy in the last 21 days.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (PBSCs, cyclophosphamide, itacitinib, tacrolimus)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the process of enlisting participants currently in progress for this trial?
"According to the clinicaltrials.gov database, this specific medical study is no longer seeking participants; it was first posted on November 20th 2022 and last updated on September 26th 2022. Nevertheless, there are 1933 other trials recruiting patients at present."
Answered by AI
How does the potential risk of Peripheral Blood Stem Cell Transplantation compare to its benefit for patients?
"After careful analysis, the team at Power has rated Peripheral Blood Stem Cell Transplantation a 2 out of 3 on safety due to its status as an experimental Phase 2 trial. While there is some data indicating it may be safe, no efficacy results have been documented yet."
Answered by AI
What are the ultimate aims of this medical experiment?
"This clinical trial aims to reduce Grade III-IV acute GVHD by day 100, with secondary objectives of monitoring non-relapse mortality, rate of infection and progression free survival. To further detail the latter two goals, microbiologically documented infections will be reported according to date and severity while progress free survival will be tracked using the Kaplan-Meier method between -7 days and 120 post transplant."
Answered by AI
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