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Graft Versus Host Disease Prophylaxis

PTCY + uhCG/EGF for Graft-versus-Host Disease Prophylaxis

Phase 1
Recruiting
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis
Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD
Must not have
Ejection fraction <40% or history of heart failure or cardiovascular disease
History of uterine fibroid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to prevent GVHD in stem cell transplants for people with MMUDs. The goal is to see if it's safe and effective.

Who is the study for?
This trial is for adults aged 18-70 with certain blood cancers needing a stem cell transplant but without matched donors. They must be mostly healthy, with good organ function and performance status. Women of childbearing age need a negative pregnancy test and must use birth control during the study.
What is being tested?
The study tests combining post-transplant cyclophosphamide (PTCY) with uhCG/EGF to prevent graft versus host disease after stem cell transplants from mismatched unrelated donors (MMUDs). It aims to assess safety, feasibility, and effects on disease progression and survival rates.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased infection risk, liver or kidney issues due to medication toxicity, hormonal changes because of uhCG/EGF, and general side effects like nausea or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver function tests are within normal limits and I don't have chronic hepatitis or cirrhosis.
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I have a blood cancer and am eligible for a stem cell transplant without a full match.
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I can carry out normal activities with minimal symptoms.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's pumping ability is weak, or I have a history of heart failure or heart disease.
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I have had uterine fibroids in the past.
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I have had seizures in the past.
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I do not have any infections that are not responding to treatment.
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I have donor-specific antibodies.
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I do not have HIV, hepatitis, or cirrhosis.
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I have had cancer that responded to hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post sct
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post sct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of dose limiting toxicity (DLTs)
MTD
Secondary study objectives
Chronic GVHD
Disease free survival
Overall survival
+1 more

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: PTCY and uhCG/EGFExperimental Treatment1 Intervention
PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,375 Total Patients Enrolled

Media Library

uhCG/EGF (Graft Versus Host Disease Prophylaxis) Clinical Trial Eligibility Overview. Trial Name: NCT04886726 — Phase 1
Graft-versus-Host Disease Research Study Groups: PTCY and uhCG/EGF
Graft-versus-Host Disease Clinical Trial 2023: uhCG/EGF Highlights & Side Effects. Trial Name: NCT04886726 — Phase 1
uhCG/EGF (Graft Versus Host Disease Prophylaxis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886726 — Phase 1
~7 spots leftby Nov 2026
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