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Graft Versus Host Disease Prophylaxis

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

Q: What objectives is this research endeavor seeking to fulfill?

This clinical trial aims to measure the maximum tolerated dose of a drug 30 days after stem cell transplantation. Secondary objectives are measuring cumulative incidence of acute and chronic graft-versus-host disease, as well as gauging survival without relapse or progression in terms of diseases and death.

Q: For whom is this research opportunity available?

This investigation aims to recruit 18 participants aged between eighteen and seventy. The main requirements for enrolment are as follows: age range of 18-70, Karnofsky performance score of no less than 80%, hematological malignancy in need of allogeneic stem cell transplantation with minimal residual disease or mismatched unrelated donor.

Q: Are there still slots available for individuals to join this medical experiment?

Affirmative. According to clinicaltrials.gov, this trial is currently recruiting for 18 participants from a single location. The study was initially posted on December 23rd 2021 and last updated the same day.

Q: What is the ceiling for participants in this clinical trial?

Affirmative. According to the information posted on clinicaltrials.gov, this research is actively enrolling participants. It was initially listed on December 23rd 2021 and has been updated recently on the same day. The study requires 18 volunteers from a single clinic location.

Q: What evidence has been found regarding the security of uhCG/EGF for patients?

We assign a score of 1 to uhCG/EGF's safety, as this is an early phase trial and there is little-to-no clinical data that supports its efficacy or security.

Q: Is the age limit for this trial inclusive of those under two decades old?

The eligibility requirements for this investigation dictate that only individuals who are over 18 and below 70 years of age may participate.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post sct

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

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

Primary outcome measures

Incidence and severity of dose limiting toxicity (DLTs)

MTD

Secondary outcome measures

Chronic GVHD

Disease free survival

Overall survival

+1 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,864 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

Frequently Asked Questions

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

What objectives is this research endeavor seeking to fulfill?

"This clinical trial aims to measure the maximum tolerated dose of a drug 30 days after stem cell transplantation. Secondary objectives are measuring cumulative incidence of acute and chronic graft-versus-host disease, as well as gauging survival without relapse or progression in terms of diseases and death."

Answered by AI

For whom is this research opportunity available?

"This investigation aims to recruit 18 participants aged between eighteen and seventy. The main requirements for enrolment are as follows: age range of 18-70, Karnofsky performance score of no less than 80%, hematological malignancy in need of allogeneic stem cell transplantation with minimal residual disease or mismatched unrelated donor."

Answered by AI

Are there still slots available for individuals to join this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting for 18 participants from a single location. The study was initially posted on December 23rd 2021 and last updated the same day."

Answered by AI

What is the ceiling for participants in this clinical trial?

"Affirmative. According to the information posted on clinicaltrials.gov, this research is actively enrolling participants. It was initially listed on December 23rd 2021 and has been updated recently on the same day. The study requires 18 volunteers from a single clinic location."

Answered by AI

What evidence has been found regarding the security of uhCG/EGF for patients?

"We assign a score of 1 to uhCG/EGF's safety, as this is an early phase trial and there is little-to-no clinical data that supports its efficacy or security."

Answered by AI