New hope for stem cell patients: safer GVHD prevention on the horizon?
NCT ID NCT04886726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether adding a drug made from urine (uhCG/EGF) to standard therapy can safely prevent graft-versus-host disease (GVHD) in stem cell transplant patients with partially matched donors. About 18 adults with blood cancers who lack a fully matched donor will receive the combination. The main goal is to find the safest dose and check for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD. 2. Age 18-70 years old 3. Performance score of at least 80% by Karnofsky 4. Adequate kidney and liver function as demonstrated by: 1. Creatinine clearance should be \>60 ml/min 2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis. 5. Negative Beta HCG test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of childbearing potential must be willing to use an effective contraceptive measure while on study. 6. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. Exclusion Criteria: 1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause 2. Active or prior CNS leukemia, unless in complete remission for at least 2 months. 3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs. 4. Uncontrolled infection 5. Donor specific antibodies 6. Ejection fraction \<40% or history of heart failure or cardiovascular disease 7. history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia. 8. Previous history hormone responsive cancer 9. history of seizure 10. history of migraine or severe headache 11. history of asthma 12. history of uterine fibroid
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henry Ford Hospital
RECRUITINGDetroit, Michigan, 48202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can adding rituximab improve remission in chronic GVHD?
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children