PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Launched by HENRY FORD HEALTH SYSTEM · May 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to prevent Graft Versus Host Disease (GVHD) in patients undergoing stem cell transplants. GVHD is a condition where the transplanted cells attack the patient’s body. The researchers want to see if combining two treatments, post-transplant cyclophosphamide and a special protein mixture (uhCG/EGF), can help reduce the risk of GVHD. This is the first phase of the study, focusing on whether this combination is safe and feasible. They will also look at how many patients develop GVHD and how it affects their overall health and survival.

To participate in this trial, patients must be between 18 and 70 years old and have certain blood cancers that require a specific type of stem cell transplant. They should have good overall health, with normal kidney and liver function, and women must take precautions against pregnancy. Participants can expect close monitoring during the trial to ensure their safety. It's important to note that certain health conditions, like active infections or heart problems, may prevent someone from joining the study. This trial is currently recruiting participants, so if you or someone you know is interested, it may be worth discussing with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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