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Recruiting

NCT Number: NCT04886726

PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

shatha farhan

CONTACT

[email protected]

313-713-3910

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
  • Age 18-70 years old
  • Performance score of at least 80% by Karnofsky
  • Adequate kidney and liver function as demonstrated by:
  • Creatinine clearance should be >60 ml/min
  • Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
  • 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.
  • Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.

Exclusion criteria

  • Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
  • Active or prior CNS leukemia, unless in complete remission for at least 2 months.
  • History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
  • Uncontrolled infection
  • Donor specific antibodies
  • Ejection fraction <40% or history of heart failure or cardiovascular disease
  • history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
  • Previous history hormone responsive cancer
  • history of seizure
  • history of migraine or severe headache
  • history of asthma
  • history of uterine fibroid

Treatment and study plan

uhCG/EGF

Drug

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

Primary outcomes

  1. MTD

    Time frame: day+30 post SCT

    The maximum tolerated dose

  2. Incidence and severity of dose limiting toxicity (DLTs)

    Time frame: day+30 post SCT

    The overall incidence and severity of DLTs for uhCG/EGF

Secondary outcomes

  1. acute GVHD

    Time frame: till day +100 post SCT

    Cumulative incidence of acute GVHD

  2. Chronic GVHD

    Time frame: one year post SCT

    Cumulative incidence of chronic GVHD

  3. Overall survival

    Time frame: one year post SCT

    Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.

  4. Disease free survival

    Time frame: one year

    Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events

Study contacts

Contact information is provided by the study sponsor or research team.

shatha farhan

CONTACT

[email protected]

3137133910

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Post-transplant Cyclophosphamide and Urinary-derived Human Chorionic Gonadotropin and Epidermal Growth Factor (uhCG/EGF) as Graft Versus Host Disease Prophylaxis for Mismatched Unrelated Donor Transplantation

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 14, 2021
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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