PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04886726
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease	Drug: uhCG/EGF	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: Dec 23, 2021
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTCY and uhCG/EGF 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	Drug: uhCG/EGF; 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

Outcome Measures

Primary Outcome Measures

1. MTD [day+30 post SCT]

   The maximum tolerated dose

2. Incidence and severity of dose limiting toxicity (DLTs) [day+30 post SCT]

   The overall incidence and severity of DLTs for uhCG/EGF

Secondary Outcome Measures

1. acute GVHD [till day +100 post SCT]

   Cumulative incidence of acute GVHD

2. Chronic GVHD [one year post SCT]

   Cumulative incidence of chronic GVHD

3. Overall survival [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 [one year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. Creatinine clearance should be >60 ml/min

6. Total Bilirubin <1.5, ALT/AST/Alk Phos < 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.

7. 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.

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shatha Farhan, Clinical Assistant Professor, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT04886726
• Other Study ID Numbers: 14916
• First Posted: May 14, 2021
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Jan 12, 2022