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PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Primary Purpose

Graft Versus Host Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
uhCG/EGF
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft Versus Host Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PTCY and uhCG/EGF

Arm Description

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

Outcomes

Primary Outcome Measures

MTD
The maximum tolerated dose
Incidence and severity of dose limiting toxicity (DLTs)
The overall incidence and severity of DLTs for uhCG/EGF

Secondary Outcome Measures

acute GVHD
Cumulative incidence of acute GVHD
Chronic GVHD
Cumulative incidence of chronic GVHD
Overall survival
Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Disease free survival
Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events

Full Information

First Posted
May 5, 2021
Last Updated
December 27, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04886726
Brief Title
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

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

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTCY and uhCG/EGF
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
uhCG/EGF
Intervention Description
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 Outcome Measure Information:
Title
MTD
Description
The maximum tolerated dose
Time Frame
day+30 post SCT
Title
Incidence and severity of dose limiting toxicity (DLTs)
Description
The overall incidence and severity of DLTs for uhCG/EGF
Time Frame
day+30 post SCT
Secondary Outcome Measure Information:
Title
acute GVHD
Description
Cumulative incidence of acute GVHD
Time Frame
till day +100 post SCT
Title
Chronic GVHD
Description
Cumulative incidence of chronic GVHD
Time Frame
one year post SCT
Title
Overall survival
Description
Death from any cause will be considered an event. Surviving patients will be censored at the time of last follow up.
Time Frame
one year post SCT
Title
Disease free survival
Description
Survival following allogeneic SCT without relapse or progression. Relapse or progression of disease, or death are considered events
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shatha farhan
Phone
3137133910
Email
sfarhan1@hfhs.org
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shatha farhan
Phone
313-713-3910
Email
sfarhan1@hfhs.org

12. IPD Sharing Statement

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PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

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