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Pregnyl® for Graft-versus-Host Disease

Phase 1 & 2
Waitlist Available
Led By Shernan Holtan, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 70 after initiation of protocol therapy
Awards & highlights

Study Summary

This trialundefined

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 70 after initiation of protocol therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 70 after initiation of protocol therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Complete Response
Number of Patients With Mixed Response
Number of Patients With No Response
+3 more
Secondary outcome measures
Number of Participants With Adverse Events as a Measure of Safety and Feasibility of hCG Supplementation With Pregnyl®
Number of Participants With Incidence of aGVHD Flare
Rate of Participants Who Fail Treatment at Day 28
+1 more

Side effects data

From 2022 Phase 1 & 2 trial • 53 Patients • NCT02525029
100%
Infections and infestations - Other,
100%
Fatigue
50%
Colitis
50%
Atrial fibrillation
50%
Edema trunk
50%
Anorexia
50%
Abdominal pain
50%
Dyspnea
50%
Anemia
50%
Cough
50%
Febrile neutropenia
50%
Ileus
50%
Vomiting
50%
Edema limbs
50%
Hypomagnesemia
50%
Hyperglycemia
50%
Lethargy
50%
Acute kidney injury
50%
Skin ulceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2
Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2
Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2
Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2
Arm 2A: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2
Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2
Arm 2B: Phase 2 Dose Level 3 2,000 USP
Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m2
Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m
Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2
Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2
Arm 1: Phase 2 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2
Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m2

Trial Design

20Treatment groups
Experimental Treatment
Group I: Arm 2B: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group II: Arm 2B: Phase 1 Dose Level 5 5,000 USP hCG/35,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group III: Arm 2B: Phase 1 Dose Level 4 3,500 USP hCG/24,500 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group IV: Arm 2B: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group V: Arm 2B: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group VI: Arm 2B: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group VII: Arm 2B: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group VIII: Arm 2B: MTDExperimental Treatment1 Intervention
After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low
Group IX: Arm 2A: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group X: Arm 2A: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XI: Arm 2A: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XII: Arm 2A: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XIII: Arm 2A: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 7 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort has reached day 21 to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XIV: Arm 2A: MTDExperimental Treatment1 Intervention
After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low
Group XV: Arm 1: Phase I Dose Level -1: 250 USP hCG/1,750 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XVI: Arm 1: Phase 2 MTDExperimental Treatment1 Intervention
After completion of the dose finding trial for each arm, the final doses will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of the activity level for Arm 1 and Arm 2. If the phase I trial enrolls fewer than 13 patients at the MTD, we will employ Simon's Minmax two-stage design with the possibility to discontinue after the 1st stage if the response rate is low
Group XVII: Arm 1: Phase 1 Dose Level 3 2,000 USP hCG/14,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XVIII: Arm 1: Phase 1 Dose Level 2 1,000 USP hCG/7,000 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XIX: Arm 1: Phase 1 Dose Level 1 500 USP hCG/3,500 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. The 1st 2 patients will be enrolled in dose level 1. The next cohort of 2 patients will not begin treatment until all patients in the current cohort have reached day 21 in order to assess for dose limiting toxicity (DLT). Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Group XX: Arm 1: Phase 1 Dose Level -2: 125 USP hCG/875 pg EGF/m^2Experimental Treatment1 Intervention
Standard of care immunosuppression, plus Pregnyl® (hCG supplementation) at assigned dose subcutaneously every other day for up to 5 doses of Pregnyl®; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic. Individual patient dose reductions: If a patient has a toxicity, the patient can drop down one dose level for the next injection and continue treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregnyl®
2001
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,572 Total Patients Enrolled
Shernan Holtan, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD
2016. "Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02525029.
~6 spots leftby Apr 2025
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