RECRUITING

Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

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Conditions

Acute-graft-versus-host DiseaseaGVHD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD. This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib. After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.

Official Title

Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study

Quick Facts

Study Start:2023-06-05
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05123040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly diagnosed Minnesota high-risk aGVHD -OR-
  2. * Newly diagnosed Minnesota standard risk aGVHD with plasma amphiregulin ≥ 33 pg/ml tested at the UMN Cytokine Reference Lab. For amphiregulin lab ordering information, see Fairview Lab Guide: http://labguide.fairview.org/showtest.asp?testid=6766\&format=long -OR-
  3. * Newly diagnosed Minnesota standard risk aGVHD Ann Arbor 3 biomarkers tested by Viracor. For ordering information, see: https://www.viracor-eurofins.com/test-menu/403572p-agvhd-symptomatic- onset-algorithm/
  4. * Renal: Serum creatinine ≤2.5x upper limit of normal (ULN)
  5. * Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%
  6. * Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds).
  1. * Progressive malignancy
  2. * Uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment
  3. * Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations)
  4. * Unwilling or unable to stop GnRH antagonists, aromatase inhibitors, or anti-androgens
  5. * History of a hormone responsive malignancy
  6. * Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible
  7. * Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
  8. * Pregnancy
  9. * Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment

Contacts and Locations

Study Contact

Cancer Center Clinical Trials Office
CONTACT
612 624 2620
ccinfo@umn.edu

Principal Investigator

Sherman Holtan, MD
PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota

Study Locations (Sites)

Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

  • Sherman Holtan, MD, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-05
Study Completion Date2028-09

Study Record Updates

Study Start Date2023-06-05
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • aGVHD

Additional Relevant MeSH Terms

  • Acute-graft-versus-host Disease