A Study to Evaluate Steroid-free Treatment for Standard-Risk aGVHD (BMT CTN 1501)

Description

The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.

Study Start Date

October, 01 2016

Estimated Completion Date

October 2020

Interventions

  • Drug: Prednisone
  • Drug: Sirolimus

Study ID

Medical College of Wisconsin -- BMTCTN1501

Status

Recruiting

Trial ID

NCT02806947

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

150

Sponsor

Medical College of Wisconsin

Inclusion Criteria

    1. Patients with standard-risk acute GVHD, according to refined Minnesota Criteria. Refined Minnesota Criteria are available at https://redcap.ahc.umn.edu/surveys/?s=bNmFhseJIf. Standard-risk acute GVHD according to the refined Minnesota Risk Criteria requires meeting one of the criteria below: 1. Single organ involvement (Stage 1-3 skin, Stage 1 upper GI, or Stage 1-2 lower GI) 2. Multiple organ involvement (Stage 1-3 skin plus stage 1 upper GI, Stage 1-3 skin plus stage 1 lower GI, Stage 1-3 skin plus stage 1 lower GI plus stage 1 upper GI, Stage 1-3 skin plus stage 1-4 liver, or Stage 1 lower GI plus stage 1 upper GI) 2. Acute Minnesota Standard Risk GVHD requiring systemic immune suppressive therapy. 3. Acute GVHD developing after allogeneic hematopoietic cell transplantation using either bone marrow, peripheral blood, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity conditioning and myeloablative transplants are eligible. All allogeneic donor sources are permitted, including siblings, unrelated donors, human leukocyte antigen (HLA)-haploidentical related donors and umbilical cord blood. 4. Patients NOT receiving systemic immune suppressive therapy for treatment of active GVHD (topical skin and GI corticosteroids are allowed). 5. Ability to tolerate oral or enterically-administered medications. 6. Patients of all ages. 7. Absolute neutrophil count (ANC) greater than 500/┬ÁL. 8. Biopsy confirmation of GVHD is not required. Enrollment should not be delayed for biopsy or pathology results unless local institutional practice mandates biopsy confirmation to make a GVHD treatment decision. 9. Written informed consent and/or assent from patient, parent or guardian. 10. Collection of a 5 ml blood sample (red top for serum) from the patient for Ann Arbor Scoring and ready to be shipped immediately after randomization.

Exclusion Criteria

    1. Patients receiving sirolimus (for any indication including GVHD prophylaxis) within 14 days of screening for enrollment. 2. Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immune suppression. 3. Patients with acute GVHD developing after a donor lymphocyte infusion. 4. Active or recent (within 7 days) episode of transplant associated microangiopathy. 5. Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 6. Patients unlikely to be available for evaluation at the transplant center on Day 28 and 56 of therapy. 7. A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment. 8. Patients receiving corticosteroids for any indication within 7 days before the onset of acute GVHD, except the following: Stable replacement doses of corticosteroids for adrenal insufficiency are permitted (e.g. hydrocortisone total dose of 10-12 mg/m^2/day or prednisone 5-7.5mg daily or equivalent). Corticosteroids administered as premedication before transfusion of blood products or before intravenous medications to prevent infusion reactions are allowed. 9. Patients who are pregnant or breastfeeding. 10. Females of childbearing potential (FCBP) or a man who has sexual contact with a FCBP and is unwilling to use effective birth control for the duration of the study. 11. Patients on dialysis. 12. Patients on mechanical ventilation. 13. Patients with severe hepatic sinusoidal obstruction syndrome who in the judgment of the treating physician are not expected to have normalized bilirubin by Day 56 after enrollment. 14. Patients with a history of hypersensitivity to sirolimus or any component of the formulation.

Gender

All

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (112)

Study Location Distance Name Phone Email
Dana Farber Cancer InstituteBrigham Womens - Boston, Massachusetts 2.6 miles Joseph Antin MD None jantin@partners.org
Dana Farber Cancer InstituteBrigham Womens - Boston, Massachusetts 2.6 miles Joseph Antin MD None jantin@partners.org
Dana Farber Cancer InstituteBrigham Womens - Boston, Massachusetts 2.6 miles Joseph Antin MD None jantin@partners.org
Dana Farber Cancer InstituteBrigham Womens - Boston, Massachusetts 2.6 miles Joseph Antin MD None jantin@partners.org
Dana Farber Cancer InstituteBrigham Womens - Boston, Massachusetts 2.6 miles Joseph Antin MD None jantin@partners.org
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 270.8 miles David Porter MD None David.porter@uphs.upenn.edu
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 270.8 miles David Porter MD None David.porter@uphs.upenn.edu
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 270.8 miles David Porter MD None David.porter@uphs.upenn.edu
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 270.8 miles David Porter MD None David.porter@uphs.upenn.edu
University of Pennsylvania Cancer Center - Philadelphia, Pennsylvania 270.8 miles David Porter MD None David.porter@uphs.upenn.edu
Johns Hopkins - Baltimore, Maryland 357.9 miles Javier BolanosMeade MD None Fbolano2@jhmi.edu
Johns Hopkins - Baltimore, Maryland 357.9 miles Javier BolanosMeade MD None Fbolano2@jhmi.edu
Johns Hopkins - Baltimore, Maryland 357.9 miles Javier BolanosMeade MD None Fbolano2@jhmi.edu
Johns Hopkins - Baltimore, Maryland 357.9 miles Javier BolanosMeade MD None Fbolano2@jhmi.edu
Johns Hopkins - Baltimore, Maryland 357.9 miles Javier BolanosMeade MD None Fbolano2@jhmi.edu
Virginia Commonwealth University MCV Hospitals - Richmond, Virginia 473.4 miles John McCarty MD None jmccarty@mcvh-vcu.edu
Virginia Commonwealth University MCV Hospitals - Richmond, Virginia 473.4 miles John McCarty MD None jmccarty@mcvh-vcu.edu
Virginia Commonwealth University MCV Hospitals - Richmond, Virginia 473.4 miles John McCarty MD None jmccarty@mcvh-vcu.edu
Virginia Commonwealth University MCV Hospitals - Richmond, Virginia 473.4 miles John McCarty MD None jmccarty@mcvh-vcu.edu
Virginia Commonwealth University MCV Hospitals - Richmond, Virginia 473.4 miles John McCarty MD None jmccarty@mcvh-vcu.edu
West Virginia University Hospital - Morgantown, West Virginia 501.0 miles Michael Craig MD None craigm@wvuhealthcare.com
West Virginia University Hospital - Morgantown, West Virginia 501.0 miles Michael Craig MD None craigm@wvuhealthcare.com
West Virginia University Hospital - Morgantown, West Virginia 501.0 miles Michael Craig MD None craigm@wvuhealthcare.com
West Virginia University Hospital - Morgantown, West Virginia 501.0 miles Michael Craig MD None craigm@wvuhealthcare.com
West Virginia University Hospital - Morgantown, West Virginia 501.0 miles Michael Craig MD None craigm@wvuhealthcare.com
University Hospitals of ClevelandCase Western - Cleveland, Ohio 544.0 miles Hillard Lazarus MD None hillard.lazarus@case.edu
University Hospitals of ClevelandCase Western - Cleveland, Ohio 544.0 miles Hillard Lazarus MD None hillard.lazarus@case.edu
University Hospitals of ClevelandCase Western - Cleveland, Ohio 544.0 miles Hillard Lazarus MD None hillard.lazarus@case.edu
University Hospitals of ClevelandCase Western - Cleveland, Ohio 544.0 miles Hillard Lazarus MD None hillard.lazarus@case.edu
University Hospitals of ClevelandCase Western - Cleveland, Ohio 544.0 miles Hillard Lazarus MD None hillard.lazarus@case.edu
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Michelle Hamilton MD None michelle.hamilton@UHhospitals.org
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Michelle Hamilton MD None michelle.hamilton@UHhospitals.org
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Michelle Hamilton MD None michelle.hamilton@UHhospitals.org
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Michelle Hamilton MD None michelle.hamilton@UHhospitals.org
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Michelle Hamilton MD None michelle.hamilton@UHhospitals.org
Duke University Medical Center - Durham, North Carolina 608.4 miles Mitchell Horwitz MD None mitchell.horwitz@duke.edu
Duke University Medical Center - Durham, North Carolina 608.4 miles Mitchell Horwitz MD None mitchell.horwitz@duke.edu
Duke University Medical Center - Durham, North Carolina 608.4 miles Mitchell Horwitz MD None mitchell.horwitz@duke.edu
Duke University Medical Center - Durham, North Carolina 608.4 miles Mitchell Horwitz MD None mitchell.horwitz@duke.edu
Duke University Medical Center - Durham, North Carolina 608.4 miles Mitchell Horwitz MD None mitchell.horwitz@duke.edu
Ohio StateArthur G James Cancer Hospital - Columbus, Ohio 641.8 miles Steven Devine MD None steven.devine@osumc.edu
Ohio StateArthur G James Cancer Hospital - Columbus, Ohio 641.8 miles Steven Devine MD None steven.devine@osumc.edu
Ohio StateArthur G James Cancer Hospital - Columbus, Ohio 641.8 miles Steven Devine MD None steven.devine@osumc.edu
Ohio StateArthur G James Cancer Hospital - Columbus, Ohio 641.8 miles Steven Devine MD None steven.devine@osumc.edu
Ohio StateArthur G James Cancer Hospital - Columbus, Ohio 641.8 miles Steven Devine MD None steven.devine@osumc.edu
University of Michigan Medical Center - Ann Arbor, Michigan 644.6 miles Gregory Yanik MD None gyanik@umich.edu
University of Michigan Medical Center - Ann Arbor, Michigan 644.6 miles Gregory Yanik MD None gyanik@umich.edu
University of Michigan Medical Center - Ann Arbor, Michigan 644.6 miles Gregory Yanik MD None gyanik@umich.edu
University of Michigan Medical Center - Ann Arbor, Michigan 644.6 miles Gregory Yanik MD None gyanik@umich.edu
University of Michigan Medical Center - Ann Arbor, Michigan 644.6 miles Gregory Yanik MD None gyanik@umich.edu
Blood Marrow Transplant Program at Northside Hospital - Atlanta, Georgia 929.9 miles Scott Solomon MD None ssolomon@bmtga.com
Blood Marrow Transplant Program at Northside Hospital - Atlanta, Georgia 929.9 miles Scott Solomon MD None ssolomon@bmtga.com
Blood Marrow Transplant Program at Northside Hospital - Atlanta, Georgia 929.9 miles Scott Solomon MD None ssolomon@bmtga.com
Blood Marrow Transplant Program at Northside Hospital - Atlanta, Georgia 929.9 miles Scott Solomon MD None ssolomon@bmtga.com
Blood Marrow Transplant Program at Northside Hospital - Atlanta, Georgia 929.9 miles Scott Solomon MD None ssolomon@bmtga.com
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Madan Jagasia MD None madan.jagasia@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Madan Jagasia MD None madan.jagasia@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Madan Jagasia MD None madan.jagasia@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Madan Jagasia MD None madan.jagasia@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Madan Jagasia MD None madan.jagasia@vanderbilt.edu
Washington UniversityBarnes Jewish Hospital - Saint Louis, Missouri 1,039.5 miles Iskra Pusic MD None ipusic@dom.wustl.edu
Washington UniversityBarnes Jewish Hospital - Saint Louis, Missouri 1,039.5 miles Iskra Pusic MD None ipusic@dom.wustl.edu
Washington UniversityBarnes Jewish Hospital - Saint Louis, Missouri 1,039.5 miles Iskra Pusic MD None ipusic@dom.wustl.edu
Washington UniversityBarnes Jewish Hospital - Saint Louis, Missouri 1,039.5 miles Iskra Pusic MD None ipusic@dom.wustl.edu
Washington UniversityBarnes Jewish Hospital - Saint Louis, Missouri 1,039.5 miles Iskra Pusic MD None ipusic@dom.wustl.edu
University of Florida College of Medicine Shands - Gainesville, Florida 1,081.3 miles John Wingard MD None wingajr@ufl.edu
University of Florida College of Medicine Shands - Gainesville, Florida 1,081.3 miles John Wingard MD None wingajr@ufl.edu
University of Florida College of Medicine Shands - Gainesville, Florida 1,081.3 miles John Wingard MD None wingajr@ufl.edu
University of Florida College of Medicine Shands - Gainesville, Florida 1,081.3 miles John Wingard MD None wingajr@ufl.edu
University of Florida College of Medicine Shands - Gainesville, Florida 1,081.3 miles John Wingard MD None wingajr@ufl.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles William Hogan MD None hogan.william@mayo.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles William Hogan MD None hogan.william@mayo.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles William Hogan MD None hogan.william@mayo.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles William Hogan MD None hogan.william@mayo.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles William Hogan MD None hogan.william@mayo.edu
University of Minnesota - Minneapolis, Minnesota 1,120.0 miles Margaret MacMillan MD None macmi002@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.0 miles Margaret MacMillan MD None macmi002@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.0 miles Margaret MacMillan MD None macmi002@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.0 miles Margaret MacMillan MD None macmi002@umn.edu
University of Minnesota - Minneapolis, Minnesota 1,120.0 miles Margaret MacMillan MD None macmi002@umn.edu
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Joseph Pidala MD None joseph.pidala@moffitt.org
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Joseph Pidala MD None joseph.pidala@moffitt.org
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Joseph Pidala MD None joseph.pidala@moffitt.org
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Joseph Pidala MD None joseph.pidala@moffitt.org
H Lee Moffitt Cancer Center - Tampa, Florida 1,178.7 miles Joseph Pidala MD None joseph.pidala@moffitt.org
University of Kansas Hospital - Kansas City, Kansas 1,251.3 miles Sunil Abhyankar MD None sabhyankar@kumc.edu
University of Kansas Hospital - Kansas City, Kansas 1,251.3 miles Sunil Abhyankar MD None sabhyankar@kumc.edu
University of Kansas Hospital - Kansas City, Kansas 1,251.3 miles Sunil Abhyankar MD None sabhyankar@kumc.edu
University of Kansas Hospital - Kansas City, Kansas 1,251.3 miles Sunil Abhyankar MD None sabhyankar@kumc.edu
University of Kansas Hospital - Kansas City, Kansas 1,251.3 miles Sunil Abhyankar MD None sabhyankar@kumc.edu
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles None None None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles None None None
University of TexasMD Anderson Cancer Center - Houston, Texas 1,609.9 miles Amin Alousi MD None aalousi@mdanderson.org
University of TexasMD Anderson Cancer Center - Houston, Texas 1,609.9 miles Amin Alousi MD None aalousi@mdanderson.org
University of TexasMD Anderson Cancer Center - Houston, Texas 1,609.9 miles Amin Alousi MD None aalousi@mdanderson.org
University of TexasMD Anderson Cancer Center - Houston, Texas 1,609.9 miles Amin Alousi MD None aalousi@mdanderson.org
University of TexasMD Anderson Cancer Center - Houston, Texas 1,609.9 miles Amin Alousi MD None aalousi@mdanderson.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Marco Mielcarek MD None mmielcar@fhcrc.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Marco Mielcarek MD None mmielcar@fhcrc.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Marco Mielcarek MD None mmielcar@fhcrc.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Marco Mielcarek MD None mmielcar@fhcrc.org
Fred Hutchinson Cancer Research Center - Seattle, Washington 2,490.2 miles Marco Mielcarek MD None mmielcar@fhcrc.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Ryotaro Nakamura MD None rnakamura@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Ryotaro Nakamura MD None rnakamura@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Ryotaro Nakamura MD None rnakamura@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Ryotaro Nakamura MD None rnakamura@coh.org
City of Hope National Medical Center - Duarte, California 2,578.2 miles Ryotaro Nakamura MD None rnakamura@coh.org
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles McFarren MD None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles McFarren MD None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles McFarren MD None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles McFarren MD None None
Childrens Hospital Los Angeles - Los Angeles, California 2,595.3 miles McFarren MD None None

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