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Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Primary Purpose

Chronic GVHD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sirolimus + calcineurin inhibitor + prednisone
Sirolimus + prednisone
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic GVHD focused on measuring Chronic Graft-versus-Host Disease (cGVHD)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received < 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ≤ 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis).
  • Patient or guardian willing and able to provide informed consent.
  • Stated willingness to use contraception in women of childbearing potential.
  • Stated willingness of patient to comply with study procedures and reporting requirements.

Exclusion Criteria:

  • Patients with late persistent acute GVHD or recurrent acute GVHD only.
  • Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.
  • Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable).
  • Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents.
  • Receiving therapy for chronic GVHD for more than 16 weeks.
  • Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
  • Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m^2) = eCCr x 1.73/Body Surface Area (BSA) (m^2); Children: eCCr (mL/min/1.73 m^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years).
  • Inability to tolerate oral medications.
  • Absolute neutrophil count less than 1500 per microliter.
  • Requirement for platelet transfusions.
  • Pregnancy (positive serum β-HCG) or breastfeeding.
  • Receiving any treatment for persistent, progressive or recurrent malignancy.
  • Progressive or recurrent malignancy defined other than by quantitative molecular assays.
  • Known hypersensitivity to sirolimus.

Sites / Locations

  • City of Hope National Medical Center
  • University of California San Diego Medical Center
  • Stanford Hospital and Clinics
  • University of Florida College of Medicine (Shands)
  • Emory University
  • Blood & Marrow Transplant Program at Northside Hospital
  • University of Chicago
  • University of Kansas Hospital
  • Johns Hopkins University
  • University of Michigan Medical Center
  • University of Minnesota
  • Washington University, Barnes Jewish Hospital
  • University of Nebraska Medical Center
  • Hackensack University Medical Center
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Mayo Clinic
  • University of North Carolina Hospital at Chapel Hill
  • Duke University Medical Center
  • Jewish Hospital BMT Program
  • University Hospitals of Cleveland/ Case Western
  • University of Oklahoma Medical Center
  • Oregon Health & Science University (A) and (P)
  • University of Pennsylvania Cancer Center
  • Western Pennsylvania Hospital
  • Medical University of South Carolina
  • University of Texas/MD Anderson CRC
  • Texas Transplant Institute
  • Virginia Commonwealth University/MCV Hospitals
  • Fred Hutchinson Cancer Research Center
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

calcineurin inhibitor

Sirolimus and prednisone

Arm Description

Sirolimus + calcineurin inhibitor + prednisone

Sirolimus + prednisone

Outcomes

Primary Outcome Measures

Proportion of Participants With Treatment Success
Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.

Secondary Outcome Measures

Percentage of Participants With Overall Survival
Overall survival is defined as survival of death from any cause.
Percentage of Participants With Progression-free Survival
Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.
Percentage of Participants With Failure-free Survival
Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.
Percentage of Participants With Relapse
Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.
Percentage of Participants With Secondary Immunosuppressive Therapy Initiated
The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.
Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years
The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.
Prednisone Dose
Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.
Change in Prednisone Dose From Baseline
Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.
Serum Creatinine Level
Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.
Change in Serum Creatinine Level From Baseline
Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.
Patient-reported Chronic GVHD Severity
Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.
Provider-reported Chronic GVHD Severity
Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.
NIH Consensus Criteria Chronic GVHD Severity
Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.
SF-36 Physical Component Summary
The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
SF-36 Mental Component Summary
The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
FACT-BMT Score
The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.

Full Information

First Posted
April 16, 2010
Last Updated
November 13, 2018
Sponsor
Medical College of Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program
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1. Study Identification

Unique Protocol Identification Number
NCT01106833
Brief Title
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
Official Title
A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
Detailed Description
Background: Chronic GVHD is a medical condition that can become very serious. Chronic GVHD is a common development after allogeneic transplant that occurs when the donor cells attack and damage tissues. The primary purpose of this study is to compare treatment regimens that contain sirolimus without a calcineurin inhibitor to a comparator regimen of sirolimus with a calcineurin inhibitor and evaluate how well chronic GVHD responds to treatment. The combinations of medications in this study are: Sirolimus + calcineurin inhibitor + prednisone Sirolimus + prednisone The goal is to select a treatment regimen for further comparison in the Phase III trial. Design Narrative: The intent is to enroll subjects at the start of initial therapy for chronic GVHD, or before their chronic GVHD is refractory to glucocorticoid therapy, or is chronically dependent upon glucocorticoid therapy and multiple secondary systemic immunosuppressive agents. Patients will be stratified by transplant center and will be randomized to one of two arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic GVHD
Keywords
Chronic Graft-versus-Host Disease (cGVHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calcineurin inhibitor
Arm Type
Active Comparator
Arm Description
Sirolimus + calcineurin inhibitor + prednisone
Arm Title
Sirolimus and prednisone
Arm Type
Experimental
Arm Description
Sirolimus + prednisone
Intervention Type
Drug
Intervention Name(s)
Sirolimus + calcineurin inhibitor + prednisone
Other Intervention Name(s)
Rapamune, Prograf, Neorall, Gengraf
Intervention Description
The target serum level for sirolimus is 3-12 ng/mL. The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL. Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.
Intervention Type
Drug
Intervention Name(s)
Sirolimus + prednisone
Other Intervention Name(s)
Rapamune
Intervention Description
The target serum level for sirolimus is 3-12 ng/mL. Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day.
Primary Outcome Measure Information:
Title
Proportion of Participants With Treatment Success
Description
Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.
Time Frame
6 months and 24 months post-randomization
Secondary Outcome Measure Information:
Title
Percentage of Participants With Overall Survival
Description
Overall survival is defined as survival of death from any cause.
Time Frame
6 months and 24 months post-randomization
Title
Percentage of Participants With Progression-free Survival
Description
Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.
Time Frame
6 months and 24 months post-randomization
Title
Percentage of Participants With Failure-free Survival
Description
Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.
Time Frame
6 months and 24 months post-randomization
Title
Percentage of Participants With Relapse
Description
Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.
Time Frame
6 months and 24 months post-randomization
Title
Percentage of Participants With Secondary Immunosuppressive Therapy Initiated
Description
The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.
Time Frame
6 months and 24 months post-randomization
Title
Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years
Description
The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.
Time Frame
2 years post-randomization
Title
Prednisone Dose
Description
Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.
Time Frame
Baseline, 6 months, and 1 year post-randomization
Title
Change in Prednisone Dose From Baseline
Description
Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.
Time Frame
6 months and 1 year post-randomization
Title
Serum Creatinine Level
Description
Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.
Time Frame
Baseline, 6 months, and 1 year post-randomization
Title
Change in Serum Creatinine Level From Baseline
Description
Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.
Time Frame
6 months and 1 year post-randomization
Title
Patient-reported Chronic GVHD Severity
Description
Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.
Time Frame
Baseline, 6 months, 1 year, and 2 years post-randomization
Title
Provider-reported Chronic GVHD Severity
Description
Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.
Time Frame
Baseline, 6 months, 1 year, and 2 years post-randomization
Title
NIH Consensus Criteria Chronic GVHD Severity
Description
Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.
Time Frame
Baseline, 6 months, 1 year, and 2 years post-randomization
Title
SF-36 Physical Component Summary
Description
The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
Time Frame
Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization
Title
SF-36 Mental Component Summary
Description
The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.
Time Frame
Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization
Title
FACT-BMT Score
Description
The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.
Time Frame
Baseline, 2 months, 6 months, 1 year, and 2 years post-randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received < 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ≤ 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis). Patient or guardian willing and able to provide informed consent. Stated willingness to use contraception in women of childbearing potential. Stated willingness of patient to comply with study procedures and reporting requirements. Exclusion Criteria: Patients with late persistent acute GVHD or recurrent acute GVHD only. Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day. Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable). Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents. Receiving therapy for chronic GVHD for more than 16 weeks. Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies. Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m^2) = eCCr x 1.73/Body Surface Area (BSA) (m^2); Children: eCCr (mL/min/1.73 m^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years). Inability to tolerate oral medications. Absolute neutrophil count less than 1500 per microliter. Requirement for platelet transfusions. Pregnancy (positive serum β-HCG) or breastfeeding. Receiving any treatment for persistent, progressive or recurrent malignancy. Progressive or recurrent malignancy defined other than by quantitative molecular assays. Known hypersensitivity to sirolimus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Horowitz, MD
Organizational Affiliation
Center for International Blood and Marrow Transplant Research
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Florida College of Medicine (Shands)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Blood & Marrow Transplant Program at Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2967
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University, Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10174
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
University of North Carolina Hospital at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7305
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Jewish Hospital BMT Program
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
University Hospitals of Cleveland/ Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5061
Country
United States
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University (A) and (P)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas/MD Anderson CRC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University/MCV Hospitals
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5156
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Findings will be published in a manuscript
IPD Sharing Time Frame
Within 6 months of official study closure at participating sites.
IPD Sharing Access Criteria
Available to the public
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/
Citations:
PubMed Identifier
16338616
Citation
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.
Results Reference
background
PubMed Identifier
29954931
Citation
Carpenter PA, Logan BR, Lee SJ, Weisdorf DJ, Johnston L, Costa LJ, Kitko CL, Bolanos-Meade J, Sarantopoulos S, Alousi AM, Abhyankar S, Waller EK, Mendizabal A, Zhu J, O'Brien KA, Lazaryan A, Wu J, Nemecek ER, Pavletic SZ, Cutler CS, Horowitz MM, Arora M; BMT CTN.. A phase II/III randomized, multicenter trial of prednisone/sirolimus versus prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft-versus-host disease: BMT CTN 0801. Haematologica. 2018 Nov;103(11):1915-1924. doi: 10.3324/haematol.2018.195123. Epub 2018 Jun 28.
Results Reference
derived
Links:
URL
https://bethematch.org/
Description
National Marrow Donor Program

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Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

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