RECRUITING

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

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 study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).

Official Title

A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft-versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)

Quick Facts

Study Start:2019-03-27
Study Completion:2031-09-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03805789

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. * Male or female participants, \>=12 years of age (\>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
  2. * Planned myeloablative conditioning regimen.
  3. * Participants must have a related or unrelated donor as follows:
  4. * Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing.
  5. * Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
  1. * Prior autologous or allogeneic HCT.
  2. * T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin \[ATG\], alemtuzumab) for GVHD prophylaxis.
  3. * Planned umbilical cord blood transplant.
  4. * Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
  5. * Planned haploidentical donor.

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Study Physician
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85258
United States
Johns Hopkins Hospital
Saint Petersburg, Florida, 33701
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The University of Texas-MD Anderson Cancer Center
San Antonio, Texas, 77030
United States
University of Utah Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
University of Virginia Health System
Charlottesville, Virginia, 22903
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Physician, STUDY_DIRECTOR, CSL Behring

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 Date2019-03-27
Study Completion Date2031-09-28

Study Record Updates

Study Start Date2019-03-27
Study Completion Date2031-09-28

Terms related to this study

Additional Relevant MeSH Terms

  • Acute-graft-versus-host Disease