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

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).

Conditions

Acute-graft-versus-host Disease

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Acute-graft-versus-host Disease
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth Scottsdale Shea Medical Center, Scottsdale, Arizona, United States, 85258

Saint Petersburg

Johns Hopkins Hospital, Saint Petersburg, Florida, United States, 33701

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Westwood

University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Ann Arbor

University of Michigan Medical Center, Ann Arbor, Michigan, United States, 48109

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27705

Cleveland

University Hospital Cleveland Medical Center, Cleveland, Ohio, United States, 44106

San Antonio

The University of Texas-MD Anderson Cancer Center, San Antonio, Texas, United States, 77030

Salt Lake City

University of Utah Primary Children's Hospital, Salt Lake City, Utah, United States, 84113

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Planned myeloablative conditioning regimen.
  • * Participants must have a related or unrelated donor as follows:
  • * 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.
  • * 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.
  • * Prior autologous or allogeneic HCT.
  • * 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.
  • * Planned umbilical cord blood transplant.
  • * Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
  • * Planned haploidentical donor.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Physician, STUDY_DIRECTOR, CSL Behring

Study Record Dates

2031-09-28