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

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CSL Behring

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Acute-graft-versus-host Disease

Treatments

Biological: Alpha-1 antitrypsin (AAT)
Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03805789
2018-000329-29 (EudraCT Number)
CSL964_2001

Details and patient eligibility

About

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center, placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an allogeneic hematopoietic cell transplant (HCT).

Enrollment

310 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects, ≥12 years of age (≥ 18 years of age for subjects at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms
  • Planned myeloablative conditioning regimen

Exclusion criteria

  • 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 (UCB) transplant

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

310 participants in 5 patient groups, including a placebo group

AAT (low dose)
Experimental group
Description:
Open label. Alpha-1 antitrypsin (AAT) is a lyophilized product for intravenous administration
Treatment:
Biological: Alpha-1 antitrypsin (AAT)
AAT (medium dose)
Experimental group
Description:
Open label. AAT is a lyophilized product for intravenous administration
Treatment:
Biological: Alpha-1 antitrypsin (AAT)
AAT (high dose)
Experimental group
Description:
Open label. AAT is a lyophilized product for intravenous administration
Treatment:
Biological: Alpha-1 antitrypsin (AAT)
AAT (selected dose from open-label)
Experimental group
Description:
Double-blind. AAT is a lyophilized product for intravenous administration
Treatment:
Biological: Alpha-1 antitrypsin (AAT)
Placebo
Placebo Comparator group
Description:
Albumin solution administered intravenously
Treatment:
Biological: Placebo

Trial contacts and locations

35

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Central trial contact

Trial Registration Coordinator

Data sourced from clinicaltrials.gov

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