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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AAT (low dose) 		Open label. Alpha-1 antitrypsin (AAT) is a lyophilized product for intravenous administration
  • Biological: Alpha-1 antitrypsin (AAT)
    Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
    Other names:
    • Alpha-1 proteinase inhibitor
Experimental
AAT (medium dose) 		Open label. AAT is a lyophilized product for intravenous administration
  • Biological: Alpha-1 antitrypsin (AAT)
    Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
    Other names:
    • Alpha-1 proteinase inhibitor
Experimental
AAT (high dose) 		Open label. AAT is a lyophilized product for intravenous administration
  • Biological: Alpha-1 antitrypsin (AAT)
    Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
    Other names:
    • Alpha-1 proteinase inhibitor
Experimental
AAT (selected dose from open-label) 		Double-blind. AAT is a lyophilized product for intravenous administration
  • Biological: Alpha-1 antitrypsin (AAT)
    Alpha-1 antitrypsin is a lyophilized product for intravenous administration.
    Other names:
    • Alpha-1 proteinase inhibitor
Placebo Comparator
Placebo 		Albumin solution administered intravenously
  • Biological: Placebo
    Albumin solution administered intravenously

Recruiting Locations

University of Kansas Cancer Center
Westwood, Kansas 66205
Contact:
Use Central Contact

More Details

Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
610-878-4000
clinicaltrials@cslbehring.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.