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Purpose

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).

Condition

Eligibility

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

Inclusion 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.

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 transplant. - Planned use of cyclophosphamide after HCT for GVHD prophylaxis. - Planned haploidentical donor.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AAT (low dose) 		Open label. AAT is a lyophilized product for intravenous (IV) administration
  • Biological: AAT
    AAT is a lyophilized product for IV administration.
    Other names:
    • Alpha-1 proteinase inhibitor
    • Respreeza
Experimental
AAT (medium dose) 		Open label. AAT is a lyophilized product for IV administration
  • Biological: AAT
    AAT is a lyophilized product for IV administration.
    Other names:
    • Alpha-1 proteinase inhibitor
    • Respreeza
Experimental
AAT (high dose) 		Open label. AAT is a lyophilized product for IV administration
  • Biological: AAT
    AAT is a lyophilized product for IV administration.
    Other names:
    • Alpha-1 proteinase inhibitor
    • Respreeza
Experimental
AAT (selected dose from open-label) 		Double-blind. AAT is a lyophilized product for IV administration
  • Biological: AAT
    AAT is a lyophilized product for IV administration.
    Other names:
    • Alpha-1 proteinase inhibitor
    • Respreeza
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
+1 610-878-4697
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.