The safety and efficacy of Alpha-1 Antitrypsin (AAT) for the prevention of graft-versus-host disease (GVHD) in patients receiving hematopoietic cell transplant

Phase 1

• Conditions: Graft versus host disease; MedDRA version: 20.1 Level: PT Classification code 10018651 Term: Graft versus host disease System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-000329-29-ES
• Lead Sponsor: CSL Behring LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 310

Inclusion Criteria

1. Male or female subjects, =12 years of age, undergoing HCT for hematological malignancies, including leukemia, lymphoma and multiple myeloma
2. Planned myeloablative conditioning regimen
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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
3. Planned umbilical cord blood (UCB) transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified