Skip to main content
MedPathMedPath Home
Clinical Trials/2024-511164-92-00
2024-511164-92-00
Recruiting
Phase 2/3

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)

CSL Behring LLC9 sites in 3 countries45 target enrollmentStarted: May 22, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2/3
Status
Recruiting
Enrollment
45
Locations
9
Primary Endpoint
The time to Grade II-IV aGVHD or death through 180 days after hematopoietic cell transplantation (HCT).
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Primary objective is to evaluate the efficacy of AAT at the selected dose for the prevention of acute GVHD following HCT.

Study Design

Allocation
Randomized
Primary Purpose
Double-blind, Placebo-controlled Part for Prevention of aGVHD
Masking
Double (Carer, Investigator, Subject, Monitor, Analyst)

Eligibility Criteria

Ages
0 years to 65+ years (18-64 Years, 65+ Years, 0-17 Years)
Accepts Healthy Volunteers
Yes

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.
  • •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.

Outcomes

Primary Outcomes

The time to Grade II-IV aGVHD or death through 180 days after hematopoietic cell transplantation (HCT).

The time to Grade II-IV aGVHD or death through 180 days after hematopoietic cell transplantation (HCT).

Secondary Outcomes

  • Proportion of subjects with lower GI aGVHD or Grade III-IV aGVHD in any organ. Through 180 days after HCT.
  • Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3. Through Day 60 after HCT.
  • Proportion of subjects with Grade II-IV aGVHD or death. Through 100 and 180 days after HCT.
  • Proportion of subjects with lower GI aGVHD. Through Days 60, 100 and 180 after HCT.
  • Deaths (relapse and nonrelapse-related). Within 180, 365, and 730 days after HCT.
  • Proportion of subjects with severe infections defined by NCI-CTCAE ≥ Grade 3. Through 100 and 180 days after HCT.
  • Proportion of subjects with Grade III-IV aGVHD or death. Through Days 60, 100, and 180 days after HCT.
  • Proportion of subjects with moderate-to-severe chronic GVHD. Within 180, 365, 545, and 730 days after HCT.
  • Proportion of subjects who have discontinued immune suppression therapies including standard-of-care GVHD prophylaxis and steroid treatment. Within 180 and 365 days after HCT.
  • Proportion of subjects with relapse of primary malignancies. Through 180, 365, and 730 days after HCT.
  • Time to neutrophil engraftment. Through 365 days after HCT.
  • Time to GVHD relapse-free survival. Within 365 and 730 days after HCT.
  • Proportion of subjects with Grade II-IV aGVHD with an overall (complete + partial) response, complete response and partial response. Approximately 4 weeks after the initiation of systemic steroids during 8-week Treatment Period
  • Percent of subjects with study drug-related adverse events. Up to 365 days after HCT.
  • Maximum concentration (Cmax) of AAT. Before and up to 72 after infusion of AAT.
  • Area under the concentration curve for AAT. Before and up to 72 after infusion of AAT.
  • Clearance of AAT. Before and up to 72 after infusion of AAT.
  • Volume of distribution for AAT. Before and up to 72 after infusion of AAT.
  • Ctrough of AAT. Before and up to 72 after infusion of AAT.

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Study Director

Scientific

CSL Behring LLC

Study Sites (9)

Loading locations...

Similar Trials

Completed
Not Applicable
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis
2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
Not yet recruiting
Not Applicable
QTc Assessment in a Single-Dose Study of Hydronidone Capsules
NCT07263152Beijing Continent Pharmaceutical Co, Ltd.48
Not yet recruiting
Phase 4
Impact of Angiotensin Receptor Blocker in aortic stenosis
2024-518389-28-00Odense University Hospital139
Recruiting
Phase 2
Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727
2024-516293-29-01Taiho Oncology Inc.79
Not yet recruiting
Phase 2
A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)
2024-515610-41-00Angitia Inc. Ltd.260