Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

Phase 1

Terminated

• Conditions: Acute GvHD
• Interventions: Biological: ALD518

• Registration Number: NCT01530256
• Lead Sponsor: CSL Behring

Brief Summary

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-09
• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2014-06-23
• Disposition First Submitted QC: 2014-06-23
• Disposition First Posted: 2014-06-25
• Results First Submitted: 2021-01-20
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Glucocorticosteroid refractory acute GVHD Grade 2-4
• Prior corticosteroid therapy at > 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
• Karnofsky Performance Satus Scale ≥ 50%
• Adequate laboratory testing at screening

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Exclusion Criteria

• Subjects having Stage 1 skin acute GVHD
• Subjects with Stage 3 or 4 liver GVHD
• Prior EBV associated malignancy
• Prior or current Hepatitis B or C
• Prior or active tuberculosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALD518	ALD518	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events, Including Infections and Loss of Engraftment	Through Week 24
Number of Participants With Acute GVHD Response at Week 4	Week 4	Includes calculation of both complete and partial response. Complete response = functional grade of 0 for the GVHD grading in all evaluable organs. Partial response = improvement by one or more functional grades in one or more organs involved with GVHD symptoms without progression in others, or a very good partial response which is a partial response plus all of the following: (1) skin - active erythematous rash involving less than 25% of body surface, (2) liver - total bilirubin \<2 mg/dL or a 25% reduction from baseline (if \>2 mg/dL), (3) gut - greater than or equal to 75% reduction in daily stool volume.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Relapse of Underlying Malignant Disease	Through Week 24
Number of Participants With Overall Survival	Through Week 24
Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score	Up to 20 weeks	The FACT-BMT assesses bone marrow transplant related concerns. The total score is the sum of sub-scale scores for 5 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Bone Marrow Transplantation Subscale. Within each domain, a 5-point Likert-type scale (from 0-4) is used to measure the responses for each question. After taking into account reverse scores for questions constructed in a negative form, the subscale score for each domain is calculated by multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The final score for FACT-BMT ranges from 0 to 148. Higher scores indicate better quality of life.

Trial Locations

Locations (5)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Loyola Medical Center; 🇺🇸 Maywood, Illinois, United States

City of Hope; 🇺🇸 Duarte, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States