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

Acute GvHD Clinical Trial

— ALD518-010  

Official title:

An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01530256
• Other study ID #: ALD518-CLIN-010
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: February 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acute GvHD

Intervention

Biological:
• ALD518
160 mg IV q 4 weeks for 4 doses
• ALD518
320 mg IV q 4 weeks for 4 doses
• ALD518
640 mg IV q 4 weeks for 2 doses

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio
United States	City of Hope	Duarte	California
United States	Loyola Medical Center	Maywood	Illinois
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events, Including Infections and Loss of Engraftment		Through Week 24
Primary	Number of Participants With Acute GVHD Response at 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.	Week 4
Secondary	Number of Participants With Relapse of Underlying Malignant Disease		Through Week 24
Secondary	Number of Participants With Overall Survival		Through Week 24
Secondary	Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score	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.	Up to 20 weeks