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

NCT01530256 | Terminated Phase 1 Results DMC

• 1 other identifier: ALD518-CLIN-010
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute GvHD

Keywords

allograph; steroid refractory

Outcome Measures

Primary Outcomes (2)

• 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

  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 Outcomes (3)

• 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

Study Arms (1)

ALD518

EXPERIMENTAL

Biological: ALD518

Interventions

ALD518 BIOLOGICAL

160 mg IV q 4 weeks for 4 doses

ALD518

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Loyola Medical Center

Maywood, Illinois, 60153, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

clazakizumab

Limitations and Caveats

Formal analyses were not conducted. Profiles of each enrolled subject were produced. Due to a limited number of samples, pharmacokinetics and anti-ALD518 antibodies analyses were not conducted.

Results Point of Contact

• Title: Study Director
• Organization: CSL Behring

clinicaltrials@cslbehring.com

610-878-4000

Study Officials

• Javier San Martin, MD FRCP

  Alder Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-02

Locations

US (5)