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

Phase 2TerminatedNCT01530256

CSL Behring3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute GvHD

Interventions

ALD518BIOLOGICAL

160 mg IV q 4 weeks for 4 doses

ALD518BIOLOGICAL

320 mg IV q 4 weeks for 4 doses

ALD518BIOLOGICAL

640 mg IV q 4 weeks for 2 doses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

City of Hope

Duarte, California, United States

Loyola Medical Center

Maywood, Illinois, United States

Washington University

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events, Including Infections and Loss of Engraftment

Time frame: 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.

Time frame: Week 4

Secondary Outcomes

Number of Participants With Relapse of Underlying Malignant Disease

Time frame: Through Week 24

Number of Participants With Overall Survival

Time frame: Through Week 24

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.

Time frame: Up to 20 weeks

Data from ClinicalTrials.gov

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