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Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD) (ALD518-010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01530256
Recruitment Status : Terminated (The trial was terminated in line with the endpoint committee charter.)
First Posted : February 9, 2012
Results First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute GvHD Biological: ALD518 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: ALD518 Biological: ALD518
160 mg IV q 4 weeks for 4 doses

Biological: ALD518
320 mg IV q 4 weeks for 4 doses

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

Primary Outcome Measures :
  1. Number of Participants With Adverse Events, Including Infections and Loss of Engraftment [ Time Frame: Through Week 24 ]
  2. Number of Participants With Acute GVHD Response at Week 4 [ Time Frame: 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 :
  1. Number of Participants With Relapse of Underlying Malignant Disease [ Time Frame: Through Week 24 ]
  2. Number of Participants With Overall Survival [ Time Frame: Through Week 24 ]
  3. Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01530256

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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Illinois
Loyola Medical Center
Maywood, Illinois, United States, 60153
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
CSL Behring
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Study Director: Javier San Martin, MD FRCP Alder Biopharmaceuticals, Inc.
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Responsible Party: CSL Behring Identifier: NCT01530256    
Other Study ID Numbers: ALD518-CLIN-010
First Posted: February 9, 2012    Key Record Dates
Results First Posted: February 17, 2021
Last Update Posted: February 17, 2021
Last Verified: February 2021
Keywords provided by CSL Behring:
steroid refractory