Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD) (ALD518-010)
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute GvHD | Biological: ALD518 | Phase 1 Phase 2 |
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 |
- 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 [ 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.
- 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 [ 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.

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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

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 ClinicalTrials.gov identifier (NCT number): NCT01530256
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 |
Study Director: | Javier San Martin, MD FRCP | Alder Biopharmaceuticals, Inc. |
Responsible Party: | CSL Behring |
ClinicalTrials.gov 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 |
allograph steroid refractory |