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The trial was terminated in line with the endpoint committee charter.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALD518 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALD518 | Biological | 160 mg IV q 4 weeks for 4 doses |
| |
| ALD518 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier San Martin, MD FRCP | Alder Biopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Loyola Medical Center |
The trial was terminated after only 3 participants received the 160 mg dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALD518 | ALD518: 160 mg intravenous (IV) once every (q) 4 weeks for 4 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALD518 | ALD518: 160 mg IV q 4 weeks for 4 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Including Infections and Loss of Engraftment | Posted | Number | participants | Through Week 24 |
|
|
Up to death or termination of study (approximately 139 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALD518 | ALD518: 160 mg IV q 4 weeks for 4 doses | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
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| ID | Term |
|---|---|
| C000604955 | clazakizumab |
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| Biological |
320 mg IV q 4 weeks for 4 doses |
|
| ALD518 | Biological | 640 mg IV q 4 weeks for 2 doses |
|
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 |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | 2 of 3 participants died before Week 4 so could not be assessed | Posted | Number | participants | Week 4 |
|
|
|
| Secondary | Number of Participants With Relapse of Underlying Malignant Disease | Posted | Number | participants | Through Week 24 |
|
|
|
| Secondary | Number of Participants With Overall Survival | Posted | Number | participants | 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. | Posted | Number | score on a scale | Up to 20 weeks |
|
|
|
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Retinal detachment | Eye disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Fungal infection | Infections and infestations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| International normalized ratio increased | Investigations | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | Systematic Assessment |
|
| Oedema peripheral | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Participant 1 (Week 20) |
|
| Participant 2 (Day 0) |
|