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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute GvHD
- Sponsor
- CSL Behring
- Enrollment
- 3
- Locations
- 5
- Primary Endpoint
- Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
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 Outcomes
- 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)