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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01530256
First Posted: February 9, 2012
Last Update Posted: September 19, 2017
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.
Information provided by (Responsible Party):
Vitaeris INC
  Purpose
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 Intervention Phase
Acute GvHD Biological: ALD518 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Vitaeris INC:

Primary Outcome Measures:
  • Number of participants with Adverse Events, including infections and loss of engraftment [ Time Frame: Through Week 24 ]
  • Acute GVHD Response at Week 4 [ Time Frame: Week 4 ]
    Includes calculation of both complete and partial response


Secondary Outcome Measures:
  • Relapse of underlying malignant disease [ Time Frame: Through Week 24 ]
  • Overall survival [ Time Frame: Through Week 24 ]
    Measured at 100 days post-first infusion, 6 months post-infusion and time of death

  • Change in Patient Reported Outcomes [ Time Frame: Through Week 24 ]
    As measured by the FACT-BMT.


Enrollment: 3
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01530256


Locations
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
Vitaeris INC
Investigators
Study Director: Javier San Martin, MD FRCP Alder Biopharmaceuticals, Inc.
  More Information

Responsible Party: Vitaeris INC
ClinicalTrials.gov Identifier: NCT01530256     History of Changes
Other Study ID Numbers: ALD518-CLIN-010
First Submitted: February 6, 2012
First Posted: February 9, 2012
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Vitaeris INC:
allograph
steroid refractory