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Trial record 1 of 1 for:    NCT01530256
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Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD) (ALD518-010)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01530256
First received: February 6, 2012
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Further study details as provided by Alder Biopharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of participants with Adverse Events, including infections and loss of engraftment [ Time Frame: Through Week 24 ] [ Designated as safety issue: Yes ]
  • Acute GVHD Response at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Includes calculation of both complete and partial response


Secondary Outcome Measures:
  • Relapse of underlying malignant disease [ Time Frame: Through Week 24 ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Through Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As measured by the FACT-BMT.


Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
St. 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
Alder Biopharmaceuticals, Inc.
Investigators
Study Director: Javier San Martin, MD FRCP Alder Biopharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01530256     History of Changes
Other Study ID Numbers: ALD518-CLIN-010
Study First Received: February 6, 2012
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alder Biopharmaceuticals, Inc.:
allograph
steroid refractory

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013