A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
NCT ID: NCT02614560
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2015-11-30
2017-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pre-allo (before stem cell transplant)
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
Fludarabine
30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan
Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine
Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
Post-allo (after stem cell transplant)
Post-allo vadastuximab talirine
vadastuximab talirine
Post-allo (after stem cell transplant) given on Day 1 of each cycle
Interventions
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Fludarabine
30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
Melphalan
Melphalan 140 mg/m2 intravenously, 2 days before the transplant
vadastuximab talirine
Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
vadastuximab talirine
Post-allo (after stem cell transplant) given on Day 1 of each cycle
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group status of 0 or 1
* Adequate baseline renal and hepatic function
* For Pre-allo Part A (before stem cell transplant): Relapsed or refractory AML (greater than 5% blasts)
* For Pre-allo Part A (before stem cell transplant): Availability of an HLA matched related or unrelated donor
* For Pre-allo Part A (before stem cell transplant): Eligible for an allogeneic hematopoietic stem cell transplant
* For Post-allo Part B: Transplant must have been performed with active AML (greater than 5% blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to 1,000 and platelet greater than or equal to 50,000)
* For Post-allo Part B: Treatment must begin at least 42 days, but no more than 100 days post-transplant.
Exclusion Criteria
* Inadequate lung function
* Previous central nervous system leukemia
* Any history of another metastatic malignancy
* Anti-leukemia treatment within14 days of study drug (other than hydroxyurea or 6-mercaptopurine), immunosuppressive therapy (except for GVHD treatment/prophylaxis in Part B), or investigational agents
* For Pre-allo Part A (before stem cell transplant): Partially matched donors (related or unrelated) and umbilical cord blood cells are excluded as the source of hematopoietic stem cells
* For Pre-allo Part A (before stem cell transplant): Prior alloSCT
* For Post-allo Part B: Active GVHD Grade 2 or higher
* For Post-allo Part B:History of veno-occlusive disease requiring defibrotide
* For Post-allo Part B: History of Grade 2 or higher hepatic GVHD
* For Post-allo Part B: Concurrent use of corticosteroids equivalent of prednisone at a dose of greater than 0.5 mg/kg
18 Years
75 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip Garfin, MD, PhD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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City of Hope National Medical Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN33A-003
Identifier Type: -
Identifier Source: org_study_id
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