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A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients

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.
 
ClinicalTrials.gov Identifier: NCT02614560
Recruitment Status : Terminated
First Posted : November 25, 2015
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE November 20, 2015
First Posted Date  ICMJE November 25, 2015
Results First Submitted Date  ICMJE September 5, 2018
Results First Posted Date  ICMJE January 9, 2019
Last Update Posted Date January 9, 2019
Study Start Date  ICMJE November 2015
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Incidence of Adverse Events [ Time Frame: Approximately 1 year ]
    AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
  • Incidence of Laboratory Abnormalities [ Time Frame: Approximately 1 year ]
    Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
  • 1-year Survival Rate [ Time Frame: 12 months ]
    1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
  • Rate of MRD Negativity [ Time Frame: 30 days ]
    Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • Incidence of Adverse Events [ Time Frame: Through approximately 45 days following last dose ]
  • 1-year Survival Rate [ Time Frame: 12 months after the alloSCT ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Best Response of CR or CRi [ Time Frame: 9 weeks ]
    Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
  • Duration of Response [ Time Frame: 9 weeks ]
    Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
  • Overall Survival [ Time Frame: Approximately 96 weeks ]
    Defined as the time from the day of alloSCT to the date of death due to any cause.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
Official Title  ICMJE A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence With Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Brief Summary This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Fludarabine
    30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
  • Drug: Melphalan
    Melphalan 140 mg/m2 intravenously, 2 days before the transplant
  • Drug: vadastuximab talirine
    Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
  • Drug: vadastuximab talirine
    Post-allo (after stem cell transplant) given on Day 1 of each cycle
Study Arms  ICMJE
  • Experimental: Pre-allo (before stem cell transplant)
    Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
    Interventions:
    • Drug: Fludarabine
    • Drug: Melphalan
    • Drug: vadastuximab talirine
  • Experimental: Post-allo (after stem cell transplant)
    Post-allo vadastuximab talirine
    Intervention: Drug: vadastuximab talirine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
102
Actual Study Completion Date  ICMJE September 14, 2017
Actual Primary Completion Date February 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
  • 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 heart function
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614560
Other Study ID Numbers  ICMJE SGN33A-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phillip Garfin, MD, PhD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP