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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):
Seagen Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Fludarabine Drug: Melphalan Drug: vadastuximab talirine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2015
Actual Primary Completion Date : February 10, 2017
Actual Study Completion Date : September 14, 2017


Arm Intervention/treatment
Experimental: Pre-allo (before stem cell transplant)
Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)
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

Experimental: Post-allo (after stem cell transplant)
Post-allo vadastuximab talirine
Drug: vadastuximab talirine
Post-allo (after stem cell transplant) given on Day 1 of each cycle




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02614560


Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Ohio
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Phillip Garfin, MD, PhD Seagen Inc.
  Study Documents (Full-Text)

Documents provided by Seagen Inc.:
Study Protocol  [PDF] March 15, 2017
Statistical Analysis Plan  [PDF] March 15, 2017

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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02614560    
Other Study ID Numbers: SGN33A-003
First Posted: November 25, 2015    Key Record Dates
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019
Last Verified: December 2018
Keywords provided by Seagen Inc.:
acute myeloid leukemia
AML
antibody-drug conjugate
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Melphalan
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists