A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01786096
First received: February 5, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).


Condition Intervention Phase
Burkitt Lymphoma
Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Drug: SGN-CD19A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response according to modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through 1 month post last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 3 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 6 months ] [ Designated as safety issue: No ]
  • Blood concentrations of SGN-CD19A and metabolites [ Time Frame: Cycles 1, 2, and 4: predose, 30 minutes, and up to 2, 4, 8, 24, 72, 120, 168, and 336 hours post dose start; All other cycles: predose, 30 minutes, and 168 and 336 hours post dose start; and 1 month post last dose ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Predose in most cycles and 1 month post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
Drug: SGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
  • Eastern Cooperative Oncology Group status of 2 or lower
  • Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
  • Measurable disease

Exclusion Criteria:

-Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786096

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Stephanie Biggers    205-975-2944    sbiggers@uab.edu   
Principal Investigator: Uma Borate         
University of Alabama at Birmingham / Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Julia Adams    205-638-2984    jadams@peds.uab.edu   
Principal Investigator: Stuart Cramer         
United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Arpita Patel    480-301-7471    patel.arpita@mayo.edu   
Principal Investigator: Raoul Tibes, M.D.         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Brianna Brophy    626-256-4673 ext 89448    brbrophy@coh.org   
Principal Investigator: Robert Chen, M.D.         
United States, Florida
Mayo Clinic Cancer Center Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mayo Clinic Clinical Trials ReferralOffice    507-538-7623      
Principal Investigator: James Foran, MD         
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Jennifer Flanary    727-767-6466    Jennifer.Flanary@allkids.org   
Principal Investigator: Gregory Hale, M.D.         
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Jennifer Gemmer    813-745-6934    Jennifer.Gemmer@moffitt.org   
Principal Investigator: Bijal Shah, M.D.         
United States, Georgia
Children's Healthcare of Atlanta / Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Melissa Schink    404-785-1645    Melissa.schink@choa.org   
Principal Investigator: Todd Cooper, D.O.         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Meghan Burke    617-643-5126    MBURKE19@PARTNERS.ORG   
Principal Investigator: Amir Fathi, M.D.         
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Hilary Hall    617-632-6829    HilaryN_Hall@dfci.harvard.edu   
Principal Investigator: Lewis Silverman, M.D.         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Stacie-Ann Sammott    617-582-8287    Stacie-AnnS_Sammott@DFCI.HARVARD.EDU   
Principal Investigator: Daniel DeAngelo, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Emily Willard    646-888-5821    willarde@mskcc.org   
Principal Investigator: Tanya Trippett, M.D.         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Courtney Blank    513-803-3255    Courtney.Blank@cchmc.org   
Principal Investigator: Maureen O'Brien, M.D.         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Tina Albertson, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01786096     History of Changes
Other Study ID Numbers: SGN19A-001
Study First Received: February 5, 2013
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Burkitt Lymphoma
Antibodies, Monoclonal
Antibody-Drug Conjugate
B-Lineage Acute Lymphoblastic Leukemia
B-Lineage Lymphoblastic Lymphoma
Burkitt Leukemia
Monomethylauristatin F
Antigens, CD19
Drug Therapy

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Leukemia
Burkitt Lymphoma
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Neoplasms, Experimental

ClinicalTrials.gov processed this record on September 18, 2014