A Safety Study of SGN-CD19A for Leukemia and Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
First received: February 5, 2013
Last updated: January 28, 2016
Last verified: January 2016
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: May 2019
Estimated Primary Completion Date: February 2018 (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


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

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

Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

United States, Alabama
Children's Hospital of Alabama / University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Julia Adams    205-638-2984    jadams@peds.uab.edu   
Principal Investigator: Stuart Cramer, MD         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Aparna Tamhane    205-934-7167    aparna@uab.edu   
Contact: Ronda Carlisle    205-975-2511    rcarlisle@uab.edu   
Principal Investigator: Harry Erba, MD         
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, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Jaemee Bautista    626-218-3033    jbautista@coh.org   
Contact: Ibrahim Aldoss    626-256-4673    ialdoss@coh.org   
Principal Investigator: Ibrahim Aldoss, MD         
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mayo Clinic Clinical Trials Referral Office    507-538-7623      
Contact: Carol Fairchild    904-953-2941    fairchild.carol@mayo.edu   
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, MD         
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Bijal Shah    813-745-8212    bijal.shah@moffitt.org   
Contact: Kim Quach    813-745-4294    kim.quach@moffitt.org   
Principal Investigator: Bijal Shah, MD         
United States, Georgia
Children's Healthcare of Atlanta / Emory University Recruiting
Altanta, Georgia, United States, 30322
Contact: Melissa Schink    404-785-1645    Melissa.schink@choa.org   
Principal Investigator: Melinda Pauly, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Meghan Burke    617-643-5126    MBURKE19@PARTNERS.ORG   
Contact: Tanya Behnan    617-724-2689    ttbehnan@partners.org   
Principal Investigator: Amir Fathi, MD         
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Allison Hillner    617-632-5087    AllisonL_Hillner@DFCI.HARVARD.EDU   
Contact: Hilary Hall    617-632-6829    HilaryN_Hall@dfci.harvard.edu   
Principal Investigator: Lewis Silverman, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mekdes Getaneh    617-632-6840    Mekdes_Getaneh@dfci.harvard.edu   
Principal Investigator: Daniel DeAngelo, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Amina Ahmed    212-639-2696    ahmeda@mskcc.org   
Principal Investigator: Tanya Trippett, MD         
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, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Study Director: Eric Feldman, MD 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: January 28, 2016
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:
Burkitt Lymphoma
Leukemia, Lymphoid
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Experimental
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 08, 2016