A Safety Study of SGN-CD19A for B-Cell 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:
NCT01786135
First received: February 5, 2013
Last updated: September 30, 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 patients with relapsed or refractory B-lineage non-Hodgkin lymphoma (B-NHL)


Condition Intervention Phase
Burkitt Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
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 Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

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 revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through up to approximately 6 week 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 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ] [ Designated as safety issue: No ]
  • Blood concentration of SGN-CD19A and metabolites [ Time Frame: Through up to approximately 6 weeks post last dose ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through up to approximately 6 weeks post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 175
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Drug: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade 3, diffuse large B-cell lymphoma (DLBCL), including transformed follicular histology, Burkitt lymphoma, or B-lineage lymphoblastic lymphoma
  • Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy. Patients with DLBCL or follicular lymphoma Grade 3 must have also received intensive salvage therapy.
  • Eastern Cooperative Oncology Group status of 0 or 1
  • Measurable disease

Exclusion Criteria:

- Allogeneic stem cell transplant (SCT)

  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: NCT01786135

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: Andres Forero-Torres, MD         
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.         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5821
Contact: Sabata Lund    650-725-6432    sclund@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
United States, Florida
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, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Alexandra Jacob    646-449-1304    jacoba@mskcc.org   
Principal Investigator: Craig Moskowitz, M.D.         
United States, Texas
MD Anderson Cancer Center /The University of Texas Recruiting
Houston, Texas, United States, 77030-4000
Contact: Emily Wesson    713-745-3702    ETWesson@mdanderson.org   
Principal Investigator: Michelle Fanale, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Ana Kostic, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01786135     History of Changes
Other Study ID Numbers: SGN19A-002
Study First Received: February 5, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD19
B-Lineage Lymphoblastic Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
B-Cell Lymphoma
Drug Therapy
Monomethylauristatin F
Follicular Lymphoma Grade 3

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Burkitt Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
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 October 01, 2014