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A Safety Study of SGN-CD19A for B-Cell Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01786135
First Posted: February 7, 2013
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
February 5, 2013
February 7, 2013
October 19, 2017
February 2013
August 2015   (Final data collection date for primary outcome measure)
  • Incidence of adverse events [ Time Frame: Through 1 month post last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month post last dose ]
Same as current
Complete list of historical versions of study NCT01786135 on ClinicalTrials.gov Archive Site
  • Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through up to approximately 6 week post last dose ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ]
  • Blood concentration of SGN-CD19A and metabolites [ Time Frame: Through up to approximately 6 weeks post last dose ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through up to approximately 6 weeks post last dose ]
  • Objective response according to revised response criteria for malignant lymphoma (Cheson 2007) [ Time Frame: Through 1 month post last dose ]
  • Duration of response [ Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months ]
  • Overall survival [ Time Frame: Until death or study closure, an expected average of 1 year ]
  • Blood concentration of SGN-CD19A and metabolites [ Time Frame: Cycles 1, 2, and 4: predose, 30 minutes, and 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 ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Predose in most cycles and 1 month post last dose ]
Not Provided
Not Provided
 
A Safety Study of SGN-CD19A for B-Cell Lymphoma
A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
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)
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Burkitt Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell
  • Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Drug: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Experimental: SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
Intervention: Drug: SGN-CD19A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 16, 2017
August 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01786135
SGN19A-002
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Ana Kostic, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2017

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