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

This study is currently recruiting participants.
Verified March 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: March 27, 2014
Last verified: March 2014

February 5, 2013
March 27, 2014
February 2013
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
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 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 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: 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 ] [ 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 ]
Same as current
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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; dose range: 0.5-6 mg/kg
Experimental: SGN-CD19A
SGN-CD19A (IV) once every 21 days; dose range 0.5-6 mg/kg
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.
 
Recruiting
120
December 2016
December 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)

Both
12 Years and older
No
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
United States
 
NCT01786135
SGN19A-002
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Ana Kostic, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
March 2014

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