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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786135
• Other study ID #: SGN19A-002
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2013
• Last updated: October 17, 2017
• Start date: February 2013
• Est. completion date: February 16, 2017

Study information

• Verified date: June 2017
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 16, 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• SGN-CD19A
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	City of Hope National Medical Center	Duarte	California
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford Cancer Center	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Through 1 month post last dose
Primary	Incidence of laboratory abnormalities		Through 1 month post last dose
Secondary	Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)		Through up to approximately 6 week post last dose
Secondary	Duration of response		Until disease progression or start of new anticancer treatment, an expected average of 6 months
Secondary	Overall survival		Until death or study closure, an expected average of 1 year
Secondary	Blood concentration of SGN-CD19A and metabolites		Through up to approximately 6 weeks post last dose
Secondary	Incidence of antitherapeutic antibodies		Through up to approximately 6 weeks post last dose