Overview

This trial is active, not recruiting.

Conditions burkitt lymphoma, lymphoma, follicular, lymphoma, large b-cell, diffuse, lymphoma, mantle-cell, precursor b-cell lymphoblastic leukemia-lymphoma
Treatment sgn-cd19a
Phase phase 1
Target CD19
Sponsor Seattle Genetics, Inc.
Start date February 2013
End date August 2015
Trial size 64 participants
Trial identifier NCT01786135, SGN19A-002

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)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
sgn-cd19a
SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 12 years old.

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)

Additional Information

Official title A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seattle Genetics, Inc..
Location data was received from the National Cancer Institute and was last updated in October 2016.