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


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

Primary Outcomes

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

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..