Clinical trial NCT01786135: A Safety Study of SGN-CD19A for B-Cell Lymphoma
Official title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burkitt Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Keywords: Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD19
B-Lineage Lymphoblastic Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
B-Cell Lymphoma
Drug Therapy
Monomethylauristatin F
Follicular Lymphoma Grade 3
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 1 month post last dose
measure: Incidence of laboratory abnormalities
timeFrame: Through 1 month post last dose
Secondary outcomes:
measure: Objective response according to revised response criteria for malignant lymphoma (Cheson 2007)
timeFrame: Through up to approximately 6 week post last dose
measure: Duration of response
timeFrame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
measure: Overall survival
timeFrame: Until death or study closure, an expected average of 1 year
measure: Blood concentration of SGN-CD19A and metabolites
timeFrame: Through up to approximately 6 weeks post last dose
measure: Incidence of antitherapeutic antibodies
timeFrame: Through up to approximately 6 weeks post last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Ana Kostic, MD
role: STUDY_DIRECTOR
References: