Clinical trial NCT01786096: A Safety Study of SGN-CD19A for Leukemia and Lymphoma
Official title: A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burkitt Lymphoma
Precursor B-cell Lymphoblastic Leukemia-Lymphoma
Keywords: Burkitt Lymphoma
Antibodies, Monoclonal
Antibody-Drug Conjugate
B-Lineage Acute Lymphoblastic Leukemia
B-Lineage Lymphoblastic Lymphoma
Burkitt Leukemia
Monomethylauristatin F
Antigens, CD19
Drug Therapy
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 92
Sex: ALL
Minimum age (years): 1
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 adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).


Eligibility criteria: Inclusion Criteria:

* Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
* Eastern Cooperative Oncology Group status of 2 or lower
* Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
* Measurable disease

Exclusion Criteria:

* Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)
timeFrame: Through 1 month post last dose
measure: Duration of response
timeFrame: Until disease progression or start of new anticancer treatment, an expected average of 3 months
measure: Overall survival
timeFrame: Until death or study closure, an expected average of 6 months
measure: Blood concentrations of SGN-CD19A and metabolites
timeFrame: Cycles 1, 2, and 4: predose, 30 minutes, and up to 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
measure: Incidence of antitherapeutic antibodies
timeFrame: Predose in most cycles and 1 month post last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama / University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta / Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Seagen Inc.
name: Eric Feldman, MD
role: STUDY_DIRECTOR
References: