A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Burkitt Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786096
• Other study ID #: SGN19A-001
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2013
• Last updated: June 29, 2017
• Start date: February 2013
• Est. completion date: May 30, 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• SGN-CD19A
SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta / Emory University	Atlanta	Georgia
United States	Children's Hospital of Alabama / University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Mayo Clinic Arizona	Scottsdale	Arizona
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 modified response criteria for acute myeloid leukemia (Cheson 2003) or revised response criteria for malignant lymphoma (Cheson 2007)		Through 1 month post last dose
Secondary	Duration of response		Until disease progression or start of new anticancer treatment, an expected average of 3 months
Secondary	Overall survival		Until death or study closure, an expected average of 6 months
Secondary	Blood concentrations of SGN-CD19A and metabolites		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
Secondary	Incidence of antitherapeutic antibodies		Predose in most cycles and 1 month post last dose