A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Leukemia/MDS, Pediatric Leukemia, Pediatric Lymphoma
NCT ID: NCT01786096 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-461


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).


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Amir Fathi, M.D., Massachusetts General Hospital

Site-responsible Investigators:
Lewis Silverman, MD, Dana-Farber Cancer Institute
Daniel DeAngelo, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

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: - Previous treatment with anti-CD19 directed therapy - Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD
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