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A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas


Phase 1
1 Year
N/A
Open (Enrolling)
Both
Burkitt Lymphoma, Precursor B-cell Lymphoblastic Leukemia-Lymphoma

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Trial Information

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events

Outcome Time Frame:

Through 1 month post last dose

Safety Issue:

Yes

Principal Investigator

Tina Albertson, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN19A-001

NCT ID:

NCT01786096

Start Date:

February 2013

Completion Date:

June 2016

Related Keywords:

  • Burkitt Lymphoma
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Burkitt Lymphoma
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • B-Lineage Acute Lymphoblastic Leukemia
  • B-Lineage Lymphoblastic Lymphoma
  • Burkitt Leukemia
  • Monomethylauristatin F
  • Antigens, CD19
  • Drug Therapy
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
City of Hope Duarte, California  91010
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Boston Children's Hospital Boston, Massachusetts  02115
Children's Healthcare of Atlanta / Emory University Atlanta, Georgia  30322