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A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma


Phase 1
12 Years
N/A
Open (Enrolling)
Both
Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, 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 Relapsed or Refractory B-Lineage Non-Hodgkin Lymphoma


Inclusion Criteria:



- Pathologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma Grade
3, diffuse large B-cell lymphoma (DLBCL), 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)

- Previous treatment with anti-CD19 directed therapy

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

Ana Kostic, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN19A-002

NCT ID:

NCT01786135

Start Date:

February 2013

Completion Date:

December 2016

Related Keywords:

  • Burkitt Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-cell
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • 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
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Stanford Cancer Center Stanford, California  94305-5824
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
MD Anderson Cancer Center /The University of Texas Houston, Texas  77030