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A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

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Trial Information

A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)


Inclusion Criteria:



- Have a histologic diagnosis of DLBCL, including transformed histology and follicular
grade 3 disease.

- Must have at least one site of biopsy-proven disease demonstrating both of the
following: bidimensional measurable disease with the longest axis >= 1.5cm by
radiographic imaging or positive FDG-PET scan at baseline.

- Patients with DLBCL and who have either relapsed, refractory, or progressive disease
following salvage therapy, OR relapsed, refractory, or progressive disease following
initial therapy and be medically unfit to receive aggressive therapy.

- Either fresh or archived tumor specimen must be available.

Exclusion Criteria:

- Documented history within 6 months of registration of a cerebral vascular event,
unstable angina, myocardial infarction, or cardiac symptoms.

- Patients who have received allogeneic stem cell transplant.

- Patients with evidence of another invasive primary malignancy within the past three
years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ
carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8
weeks of registration.

- Patients with any active systemic viral, bacterial, or fungal infection requiring
intravenous anti-infectives within 4 weeks prior to first dose of study drug.

- Patients with a history or clinical evidence of leptomeningeal or central nervous
system (CNS) lymphoma.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab.

Outcome Time Frame:

10 months from registration of last patient

Safety Issue:

Yes

Principal Investigator

Nancy Whiting, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG040-0008

NCT ID:

NCT00655837

Start Date:

April 2008

Completion Date:

February 2010

Related Keywords:

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Antigens, CD40
  • Antibodies, Monoclonal
  • Combined Modality Therapy
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Hematologic Diseases
  • Immunoproliferative Disorders
  • Lymphatic Diseases
  • Lymphoproliferative Disorders
  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
University of ColoradoDenver, Colorado  80217
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Nevada Cancer InstituteLas Vegas, Nevada  89135
Mayo Clinic ArizonaScottsdale, Arizona  85259
Oncology SpecialistsPark Ridge, Illinois  60068