Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

NCT00655837 | Completed Phase 1

• 1 other identifier: SG040-0008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  10 months from registration of last patient

Secondary Outcomes (1)

• Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy.

  Follow-up every 6 weeks after end of treatment.

Study Arms (1)

1

EXPERIMENTAL

Drug: SGN-40; Drug: rituximab; Drug: gemcitabine

Interventions

SGN-40 DRUG

4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.

Also known as: dacetuzumab

1

rituximab DRUG

375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.

Also known as: Rituxan

1

gemcitabine DRUG

1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.

Also known as: Gemzar

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen Inc.: lead
• Genentech, Inc.: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

University of Colorado

Aurora, Colorado, 80045-0510, United States

Location

Oncology Specialists

Park Ridge, Illinois, 60068, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Forero-Torres A, Bartlett N, Beaven A, Myint H, Nasta S, Northfelt DW, Whiting NC, Drachman JG, Lobuglio AF, Moskowitz CH. Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2013 Feb;54(2):277-83. doi: 10.3109/10428194.2012.710328. Epub 2012 Sep 8.

  PMID: 22775314 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Hematologic Diseases; Immunoproliferative Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Lymphoma

Interventions

dacetuzumab; Rituximab; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nancy Whiting, PharmD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (9)