A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL - Full Text View

Sponsors and Collaborators:	Seattle Genetics, Inc. Genentech
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00529503

Purpose

This is a phase IIb, placebo-controlled randomized trial to estimate the activity of R-ICE in combination with SGN-40 vs. R-ICE in combination with placebo in patients with DLBCL. The study will also assess safety and tolerability of the combined therapy and will measure any additional clinical benefit observed in patients receiving SGN-40.

Condition	Intervention	Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin	Drug: SGN-40 Drug: placebo Drug: rituximab Drug: etoposide Drug: carboplatin Drug: ifosfamide	Phase II

MedlinePlus related topics: Lymphatic Diseases Lymphoma

Drug Information available for: Ifosfamide Carboplatin Etoposide Rituximab Etoposide phosphate Immunoglobulins Globulin, Immune Dacetuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-Line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, laboratory values, and anti-drug antibody immune responses. [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
Partial response, failure free survival, overall survival, and response for one and two years following treatment. [ Time Frame: Every 3 months for 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	224
Study Start Date:	September 2007
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SGN-40 2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15. Drug: rituximab 375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1 Drug: etoposide 100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3. Drug: carboplatin AUC=5 mg/mL min IV. Cycles 1-3: Day 2. Drug: ifosfamide 5 g/m2 24 hr. IV infusion. Cycles 1-3: Day 2.
2: Placebo Comparator	Drug: placebo Volume as equivalent to corresponding SGN 40 dose. IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15. Drug: rituximab 375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1 Drug: etoposide 100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3. Drug: carboplatin AUC=5 mg/mL min IV. Cycles 1-3: Day 2. Drug: ifosfamide 5 g/m2 24 hr. IV infusion. Cycles 1-3: Day 2.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.
Received at least four cycles of first-line therapy with R-CHOP, or equivalent.
Best clinical response to first-line therapy of stable disease, partial response, or complete response.
At least one measurable lesion that is both greater than or equal to1.5 cm by radiographic imaging and by positive FDG-PET scan.

Exclusion Criteria:

Leptomeningeal or central nervous system lymphoma.
Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.
Received a hematopoietic stem cell transplant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529503

Contacts

Contact: Terri Lowe

866.333.7436

clinicaltrials@seagen.com

Show 69 Study Locations

Sponsors and Collaborators

Seattle Genetics, Inc.

Genentech

Investigators

Study Director:

Jonathan G Drachman, MD

Seattle Genetics, Inc.

More Information

Responsible Party:	Seattle Genetics ( Jonathan G Drachman, MD )
Study ID Numbers:	SG040-0005
Study First Received:	September 11, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00529503
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD40
Antibody, Monoclonal
Combined Modality Therapy
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin

Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Rituximab
Carboplatin
Etoposide phosphate
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, large-cell
Lymphatic Diseases

Antibodies
Ifosfamide
Mechlorethamine
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma
Immunoglobulins
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Neoplasms
Therapeutic Uses
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009