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

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Genentech
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00529503

Purpose

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:

MedlinePlus related topics: Lymphatic Diseases Lymphoma

Drug Information available for: Etoposide Carboplatin Etoposide phosphate Rituximab Dacetuzumab Ifosfamide

U.S. FDA Resources

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 ]

Enrollment:	151
Study Start Date:	September 2007
Study Completion Date:	May 2011
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 SGN-40, rituximab, etoposide, carboplatin, ifosfamide	Drug: SGN-40 2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15. Other Name: dacetuzumab Drug: rituximab 375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1 Other Name: Rituxan Drug: etoposide 100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3. Other Name: Toposar, Vepesid Drug: carboplatin AUC=5 mg/mL min IV. Cycles 1-3: Day 2. Other Name: Paraplatin Drug: ifosfamide 5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2. Other Name: Ifex
Placebo Comparator: 2 placebo, rituximab, etoposide, carboplatin, ifosfamide	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 Other Name: Rituxan Drug: etoposide 100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3. Other Name: Toposar, Vepesid Drug: carboplatin AUC=5 mg/mL min IV. Cycles 1-3: Day 2. Other Name: Paraplatin Drug: ifosfamide 5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2. Other Name: Ifex

Arms

Assigned Interventions

Experimental: 1

SGN-40, rituximab, etoposide, carboplatin, ifosfamide

Drug: SGN-40

2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

Other Name: dacetuzumab

Drug: rituximab

375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1

Other Name: Rituxan

Drug: etoposide

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

Other Name: Toposar, Vepesid

Drug: carboplatin

AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

Other Name: Paraplatin

Drug: ifosfamide

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Other Name: Ifex

Placebo Comparator: 2

placebo, rituximab, etoposide, carboplatin, ifosfamide

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

Other Name: Rituxan

Drug: etoposide

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

Other Name: Toposar, Vepesid

Drug: carboplatin

AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

Other Name: Paraplatin

Drug: ifosfamide

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Other Name: Ifex

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 measureable lesion that is both greater than or equal to 1.5cm 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

Show 66 Study Locations

Sponsors and Collaborators

Seattle Genetics, Inc.

Genentech

Investigators

Study Director:

Jonathan Drachman, MD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00529503 History of Changes
Other Study ID Numbers:	SG040-0005
Study First Received:	September 11, 2007
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Lymphoproliferative Disorders
Lymphoma
Antigens, CD40
Antibody, Monoclonal
Combined Modality Therapy

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

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Etoposide
Etoposide phosphate
Isophosphamide mustard

Rituximab
Ifosfamide
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012