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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00529503




Registration number
NCT00529503
Ethics application status
Date submitted
11/09/2007
Date registered
14/09/2007
Date last updated
25/02/2015

Titles & IDs
Public title
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
Scientific 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)
Secondary ID [1] 0 0
SG040-0005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Large B-Cell, Diffuse 0 0
Lymphoma, Non-Hodgkin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SGN-40
Treatment: Drugs - placebo
Treatment: Drugs - rituximab
Treatment: Drugs - etoposide
Treatment: Drugs - carboplatin
Treatment: Drugs - ifosfamide

Experimental: 1 - SGN-40, rituximab, etoposide, carboplatin, ifosfamide

Placebo Comparator: 2 - placebo, rituximab, etoposide, carboplatin, ifosfamide


Treatment: Drugs: SGN-40
2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

Treatment: Drugs: placebo
Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.

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

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

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Timepoint [1] 0 0
9 weeks
Secondary outcome [1] 0 0
Adverse events, laboratory values, and anti-drug antibody immune responses.
Timepoint [1] 0 0
9 weeks
Secondary outcome [2] 0 0
Partial response, failure free survival, overall survival, and response for one and two years following treatment.
Timepoint [2] 0 0
Every 3 months for 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Gosford & Wyong Hospital - Gosford
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
The Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
St. Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Wilrijk
Country [23] 0 0
Belgium
State/province [23] 0 0
Yvoir
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Praha 2
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Praha 5
Country [27] 0 0
France
State/province [27] 0 0
Le Chesnay
Country [28] 0 0
France
State/province [28] 0 0
Lyon
Country [29] 0 0
France
State/province [29] 0 0
Nantes
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Pessac
Country [32] 0 0
France
State/province [32] 0 0
Pierre Benite
Country [33] 0 0
France
State/province [33] 0 0
Rouen
Country [34] 0 0
France
State/province [34] 0 0
Toulouse
Country [35] 0 0
France
State/province [35] 0 0
Villejuif
Country [36] 0 0
Germany
State/province [36] 0 0
Mainz
Country [37] 0 0
Germany
State/province [37] 0 0
Monchengladbach
Country [38] 0 0
Germany
State/province [38] 0 0
Ulm
Country [39] 0 0
Hungary
State/province [39] 0 0
Debrecen
Country [40] 0 0
Hungary
State/province [40] 0 0
Gyor
Country [41] 0 0
Hungary
State/province [41] 0 0
Kaposvar
Country [42] 0 0
Hungary
State/province [42] 0 0
Szeged
Country [43] 0 0
Italy
State/province [43] 0 0
Florence
Country [44] 0 0
Italy
State/province [44] 0 0
Genova
Country [45] 0 0
Italy
State/province [45] 0 0
Siena
Country [46] 0 0
Poland
State/province [46] 0 0
Gdansk
Country [47] 0 0
Poland
State/province [47] 0 0
Krakow
Country [48] 0 0
Poland
State/province [48] 0 0
Lodz
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Poland
State/province [50] 0 0
Wroclaw
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seattle Genetics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00529503
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan Drachman, MD
Address 0 0
Seattle Genetics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00529503