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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
151
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
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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West Virginia
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Belgium
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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
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France
State/province [27] 0 0
Le Chesnay
Country [28] 0 0
France
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Lyon
Country [29] 0 0
France
State/province [29] 0 0
Nantes
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France
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Paris
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France
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Pessac
Country [32] 0 0
France
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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
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Italy
State/province [45] 0 0
Siena
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Poland
State/province [46] 0 0
Gdansk
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Poland
State/province [47] 0 0
Krakow
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Poland
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Madrid
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Spain
State/province [53] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen 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/study/NCT00529503
Trial related presentations / publications
Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan Drachman, MD
Address 0 0
Seagen 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/study/NCT00529503