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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00474188




Registration number
NCT00474188
Ethics application status
Date submitted
14/05/2007
Date registered
16/05/2007
Date last updated
2/09/2009

Titles & IDs
Public title
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Scientific title
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Secondary ID [1] 0 0
CC-5013-NHL-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 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 - CC-5013 (lenalidomide)
Treatment: Drugs - dexamethasone

Experimental: Single Arm -


Treatment: Drugs: CC-5013 (lenalidomide)
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle

Treatment: Drugs: dexamethasone
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumor Response Rate
Timepoint [1] 0 0
One Year
Secondary outcome [1] 0 0
Tumor Control Rate
Timepoint [1] 0 0
One Year
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
One year
Secondary outcome [3] 0 0
Time to Progression
Timepoint [3] 0 0
One year
Secondary outcome [4] 0 0
Progression-free Survival
Timepoint [4] 0 0
One year

Eligibility
Key inclusion criteria
* Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
* Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
* Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
* ECOG performance score of 0,1 or 2
* Willing to follow the pregnancy precautions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any of the following laboratory abnormalities.
* Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
* Platelet count < 60,000/mm3 (60 x 109/L).
* Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
* Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
* Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
* History of active CNS lymphoma within the previous 3 months
* Subjects not willing or unable to take DVT prophylaxis
* History of other malignancies within the past year
* Positive HIV or active Hepatitis B or C

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Frankston Hospital - Frankston
Recruitment hospital [3] 0 0
HOCA - South Brisbane
Recruitment hospital [4] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
VIC3050 - Melbourne
Recruitment postcode(s) [2] 0 0
VIC 3199 - Frankston
Recruitment postcode(s) [3] 0 0
QLD 4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
VIC 3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
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
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT00474188
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Spencer, MD
Address 0 0
The Alfred
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/NCT00474188