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Trial details imported from ClinicalTrials.gov

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