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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00053092




Registration number
NCT00053092
Ethics application status
Date submitted
27/01/2003
Date registered
28/01/2003
Date last updated
18/12/2013

Titles & IDs
Public title
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Scientific title
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Secondary ID [1] 0 0
NCRI-LY05
Secondary ID [2] 0 0
CDR0000269136
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Other interventions - rituximab
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - fludarabine phosphate

Other interventions: rituximab


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: fludarabine phosphate
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rate
Timepoint [1] 0 0
Primary outcome [2] 0 0
Time to disease progression
Timepoint [2] 0 0
Primary outcome [3] 0 0
Toxicity
Timepoint [3] 0 0
Primary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed previously untreated mantle cell lymphoma requiring therapy

- Any stage

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- At least 3 months

Hematopoietic

- Not specified

Hepatic

- Bilirubin no greater than 2.5 times upper limit of normal (ULN)^*

- Alkaline phosphatase no greater than 2.5 times ULN^*

- Hepatitis B and hepatitis C negative NOTE: *Unless related to lymphoma

Renal

- Creatinine no greater than 2.5 times ULN^* NOTE: *Unless related to lymphoma

Other

- No other malignancy within the past 5 years except non-melanoma skin cancer or
curatively resected carcinoma in situ of the cervix

- No prior psychological illness or condition that would preclude study compliance

- No known hypersensitivity to murine proteins

- No concurrent uncontrolled medical conditions

- No other illness that would severely limit life expectancy

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Institute of Cancer Research, United Kingdom
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Leukaemia and Lymphoma Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
and either kill them or deliver cancer-killing substances to them without harming normal
cells. It is not yet known if combination chemotherapy is more effective with or without
rituximab in treating mantle cell lymphoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and
cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in
treating patients who have mantle cell lymphoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00053092
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Simon Rule, MD
Address 0 0
Derriford Hospital
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/ct2/show/NCT00053092