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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00641095




Registration number
NCT00641095
Ethics application status
Date submitted
20/03/2008
Date registered
21/03/2008
Date last updated
31/10/2018

Titles & IDs
Public title
Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Scientific title
Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Secondary ID [1] 0 0
2006-001965-41
Secondary ID [2] 0 0
UCL/06/052
Universal Trial Number (UTN)
Trial acronym
MCLPIII
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
Treatment: Other - rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine

Experimental: Fludarabine/Cyclophosphamide/Rituximab - Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion

Every 28 days

Active comparator: Fludarabine/Cyclophosphamide - Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3

Every 28 days


Treatment: Other: rituximab
concentrate for solution for infusion

Treatment: Drugs: Cyclophosphamide
Tablets

Treatment: Drugs: Fludarabine
Film coated tablet
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
From date of first administration of treatment until the date of death from any cause, assessed up to a maximum of 60 months
Secondary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
From date of first treatment administration until the date of first documented progression or relapse, whichever came first, assessed up to a maximum of 60 months
Secondary outcome [2] 0 0
Toxicity - Number of patients with >=grade 3 toxicity
Timepoint [2] 0 0
Within 30 days after last dose of treatment
Secondary outcome [3] 0 0
Toxicity - Percentage of patients with >=grade 3 toxicity
Timepoint [3] 0 0
Within 30 days after last dose of treatment
Secondary outcome [4] 0 0
Tumor response duration
Timepoint [4] 0 0
From date of first documentation of PR or CR until the date of first progression up to a maximum of 60 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed mantle cell lymphoma (MCL), meeting the following criteria:

* Diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential
* Central review of histology will be performed on diagnostic material
* Molecular or cytogenetic confirmation of diagnosis is not required
* Previously untreated disease at any stage requiring therapy in the opinion of the treating physician

PATIENT CHARACTERISTICS:

* Life expectancy = 3 months

* Life expectancy not severely limited by other illness
* Creatinine clearance = 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study therapy
* No known serological positivity for HBV, HCV, or HIV
* No concurrent uncontrolled serious medical conditions
* No severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma
* No known hypersensitivity to murine proteins
* No prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix
* No history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
Minimum age
18 Years
Maximum age
120 Years
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
Parallel
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
7/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/05/2015
Sample size
Target
Accrual to date
Final
370
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
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Scotland
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Wales
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Amersham
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research UK
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT00641095
Trial related presentations / publications
Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. doi: 10.3324/haematol.2015.128710. Epub 2015 Nov 26.
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/study/NCT00641095