Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

Sponsor
University College, London
Study ID
NCT00641095
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    concentrate for solution for infusion
  • Cyclophosphamide — DRUG
    Tablets
  • Fludarabine — DRUG
    Film coated tablet

Study Details

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.

Key Dates

Start date
Dec 7, 2006
Status verified
Oct 2018
Primary completion
Nov 23, 2011
Completion
May 22, 2015

Study Design

Enrollment
370 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Overall survival [ Time Frame: From date of first administration of treatment until the date of death from any cause, assessed up to a maximum of 60 months ]

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