NCT00641095 (MCLPIII) is a Phase 2, PHASE3 clinical trial of rituximab in Lymphoma, sponsored by University College, London.

Who is sponsoring NCT00641095?

NCT00641095 is sponsored by University College, London.

What drugs are being tested in NCT00641095?

Interventions in NCT00641095: rituximab, Cyclophosphamide, Fludarabine.

Is NCT00641095 still recruiting?

NCT00641095 is currently completed. Last updated 31 October 2018.

Last reviewed 2018-10-31 · How we verify

NCT00641095: MCLPIII

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Last updated 31 October 2018

What this trial tests

Phase 2, PHASE3 trial testing rituximab in Lymphoma in 370 participants. Completed in 22 May 2015.

Timeline

7 December 2006

Primary endpoint
23 November 2011

22 May 2015

Quick facts

Lead sponsor	University College, London
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	370
Start date	7 December 2006
Primary completion	23 November 2011
Estimated completion	22 May 2015
Sites	67 locations across United Kingdom, Australia

Drugs / interventions tested

rituximab — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →

Conditions studied

Lymphoma — all drugs for Lymphoma →

Sponsor

University College, London

Who can join

Adults 18 to 120, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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.
Rule S, Smith P, Johnson PW, Bolam S, et al · · 2016 · cited 21× · PMID 26611473 · DOI 10.3324/haematol.2015.128710

Verify or expand the search:

Other trials of rituximab

Trials testing the same drug.

NCT06015750 — Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia · Phase 4 · withdrawn
NCT07073833 — The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed/Refractory B-cell Non Hodgkin Lymphoma · Phase 1 · recruiting
NCT06700798 — Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial · Phase 2 · recruiting
NCT06655896 — Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis · Phase 2 · recruiting
NCT07041268 — Immunotherapy of the Recent-onset Type 1 Diabetes in Adolescents With Repeated Courses of Rituximab · Phase 2 · recruiting

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07226934 — An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers · NA · recruiting
NCT07138547 — GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma · Phase 1, PHASE2 · recruiting

Other University College, London trials

Trials by the same sponsor.

NCT07386652 — Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia · NA · not yet recruiting
NCT06924086 — The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial · NA · recruiting
NCT07386678 — Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment · not yet recruiting
NCT07414940 — ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium · Phase 1, PHASE2 · not yet recruiting
NCT07214454 — TCDS for the Treatment of Chronic Migraine · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00641095 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University College, London
Last refreshed: 31 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00641095.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing