Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

NCT00112931 | Completed Phase 3 DMC

• 4 other identifiers: CDR0000427312CRUK-2004-001621-16EU-20509ROCHE-CRUK-001621-16
• Study Type: interventional
• Target: 462
• Locations: 3 countries
• Sites: 72

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether rituximab is more effective than observation in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma with no symptoms.

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Time until initiation of therapy (chemotherapy or radiotherapy)

  Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy.

Secondary Outcomes (4)

• Frequency of clinical spontaneous remission

  From randomisation until the initiation of chemotherapy in the watch and wait arm

• Cause specific survival

  Time from randomisation to death from lymphoma or immediate therapy related toxicity

• Overall survival

  Time from randomisation to death from any cause.

• Response rate at 25 months

  Response at 25 months

Study Arms (2)

Watch and Wait

ACTIVE COMPARATOR

Watch and Wait - no treatment

Other: No treatment

Arm C Rituximab 4 and Rixuximab Maintenance

EXPERIMENTAL

4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks

Biological: rituximab

Interventions

rituximab BIOLOGICAL

Arm C Rituximab 4 and Rixuximab Maintenance

No treatment OTHER

Watch and Wait

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin's lymphoma * Diagnosed within the past 3 months * Grade 1, 2, or 3a disease * Stage II-IV disease * No evidence of histological transformation * Bidimensionally measurable disease by clinical examination or radiography * Asymptomatic disease without B symptoms or severe pruritus * Low tumor burden, defined by all of the following criteria: * Lactic dehydrogenase normal * Largest nodal or extranodal mass \< 7 cm * No more than 3 nodal sites with a diameter \> 3 cm * No clinically detectable significant serous effusion by chest x-ray * Clinically non-evident small effusion on CT scan is not considered significant * Spleen enlargement ≤ 16 cm by CT scan * Circulating tumor cells \< 5,000/mm\^3 * No organ compression (i.e., ureteric obstruction) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 10 g/dL Hepatic * AST and ALT normal * Alkaline phosphatase normal * Bilirubin normal Renal * Creatinine \< 2 times upper limit of normal (unless due to lymphoma) Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 12 months after completion of rituximab * No known HIV positivity * No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No critical organ failure * No other immediate life-threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for lymphoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead
• Cancer Research UK: collaborator
• Roche Pharma AG: collaborator

Study Sites (72)

Queen Elizabeth Hospital

Adelaide, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Ashford Cancer Centre

Black Forest, Australia

Location

Boxhill Hospital

Box Hill, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Australia

Location

Canberra Hospital

Canberra, Australia

Location

Concord Repatriation General Hospital

Concord, Australia

Location

Frankston Hospital

Frankston, Australia

Location

Fremantle Hospital

Fremantle, Australia

Location

Gosford Hospital

Gosford, Australia

Location

Royal Hobart Hospital

Hobart, Australia

Location

Nepean Hospital

Kingswood, Australia

Location

Lismore Base Hospital

Lismore, Australia

Location

Liverpool Hospital

Liverpool, Australia

Location

Alfred Hospital

Melbourne, Australia

Location

Austin Health

Melbourne, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Australia

Location

St Vincent's Hospital

Melbourne, Australia

Location

Mater Misericordiae Hospital

Newcastle, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Royal North Shore Hospital

St Leonards, Australia

Location

St Vincent's Hospital

Sydney, Australia

Location

Westmead Hospital

Westmead, Australia

Location

Murray Valley Private Hospital

Wodonga, Australia

Location

Wollongong Hospital

Wollongong, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

Auckland Hospital

Auckland, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

North Shore Hospital

Westlake, New Zealand

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

West Suffolk Hospital

Bury St Edmunds, England, IP33 2QZ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

St. Helier Hospital

Carshalton, England, SM5 1AA, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Medway Maritime Hospital

Gillingham, England, ME7 5NY, United Kingdom

Location

Hemel Hempstead General

Hemel Hempstead, England, HP2 4AD, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

West Middlesex University Hospital

Isleworth, England, TW7 6AF, United Kingdom

Location

Kettering General Hosptial

Kettering, England, NNI6 8UZ, United Kingdom

Location

Kidderminster Hospital

Kidderminster, England, DY11 6RJ, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, England, B98 7UB, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Pembury Hospital

Royal Tunbridge Wells, England, TN2 4QJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, England, TR1 3LJ, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Monklands General Hospital

Airdrie, Scotland, ML6 0JF, United Kingdom

Location

Hairmyres Hospital

East Kilbride, Scotland, G75 8RG, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Southern General Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Prince Charles Hospital

Merthyr Tydfil, Wales, CF47 9DT, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Wales, LL 18 5UJ, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (2)

• Northend M, Wilson W, Ediriwickrema K, Clifton-Hadley L, Qian W, Rana Z, Martin TL, Townsend W, Young M, Miall F, Cunningham D, Walewski J, Ferhanoglu B, Linton K, Johnston A, Seymour JF, Linch DC, Ardeshna KM. Early rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumour burden follicular lymphoma: long-term results of a randomised, phase 3 trial. Lancet Haematol. 2025 May;12(5):e335-e345. doi: 10.1016/S2352-3026(25)00034-1.

  PMID: 40306831 DERIVED

• Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, Warden J, Stevens L, Pocock CF, Miall F, Cunningham D, Davies J, Jack A, Stephens R, Walewski J, Ferhanoglu B, Bradstock K, Linch DC. Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014 Apr;15(4):424-35. doi: 10.1016/S1470-2045(14)70027-0. Epub 2014 Mar 4.

  PMID: 24602760 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kirit Ardeshna

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: September 1, 2004
• Primary Completion: March 1, 2014
• Study Completion: September 14, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

GB (42); NZ (4); AU (26)