Clinical trial · Interventional
Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
NCT00112931CI-TRIAL-00076946completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No treatment | Other | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Watch and Wait
- description
- Watch and Wait - no treatment
- interventionNames
- Other: No treatment
- type
- EXPERIMENTAL
- label
- Arm C Rituximab 4 and Rixuximab Maintenance
- description
- 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
- interventionNames
- Biological: rituximab
Primary outcomes (1)
- measure
- Time until initiation of therapy (chemotherapy or radiotherapy)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 lymphomaReferences
Publications (2)
- DERIVEDNorthend 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
- DERIVEDArdeshna 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