Clinical trial · Interventional
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
NCT00227695CI-TRIAL-00038622completedPhase 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 giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Rituximab every 2 months x4
- description
- Rituximab 375 mg/m2 every 2 months x4
- interventionNames
- Biological: rituximab
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Rituximab (5 years)
- description
- Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
- interventionNames
- Biological: rituximab
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- at 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed follicular lymphoma
* Grade 1, 2, 3a, or 3b disease by WHO staging system
* CD20-positive by immunohistochemistry
* Previously untreated disease OR meets 1 of the following criteria for response to prior treatment:
* Chemotherapy-resistant disease
* Relapsed or progressive disease
* Stable disease
* At least 12 weeks since prior systemic treatment
* At least 1 bidimensionally measurable lesion ≥ 11 mm by CT scan or MRI
* No transformation to high-grade lymphoma secondary to low-grade follicular lymphoma
* No prior or current CNS disease (i.e., CNS lymphoma or lymphomatous meningosis) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* Ejection fraction ≥ 50% by echocardiography or MUGA
Immunologic
* No acute or ongoing infection
* No HIV infection
* No active autoimmune disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of the study treatment
* No uncontrolled diabetes mellitus
* No other medical condition that would preclude study participation
* No other malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
* No other condition (e.g., geographic proximity) that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Radiotherapy
* Prior rituximab allowed
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* More than 4 weeks since prior regular administration of corticosteroids
* Dose equivalent to ≤ 20 mg/day prednisone allowed for conditions other than lymphoma or lymphoma-related symptoms
* No concurrent corticosteroids for prevention or treatment of side effects except acute life-threatening side effects
Radiotherapy
* Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy
* At least 12 months since prior anti-CD20 therapy
Surgery
* Not specified
Other
* More than 30 days since prior systemic tumor therapy
* More than 30 days since prior participation in another clinical trial
* No other concurrent anticancer therapyReferences
Publications (5)
- RESULTTaverna CJ, Baasi S, Hitz F, et al.: First results of long-term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. [Abstract] J Clin Oncol 27 (Suppl 15): A-8534, 2009.
- RESULTFirst results of long term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. F. Hitz, S. Bassi, C. Taverna, W. Mingrone, T. Pabst, L. Cevreska, A. Del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini Haematologica (2009) 94: s2; abstract 0413
- RESULTFirst results of long term rituximab maintenance treatment in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. C.J. Taverna, S. Bassi, F. Hitz, W. Mingrone, T. Pabst, L. Cevreska, A. del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini J Clin Oncol (2009) 27: 15s supplement; abstract 8534
- RESULTRituximab maintenance treatment for a maximum of 5 years in follicular lymphoma: safety analysis of the randomized phase III trial SAKK 35/03. C. J. Taverna, S. Bassi, F. Hitz, W. Mingrone, T. Pabst, L. Cevreska, A. del Giglio, D.A. Vorobiof, M. Simcock, M. Ghielmini Blood (2010) 116: ASH Annual Meeting abstracts; abstract 1802
- RESULTTaverna C, Martinelli G, Hitz F, Mingrone W, Pabst T, Cevreska L, Del Giglio A, Vanazzi A, Laszlo D, Raats J, Rauch D, Vorobiof DA, Lohri A, Biaggi Rudolf C, Rondeau S, Rusterholz C, Heijnen IA, Zucca E, Ghielmini M. Rituximab Maintenance for a Maximum of 5 Years After Single-Agent Rituximab Induction in Follicular Lymphoma: Results of the Randomized Controlled Phase III Trial SAKK 35/03. J Clin Oncol. 2016 Feb 10;34(5):495-500. doi: 10.1200/JCO.2015.61.3968. Epub 2015 Dec 28. PMID 26712227