Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma

NCT00227695 | Completed Phase 3

• 4 other identifiers: SAKK 35/03SWS-SAKK-35/03EU-20520CDR0000443594
• Study Type: interventional
• Target: 270
• Locations: 7 countries
• Sites: 26

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 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

Lymphoma

Keywords

stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; 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; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II 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; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  at 10 years

Secondary Outcomes (3)

• Progression-free survival

  at 10 years

• Overall survival

  at 10 years

• Adverse reactions during and after maintenance treatment

  10 years

Study Arms (2)

Arm A: Rituximab every 2 months x4

ACTIVE COMPARATOR

Rituximab 375 mg/m2 every 2 months x4

Biological: rituximab

Arm B: Rituximab (5 years)

ACTIVE COMPARATOR

Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity

Biological: rituximab

Interventions

rituximab BIOLOGICAL

comparing two maintenance schedules of Rituximab

Also known as: MABTHERA

Arm A: Rituximab every 2 months x4; Arm B: Rituximab (5 years)

Eligibility Criteria

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

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 therapy

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (26)

Clinical Center - Institute of Hematology

São Paulo, Brazil

Location

Istituto Europeo di Oncologia IEO

Milan, 20141, Italy

Location

Clinical Center Skopje

Skopje, 1000, North Macedonia

Location

Clinical Center of Serbia

Belgrade, SCG-11000, Serbia

Location

NOU - National Institute for Oncology

Bratislava, 83310, Slovakia

Location

Panorama Medical Centre

Cape Town, 7500, South Africa

Location

Sandton Oncology Centre

Johannesburg, 2121, South Africa

Location

Kantonspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

St. Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Breitenbach Praxis Dr. Haberthür

Breitenbach, 4226, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital

Liestal, CH-4410, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Hôpital Pourtalès

Neuchâtel, 2002, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

SpitalSTS AG Simmental-Thun-Saanenland

Thun, 3600, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (5)

• Taverna 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.

  RESULT

• First 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

  RESULT

• First 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

  RESULT

• Rituximab 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

  RESULT

• Taverna 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 RESULT

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

• Christian Taverna, MD

  Kantonsspital Münsterlingen

  STUDY CHAIR

• Michele Ghielmini, Prof.

  IOSI - Ospedale San Giovanni, Bellinzona

  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: September 26, 2005
• First Posted: September 28, 2005
• Study Start: June 8, 2004
• Primary Completion: May 3, 2013
• Study Completion: December 19, 2017
• Last Updated: May 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); NO (1); SE (1); SL (1); IT (1); ZA (2); CH (19)