Lymphoma Clinical Trial
Official title:
Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated, Chemotherapy Resistant or Relapsed Follicular Lymphoma: A Randomized Phase III Trial
Verified date | May 2019 |
Source | Swiss Group for Clinical Cancer Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 270 |
Est. completion date | December 19, 2017 |
Est. primary completion date | May 3, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Clinical Center - Institute of Hematology | Sao Paulo | |
Italy | Istituto Europeo di Oncologia IEO | Milano | |
North Macedonia | Clinical Center Skopje | Skopje | |
Serbia | Clinical Center of Serbia | Belgrade | |
Slovakia | NOU - National Institute for Oncology | Bratislava | |
South Africa | Panorama Medical Centre | Cape Town | |
South Africa | Sandton Oncology Centre | Johannesburg | |
Switzerland | Kantonspital Aarau | Aarau | |
Switzerland | Kantonsspital Baden | Baden | |
Switzerland | St. Claraspital AG | Basel | |
Switzerland | Universitaetsspital Basel | Basel | |
Switzerland | Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli | Bellinzona | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Breitenbach Praxis Dr. Haberthür | Breitenbach | |
Switzerland | Kantonsspital Bruderholz | Bruderholz | |
Switzerland | Kantonsspital Graubuenden | Chur | |
Switzerland | Hopital Cantonal Universitaire de Geneve | Geneva | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | Kantonsspital | Liestal | |
Switzerland | Istituto Oncologico della Svizzera Italiana | Lugano | |
Switzerland | Hôpital Pourtalès | Neuchâtel | |
Switzerland | Kantonsspital - St. Gallen | St. Gallen | |
Switzerland | SpitalSTS AG Simmental-Thun-Saanenland | Thun | |
Switzerland | City Hospital Triemli | Zurich | |
Switzerland | Klinik Hirslanden | Zurich | |
Switzerland | UniversitaetsSpital Zuerich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Swiss Group for Clinical Cancer Research |
Brazil, Italy, North Macedonia, Serbia, Slovakia, South Africa, Switzerland,
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,
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
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,
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 — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival | at 10 years | ||
Secondary | Progression-free survival | at 10 years | ||
Secondary | Overall survival | at 10 years | ||
Secondary | Adverse reactions during and after maintenance treatment | 10 years |
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