Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Swiss Group for Clinical Cancer Research
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00227695
First received: September 26, 2005
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Swiss Group for Clinical Cancer Research:
Primary Outcome Measures:
- Event-free survival [ Time Frame: at 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: at 10 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: at 10 years ] [ Designated as safety issue: No ]
- Adverse reactions during and after maintenance treatment [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 270 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm A: Rituximab every 2 months x4
Rituximab 375 mg/m2 every 2 months x4
|
Biological: rituximab
comparing two maintenance schedules of Rituximab
Other Name: MABTHERA
|
|
Active Comparator: Arm B: Rituximab (5 years)
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
|
Biological: rituximab
comparing two maintenance schedules of Rituximab
Other Name: MABTHERA
|
Detailed Description:
OBJECTIVES:
Primary
- Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with follicular non-Hodgkin's lymphoma.
Secondary
- Compare the safety of these regimens in these patients.
- Compare the pharmaeconomical aspects of these regimens in these patients.
- Compare the evolution of immunologic competence in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study.
- Induction therapy: Patients receive rituximab IV weekly in weeks 1-4 and undergo restaging between weeks 11-13. Patients with stable disease or progressive disease are taken off study. Patients achieving partial or complete response are stratified according to prior treatment status (untreated* vs treated with or without anti-CD20 therapy), presence of bulky disease** at study entry (yes vs no), and participating center. Patients are then randomized to 1 of 2 maintenance treatment arms.
NOTE: *Patients treated with radiotherapy only are considered as therapy-naïve.
NOTE: **Defined as a mass or lymph node conglomerate ≥ 5 cm diameter.
Maintenance therapy: Patients start maintenance therapy within 7 days of randomization.
- Arm I: Patients receive rituximab IV every 2 months for 4 treatments.
- Arm II: Patients receive rituximab IV every 2 months for up to 5 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization.
PROJECTED ACCRUAL: A total of 270 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227695
Locations
| Brazil | |
| Clinical Center - Institute of Hematology | |
| Sao Paulo, Brazil | |
| Italy | |
| Istituto Europeo di Oncologia IEO | |
| Milano, Italy, 20141 | |
| Macedonia, The Former Yugoslav Republic of | |
| Clinical Center Skopje | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Serbia | |
| Clinical Center of Serbia | |
| Belgrade, Serbia, SCG-11000 | |
| Slovakia | |
| NOU - National Institute for Oncology | |
| Bratislava, Slovakia, 83310 | |
| South Africa | |
| Panorama Medical Centre | |
| Cape Town, South Africa, 7500 | |
| Sandton Oncology Centre | |
| Johannesburg, South Africa, 2121 | |
| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, CH-5001 | |
| Kantonsspital Baden | |
| Baden, Switzerland, CH-5404 | |
| Universitaetsspital Basel | |
| Basel, Switzerland, CH-4031 | |
| St. Claraspital AG | |
| Basel, Switzerland, CH-4016 | |
| Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli | |
| Bellinzona, Switzerland, 6500 | |
| Inselspital Bern | |
| Bern, Switzerland, 3010 | |
| Breitenbach Praxis Dr. Haberthür | |
| Breitenbach, Switzerland, 4226 | |
| Kantonsspital Bruderholz | |
| Bruderholz, Switzerland, CH-4101 | |
| Kantonsspital Graubuenden | |
| Chur, Switzerland, CH-7000 | |
| Hopital Cantonal Universitaire de Geneve | |
| Geneva, Switzerland, CH-1211 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| Kantonsspital | |
| Liestal, Switzerland, CH-4410 | |
| Istituto Oncologico della Svizzera Italiana | |
| Lugano, Switzerland, CH-6900 | |
| Hôpital Pourtalès | |
| Neuchâtel, Switzerland, 2002 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| SpitalSTS AG Simmental-Thun-Saanenland | |
| Thun, Switzerland, 3600 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| UniversitaetsSpital Zuerich | |
| Zurich, Switzerland, CH-8091 | |
| Klinik Hirslanden | |
| Zurich, Switzerland, CH-8032 | |
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
| Study Chair: | Christian Taverna, MD | Kantonsspital Münsterlingen |
| Study Chair: | Michele Ghielmini, Prof. | IOSI - Ospedale San Giovanni, Bellinzona |
More Information
Publications:
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.
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00227695 History of Changes |
| Other Study ID Numbers: | SAKK 35/03, SWS-SAKK-35/03, EU-20520, CDR0000443594 |
| Study First Received: | September 26, 2005 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Swiss Group for Clinical Cancer Research:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013