Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma - Full Text View

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003280

Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which treatment regimen is more effective for lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	240
Study Start Date:	January 1998

Detailed Description:

OBJECTIVES:

Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell lymphoma.
Compare the event free survival of patients after induction with or without consolidation.
Compare the tolerability of these two treatment regimens by these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to participating center, histology (follicular (closed to accrual 9/18/00) vs mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction (stable disease vs partial or complete response), and treatment status (treated vs untreated).

All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4. Patients are then randomized to one of two treatment arms.

Arm I: Patients are observed.
Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20, 28, and 36.

Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then at 12, 18, and 24 months; and then annually for the next 3 years.

PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 3-4 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle cell lymphoma
- Untreated "de novo" disease OR
- Chemotherapy resistant disease OR
- Relapsing disease
Bidimensionally measurable disease
No symptomatic CNS disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

At least 3 months

Hematopoietic:

Not specified

Hepatic:

Bilirubin no greater than 2 times upper limit of normal (ULN)
No hepatitis B or C

Renal:

Creatinine no greater than 2 times ULN

Cardiovascular:

Ejection fraction at least 50%

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No active opportunistic infections
HIV negative
No prior malignancy within 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior antibody based therapy

Chemotherapy:

At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas) and recovered
No concurrent chemotherapy

Endocrine therapy:

At least 4 weeks since prior corticosteroids, unless chronic dose no greater than 20 mg/day for nonlymphoma related condition
No other concurrent corticosteroids

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003280

Locations

Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
University Hospital
Basel, Switzerland, CH-4031
Office of Walter Weber-Stadelman
Basel, Switzerland, CH 4051
Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital, Bern
Bern, Switzerland, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland, CH-6900
Burgerspital, Solothurn
Solothurn, Switzerland, 4500
City Hospital Triemli
Zurich, Switzerland, 8063
Klinik Hirslanden
Zurich, Switzerland, CH-8008

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:

Michele Ghielmini, MD

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

More Information

Publications:

Martinelli G, Hsu Schmitz SF, Utiger U, Cerny T, Hess U, Bassi S, Okkinga E, Stupp R, Stahel R, Heizmann M, Vorobiof D, Lohri A, Dietrich PY, Zucca E, Ghielmini M. Long-Term Follow-Up of Patients With Follicular Lymphoma Receiving Single-Agent Rituximab at Two Different Schedules in Trial SAKK 35/98. J Clin Oncol. 2010 Aug 9; [Epub ahead of print]

Ghielmini ME, Hsu Schmitz S, Martinelli G, et al.: Long-term follow-up of patients with follicular lymphoma (FL) receiving single agent rituximab at two different schedules in study SAKK 35/98. [Abstract] J Clin Oncol 27 (Suppl15): A-8512, 2009.

Ghielmini M, Rufibach K, Salles G, Leoncini-Franscini L, Leger-Falandry C, Cogliatti S, Fey M, Martinelli G, Stahel R, Lohri A, Ketterer N, Wernli M, Cerny T, Schmitz SF. Single agent rituximab in patients with follicular or mantle cell lymphoma: clinical and biological factors that are predictive of response and event-free survival as well as the effect of rituximab on the immune system: a study of the Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol. 2005 Oct;16(10):1675-82. Epub 2005 Jul 19.

Ghielmini M, Schmitz SF, Cogliatti S, Bertoni F, Waltzer U, Fey MF, Betticher DC, Schefer H, Pichert G, Stahel R, Ketterer N, Bargetzi M, Cerny T; Swiss Group for Clinical Cancer Research. Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol. 2005 Feb 1;23(4):705-11. Epub 2004 Dec 14.

ClinicalTrials.gov Identifier:	NCT00003280 History of Changes
Other Study ID Numbers:	CDR0000066188, SWS-SAKK-35/98, ICR-35/98, EU-98009
Study First Received:	November 1, 1999
Last Updated:	August 6, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma

stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012