Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003280
• Other study ID #: SAKK 35/98
• Secondary ID: SWS-SAKK-35/98IC
• Status: Completed
• Phase: Phase 3
• Start date: January 1998
• Est. completion date: March 2002

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Biological:
• rituximab

Locations

Country	Name	City	State
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Office of Walter Weber-Stadelman	Basel
Switzerland	University Hospital	Basel
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Inselspital, Bern	Bern
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
Switzerland	Istituto Oncologico della Svizzera Italiana	Lugano
Switzerland	Burgerspital, Solothurn	Solothurn
Switzerland	City Hospital Triemli	Zurich
Switzerland	Klinik Hirslanden	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Ghielmini M, Rufibach K, Salles G, Leoncini-Franscini L, Léger-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 — View Citation

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 — View Citation

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.

Lee CS, Ashton-Key M, Cogliatti S, Rondeau S, Schmitz SF, Ghielmini M, Cragg MS, Johnson P. Expression of the inhibitory Fc gamma receptor IIB (FCGR2B, CD32B) on follicular lymphoma cells lowers the response rate to rituximab monotherapy (SAKK 35/98). Br — View Citation

Martinelli G, 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 tw — View Citation