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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
rituximab
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonspital Aarau
  • Office of Walter Weber-Stadelman
  • University Hospital
  • Ospedale San Giovanni
  • Inselspital, Bern
  • Hopital Cantonal Universitaire de Geneva
  • Istituto Oncologico della Svizzera Italiana
  • Burgerspital, Solothurn
  • City Hospital Triemli
  • Klinik Hirslanden

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 13, 2019
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00003280
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rituximab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Ghielmini, MD
Organizational Affiliation
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Office of Walter Weber-Stadelman
City
Basel
ZIP/Postal Code
CH 4051
Country
Switzerland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneva
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Istituto Oncologico della Svizzera Italiana
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Burgerspital, Solothurn
City
Solothurn
ZIP/Postal Code
4500
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Klinik Hirslanden
City
Zurich
ZIP/Postal Code
CH-8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20697092
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 two different schedules in trial SAKK 35/98. J Clin Oncol. 2010 Oct 10;28(29):4480-4. doi: 10.1200/JCO.2010.28.4786. Epub 2010 Aug 9.
Results Reference
result
PubMed Identifier
16030029
Citation
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. doi: 10.1093/annonc/mdi320. Epub 2005 Jul 19.
Results Reference
result
PubMed Identifier
15598978
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 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. doi: 10.1200/JCO.2005.04.164. Epub 2004 Dec 14.
Results Reference
result
PubMed Identifier
25142001
Citation
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 J Haematol. 2015 Jan;168(1):145-8. doi: 10.1111/bjh.13071. Epub 2014 Aug 21. No abstract available.
Results Reference
result

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

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