NCT00003280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 lymphoma

Timeline
Completed

Started Jan 1998

Shorter than P25 for phase_3 lymphoma

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

September 24, 2003

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4.2 years

First QC Date

November 1, 1999

Last Update Submit

May 13, 2019

Conditions

Lymphoma

Keywords

stage I mantle cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphoma

Interventions

rituximabBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Office of Walter Weber-Stadelman

Basel, CH 4051, Switzerland

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Ospedale San Giovanni

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Burgerspital, Solothurn

Solothurn, 4500, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 20697092RESULT

  • 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.

    PMID: 16030029RESULT

  • 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.

    PMID: 15598978RESULT

  • 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.

    PMID: 25142001RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michele Ghielmini, MD

    Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 24, 2003

Study Start

January 1, 1998

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

CH(10)