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LymphomaPhase 3NCT00003280

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

A Phase 3 study testing rituximab in people with Lymphoma, run by Swiss Cancer Institute at 10 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab
How many people
240 participants
Where
10 sitesSwitzerland
Study dates
Jan 1998to Mar 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Switzerland10 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Office of Walter Weber-Stadelman

    Basel, CH 4051

  • University Hospital

    Basel, CH-4031

  • Ospedale San Giovanni

    Bellinzona, CH-6500

  • Inselspital, Bern

    Bern, CH-3010

  • Hopital Cantonal Universitaire de Geneva

    Geneva, CH-1211

  • Istituto Oncologico della Svizzera Italiana

    Lugano, CH-6900

  • Burgerspital, Solothurn

    Solothurn, 4500

  • City Hospital Triemli

    Zurich, 8063

  • Klinik Hirslanden

    Zurich, CH-8008

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Being tested
rituximab
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
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2003 (estimated)
  2. Study startJan 1998
  3. Primary completionMar 2002
  4. Study completionMar 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003280
Sponsor's protocol ID
SAKK 35/98
Other IDs
SWS-SAKK-35/98, ICR-35/98, EU-98009
Status last verified
May 2019
First submitted
1 Nov 1999
Last updated
15 May 2019
Results posted
No

Publications

  • 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.

    PubMed 20697092

  • 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.

    PubMed 16030029

  • 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.

    PubMed 15598978

  • 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.

    PubMed 25142001

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab in people with Lymphoma, run by Swiss Cancer Institute at 10 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003280, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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Clinical Trial NCT00003280 | AzTrials