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Follicular LymphomasPhase 3MAINTAINNCT00877214

Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

A Phase 3 study testing Rituximab and Rituximab / observation in people with Follicular Lymphomas and Immunocytomas, run by Jurgen Barth at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Rituximab and Rituximab / observation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,272 participants
Where
1 siteGermany
Study dates
1 Apr 2009to Dec 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:
  • Follicular Lymphoma Grade 1 and 2
  • Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
  • Marginal zone lymphoma, nodal and extra nodal
  • Mantle cell lymphoma
  • No prior therapy with cytotoxics, interferon or monoclonal antibodies
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  • Need for therapy, except mantle cell lymphomas
  • Stadium III or IV or Stadium with II bulky disease (> 7 cm diameter, or 3 lesions > 5 cm)
  • General condition WHO 0-2
  • Age min. 18 years, max. 80 years
  • Negative pregnancy test, contraceptives mandatory for women of child-bearing age
  • Actual histology, not older than 6 months required
  • Written informed consent

Who cannot join

  • Patients not meeting the inclusion criteria above
  • Possibility of a primary radiation therapy with curative intention
  • Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
  • Co-morbidities, excluding a therapy according to the protocol:
  • severe, medicinal not adjustable hypertension
  • severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin > 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
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  • severe, medicinal not adjustable diabetes mellitus
  • active autoimmune disease
  • active infection, requiring antibiotic therapy
  • Patients with proven HIV-infection
  • Active replicating hepatitis-Infection
  • Severe psychiatric diseases
  • Lacking or anticipated non-compliance
  • Known hypersensitivity against the active components or additives or mouse- proteins
  • Pregnant or nursing women
  • Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • StiL Head Office; Justus-Liebig-University

    Giessen, 35392

Other trials in Germany

About this study

Official title: Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.

Read the detailed description

Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.

This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Being tested
Rituximab, Rituximab / observation
Keywords
Bendamustine, Rituximab, Significance of maintenance therapy, Efficacy and safety
Medical subject headings
Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • RituximabDrug

    Also called Mabthera(R), Rituxan(R)

    Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years

  • Rituximab / observationDrug

    Also called Mabthera(R), Rituxan(R)

    Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)

Study groups in NCT00877214
Study groupRoleWhat they receive
RituximabExperimentalFollicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection
Receives: Drug: Rituximab
StandardActive comparatorRituximab / Observation
Receives: Drug: Rituximab / observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Time from randomization until progress or death of any course

    Measured: 5 years and ongoing

Secondary outcomes (1)

  1. Remission rate and duration; event free-, progression free-, disease free- and over all survival

    Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse

    Measured: 5 years and ongoing

Timeline

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

  1. First posted7 Apr 2009 (estimated)
  2. Study start1 Apr 2009
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00877214
Sponsor's protocol ID
NHL 7-2008
Acronym
MAINTAIN
Status last verified
Aug 2024
First submitted
6 Apr 2009
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rummel MJ et al. Bendamustin-Rituximab Induction Followed by Observation or Rituximab Maintenance for Newly Diagnosed Patients with Waldenström's Macroglobulinemia: Results From a Prospective, Randomized, Multicenter Study (StiL NHL 7-2008 -MAINTAIN-; ClinicalTrials.gov Identifier: NCT00877214). Blood 2012; 120: 2739. https://doi.org/10.1182/blood.V120.21.2739.2739

  • Immunochemotherapy with Bendamustine-Rituximab (BR) as induction therapy for indolent lymphomas results in a severe lymphopenia with low CD4+ and CD8+ counts without an increase in atypical infections. First results of the infectious disease (ID) project of a prospective, randomized, multicentre study (StiL NHL 7-2008, MAINTAIN; NCT00877214). Hematol Oncol 2013; 31 (Suppl. 1): 106 https://onlinelibrary.wiley.com/doi/pdf/10.1002/hon.2057

  • Rummel MJ et al. Two years rituximab maintenance vs. observation after first-line treatment with bendamustine plus rituximab (B-R) in patients with mantle cell lymphoma: First results of a prospective, randomized, multicenter phase II study (a subgroup study of the StiL NHL7-2008 MAINTAIN trial). DOI: 10.1200/JCO.2016.34.15_suppl.7503 Journal of Clinical Oncology 34, no. 15_suppl (May 2016) 7503-7503.

  • Rummel MJ, et al. Four Versus Two Years of Rituximab Maintenance (R-maintenance) Following Bendamustine Plus Rituximab (B-R): Initial Results of a Prospective, Randomized Multicenter Phase 3 Study in First-Line Follicular Lymphoma (the StiL NHL7-2008 MAINTAIN study). Blood (2017) 130 (Supplement 1): 483.

  • Rummel MJ et al. Two years rituximab maintenance vs. observation after first line treatment with bendamustine plus rituximab (B-R) in patients with marginal zone lymphoma (MZL): Results of a prospective, randomized, multicenter phase 2 study (the StiL NHL7-2008 MAINTAIN trial). DOI: 10.1200/JCO.2018.36.15_suppl.7515 Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 7515-7515

  • Rummel MJ et al. Two years Rituximab maintenance vs. observation after first line treatment with Bendamustine plus Rituximab in patients with Marginal Zone Lymphoma (MZL): results from the StiL NHL7-2008 MAINTAIN trial Results of a prospective, randomized, multicentre phase 2 study (a subgroup study of the StiL NHL7-2008 MAINTAIN trial).

  • Rummel MJ et al. Two Years Rituximab Maintenance Vs. Observation after First Line Treatment with Bendamustine Plus Rituximab (B-R) in Patients with Waldenström's Macroglobulinemia (MW): Results of a Prospective, Randomized, Multicenter Phase 3 Study (the StiL NHL7-2008 MAINTAIN trial). Blood (2019) 134 (Supplement_1): 343. https://doi.org/10.1182/blood-2019-121909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Rituximab / observation in people with Follicular Lymphomas and Immunocytomas, run by Jurgen Barth at 1 site in Germany.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Results are not available in the source record.

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.

What does the primary outcome measure?

Progression free survival (time frame: 5 years and ongoing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00877214, which also lists 7 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 22 Aug 2024.

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