NCT00877214

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,272

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
15.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

15.7 years

First QC Date

April 6, 2009

Last Update Submit

August 20, 2024

Conditions

Follicular LymphomasImmunocytomasMarginal Zone LymphomasMantle-Cell LymphomasLymphocytic LymphomaNon-Hodgkin's Lymphoma

Keywords

BendamustineRituximabSignificance of maintenance therapyEfficacy and safety

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Time from randomization until progress or death of any course

    5 years and ongoing

Secondary Outcomes (1)

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

    5 years and ongoing

Study Arms (2)

Rituximab

EXPERIMENTAL

Follicular 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

Drug: Rituximab

Standard

ACTIVE COMPARATOR

Rituximab / Observation

Drug: Rituximab / observation

Interventions

RituximabDRUG

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

Also known as: Mabthera(R), Rituxan(R)
Rituximab
Rituximab / observationDRUG

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)

Also known as: Mabthera(R), Rituxan(R)
Standard

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StiL Head Office; Justus-Liebig-University

Giessen, 35392, Germany

Location

Related Publications (7)

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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).

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-Hodgkin

Interventions

RituximabObservation

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Mathias Rummel, Dr

    University of Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Mathias Rummel

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)