- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269113
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
July 21, 2015 updated by: Hoffmann-La Roche
A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 12203
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Berlin, Germany, 13122
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Bochum, Germany, 44791
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Bonn, Germany, 53127
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Borna, Germany, 04552
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Chemnitz, Germany, 09113
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Cottbus, Germany, 03046
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Dresden, Germany, 01307
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Dresden, Germany, 01067
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Dülmen, Germany, 48249
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Erfurt, Germany, 99089
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Frankfurt An Der Oder, Germany, 15236
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Greifswald, Germany, 17475
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Güstrow, Germany, 18273
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Halle, Germany, 06120
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Halle, Germany, 06110
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Halle (saale), Germany, 06120
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Jena, Germany, 07747
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Jena, Germany, 07743
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Leipzig, Germany, 04103
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Leipzig, Germany, 04315
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Magdeburg, Germany, 39130
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Magdeburg, Germany, 39120
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Marburg, Germany, 35043
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Neubrandenburg, Germany, 17036
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Nordhausen, Germany, 99734
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Potsdam, Germany, 14467
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Riesa, Germany, 01589
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Rostock, Germany, 18057
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Rostock, Germany, 18055
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Schwerin, Germany, 19049
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Stralsund, Germany, 18435
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Trier, Germany, 54290
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Zella-mehlis, Germany, 98544
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients >=18 years of age;
- advanced, low-grade non-Hodgkin's and mantle cell lymphoma.
Exclusion Criteria:
- possibility of curative radiation therapy;
- secondary NHL;
- participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
- concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
As prescribed
375mg/m2 iv monthly for 8 cycles
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Active Comparator: 2
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As prescribed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving CR or PR at the End of Therapy
Time Frame: Following completion of 6 cycles (24 weeks)
|
CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks.
This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10^9/L), hemoglobin (Hb) >7.5 millimoles per liter (mmol/L), and platelets less than (<) 100 Gpt/L.
PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.
|
Following completion of 6 cycles (24 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months
Time Frame: 24 months
|
PFS was defined as the interval from randomization date to progression of disease or death from non-Hodgkin's Lymphoma (NHL).
Progression of disease was defined as: increase in the frequency and severity of disease symptoms; occurrence of new nodal or extranodal lymphoma manifestations; volume increase of pre-existing lymphoma manifestations by more than 25%; or increase of splenomegaly by more than 25%.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha equals (=) 5% for difference between the treatment groups.
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24 months
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Overall Survival (OS) - Percentage of Participants Alive at 24 Months
Time Frame: Month 24
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OS was defined as interval from randomization to date of death of any cause.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.
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Month 24
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Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months
Time Frame: Month 24
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EFS was defined as the interval from randomization date to therapy failure.
Therapy failure was defined after 2 cycles as no change (NC) or progression of disease (PD); after 6 cycles as minimal response [MR], NC, or PD); or death from any cause.
NC is defined as tumor regression of <25%, stable disease and progression ≤25%.
PD was defined as the increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, and increase of splenomegaly by more than 25%.
MR was defined as tumor regression between 50% (<50%) and 25% (≥25%) for at least 4 weeks without occurrence of new manifestations.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.
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Month 24
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Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months
Time Frame: Month 24
|
DFS was defined as the interval from first assessment of CR to PD. PD is an increase in the frequency and severity of disease symptoms, the occurrence of new nodal or extranodal lymphoma manifestations, the volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.
|
Month 24
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Response Duration - Percentage of Participants Event Free at 24 Months
Time Frame: Month 24
|
Response duration defined as interval from first assessment of CR/PR to PD. PD is an increase in the frequency and severity of disease symptoms, occurrence of new nodal or extranodal lymphoma manifestations, volume increase of pre-existing lymphoma manifestations by more than 25%, increase of splenomegaly by more than 25%.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.
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Month 24
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Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months
Time Frame: Month 24
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Time to next treatment was defined as the interval from randomization date to the time when new treatment was needed.
Data were analyzed by means of Kaplan-Meier estimators and log-rank tests at the significance level of alpha=5% for difference between the treatment groups.
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Month 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1998
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 22, 2005
First Submitted That Met QC Criteria
December 22, 2005
First Posted (Estimate)
December 23, 2005
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 21, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- M39023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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