A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00269113
First received: December 22, 2005
Last updated: July 21, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab [MabThera/Rituxan]
Drug: Standard chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Achieving CR or PR at the End of Therapy [ Time Frame: Following completion of 6 cycles (24 weeks) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) - Percentage of Participants Alive at 24 Months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    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.

  • Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    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.

  • Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    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.

  • Response Duration - Percentage of Participants Event Free at 24 Months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    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.

  • Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 360
Study Start Date: September 1998
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv monthly for 8 cycles
Drug: Standard chemotherapy
As prescribed
Active Comparator: 2 Drug: Standard chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269113

Locations
Germany
Berlin, Germany, 12203
Berlin, Germany, 13122
Bochum, Germany, 44791
Bonn, Germany, 53127
Borna, Germany, 04552
Chemnitz, Germany, 09113
Cottbus, Germany, 03046
Dresden, Germany, 01067
Dresden, Germany, 01307
Dülmen, Germany, 48249
Erfurt, Germany, 99089
Frankfurt An Der Oder, Germany, 15236
Greifswald, Germany, 17475
Güstrow, Germany, 18273
Halle, Germany, 06110
Halle, Germany, 06120
Halle (saale), Germany, 06120
Jena, Germany, 07743
Jena, Germany, 07747
Leipzig, Germany, 04103
Leipzig, Germany, 04315
Magdeburg, Germany, 39120
Magdeburg, Germany, 39130
Marburg, Germany, 35043
Neubrandenburg, Germany, 17036
Nordhausen, Germany, 99734
Potsdam, Germany, 14467
Riesa, Germany, 01589
Rostock, Germany, 18055
Rostock, Germany, 18057
Schwerin, Germany, 19049
Stralsund, Germany, 18435
Trier, Germany, 54290
Zella-mehlis, Germany, 98544
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00269113     History of Changes
Other Study ID Numbers: M39023
Study First Received: December 22, 2005
Results First Received: May 20, 2014
Last Updated: July 21, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015