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

• ClinicalTrials.gov Identifier: NCT00269113
• Recruitment Status: Completed
• First Posted: December 23, 2005
• Results First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab [MabThera/Rituxan]; Drug: Standard chemotherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: September 1998
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Overall Survival (OS) - Percentage of Participants Alive at 24 Months [ Time Frame: Month 24 ]
   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.
3. Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months [ Time Frame: Month 24 ]
   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.
4. 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.
5. 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.
6. Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months [ Time Frame: Month 24 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 (saale), Germany, 06120

Halle, Germany, 06110

Halle, 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

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00269113
• Other Study ID Numbers: M39023
• First Posted: December 23, 2005
• Results First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Last Verified: July 2015

Additional relevant MeSH terms:

Lymphoma; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents