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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269113
• Other study ID #: M39023
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: July 21, 2015
• Start date: September 1998
• Est. completion date: April 2009

Study information

• Verified date: July 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• rituximab [MabThera/Rituxan]
375mg/m2 iv monthly for 8 cycles
• Standard chemotherapy
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving CR or PR at the End of Therapy	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)	No
Secondary	Progression-Free Survival (PFS) - Percentage of Participants Event Free at 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.	24 months	No
Secondary	Overall Survival (OS) - Percentage of Participants Alive at 24 Months	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.	Month 24	No
Secondary	Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months	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.	Month 24	No
Secondary	Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months	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	No
Secondary	Response Duration - Percentage of Participants Event Free at 24 Months	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.	Month 24	No
Secondary	Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months	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.	Month 24	No