A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-27

Study Completion Date

2011-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

NCT01144403

Diffuse Large B-Cell Lymphoma

TERMINATED PHASE2

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

NCT00269113

Non-Hodgkin's Lymphoma

COMPLETED PHASE3

A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

NCT01144364

Non-Hodgkin's Lymphoma

COMPLETED PHASE3

A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

NCT02569996

Lymphoma, Follicular

COMPLETED PHASE3

MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

NCT00430352

Non-Hodgkin's Lymphoma

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mantle Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

375mg/m2 iv every 3 weeks

First line chemotherapy

Intervention Type DRUG

As prescribed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab [MabThera/Rituxan]

375mg/m2 iv every 3 weeks

Intervention Type DRUG

First line chemotherapy

As prescribed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* histologically-proven mantle cell lymphoma;
* previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria

* known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
* active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
* serious disorders interfering with full standard dosing chemotherapy;
* stage I disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No