We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01144403
First Posted: June 15, 2010
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.

Condition Intervention Phase
Diffuse Large B-Cell Lymphoma Drug: Cyclophosphamide Drug: Fludarabine Drug: Mitoxantrone Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Up to 50 months (approximately) ]
    Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From the time of enrollment until death due to any cause (up to 50 months [approximately]) ]
    Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.

  • Progression-free Survival (PFS) [ Time Frame: From the time of enrollment until death due to any cause (up to 50 months [approximately]) ]
    PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.

  • Number of Participant With Adverse Event (AE) [ Time Frame: Up to 50 months (approximately) ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.


Enrollment: 8
Study Start Date: June 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Drug: Cyclophosphamide
as prescribed, 6 cycles
Drug: Fludarabine
as prescribed, 6 cycles
Drug: Mitoxantrone
as prescribed, 6 cycles
Drug: Rituximab
375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Other Name: Mabthera/Rituxan

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult participants, >/=18 years of age
  • untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
  • known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • adequate hematological, renal and hepatic function

Exclusion Criteria:

  • known hypersensitivity to murine proteins or chemotherapy regimen
  • previous first-line therapy
  • history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
  • active infection
  • clinically significant cardiac disease
  • regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144403


Locations
Romania
Brasov, Romania, 500326
Bucharest, Romania, 005098
Bucharest, Romania, 022328
Bucuresti, Romania, 030171
Cluj-Napoca, Romania, 400015
Iasi, Romania, 700111
Targu-mures, Romania, 540136
Timisoara, Romania, 300079
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01144403     History of Changes
Other Study ID Numbers: ML22489
2009-011433-27
First Submitted: June 14, 2010
First Posted: June 15, 2010
Results First Submitted: June 20, 2016
Results First Posted: August 29, 2016
Last Update Posted: October 18, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Fludarabine phosphate
Rituximab
Fludarabine
Mitoxantrone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Analgesics
Sensory System Agents
Peripheral Nervous System Agents