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

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ClinicalTrials.gov Identifier: NCT01144403
Recruitment Status : Terminated
First Posted : June 15, 2010
Results First Posted : August 29, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: Cyclophosphamide Drug: Fludarabine Drug: Mitoxantrone Drug: Rituximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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
Study Start Date : June 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01144403    
Other Study ID Numbers: ML22489
2009-011433-27
First Posted: June 15, 2010    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: October 18, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cyclophosphamide
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
Antineoplastic Agents, Immunological
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors