A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas

June 26, 2017 updated by: Hoffmann-La Roche

An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma

This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
        • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
      • Pescara, Abruzzo, Italy, 65124
        • Ospedale Civile; Divisione Di Oncologia
    • Basilicata
      • Rionero in Vulture, Basilicata, Italy, 85028
        • Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89100
        • Ospedale Riuniti; Divisione Di Ematologia
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
      • Milano, Lombardia, Italy, 20122
        • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
      • Milano, Lombardia, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
    • Piemonte
      • Alessandria, Piemonte, Italy, 15121
        • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
      • Cuneo, Piemonte, Italy, 12100
        • Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
      • Torino, Piemonte, Italy, 10126
        • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
    • Sicilia
      • Messina, Sicilia, Italy, 98165
        • Az. Osp. Papardo; Struttura Complessa Di Ematologia
    • Toscana
      • Firenze, Toscana, Italy, 50135
        • Az. Osp. Di Careggi; Divisione Di Ematologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients 18-65 years of age;
  • previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
  • active disease;
  • >=3 involved sites.

Exclusion Criteria:

  • typical chronic lymphocytic leukemia;
  • other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
  • systemic corticosteroid use for >1 month;
  • significant cardiovascular disease;
  • central nervous system involvement;
  • hepatitis B or C virus infection, or HIV infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: rituximab
1
Other Names:
  • MabThera/Rituxan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
Time Frame: Month 28
Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
Month 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase
Time Frame: Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.
Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
Percentage of Participants Achieving a Response by Response Type and Study Phase
Time Frame: Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40
CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.
Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40
Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Percentage of Participants With an Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Time to Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Overall Survival (OS) - Percentage of Participants Estimated to be Alive
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
OS - Percentage of Participants With an Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
OS was defined as the time from first dosage of study drug to the date of death from any cause.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
OS - Time to Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DFS - Percentage of Participants With an Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
DFS - Time to Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
PFS - Percentage of Participants With an Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
PFS - Time to Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR - Percentage of Participants With an Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR - Time to Event
Time Frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML18324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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