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Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants

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ClinicalTrials.gov Identifier: NCT02536664
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.

Condition or disease Intervention/treatment
Follicular Lymphoma Drug: Rituximab

Study Design
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Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RIM - Rituximab in Maintenance
Study Start Date : September 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Groups and Cohorts
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Group/Cohort Intervention/treatment
First-line Stratum
Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.
 Drug: Rituximab
Other Name: MabThera®
Relapsed/Refractory Stratum
Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.
 Drug: Rituximab
Other Name: MabThera®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Who Were Alive and Free From Progressive Disease [ Time Frame: 2 years ]
    Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.


Secondary Outcome Measures :
  1. Median Progression Free Survival (PFS) Time [ Time Frame: 2 years ]
    PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.

  2. Percentage of Participants Who Were Alive [ Time Frame: 2 years ]
    Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.

  3. Median Overall Survival (OS) Time [ Time Frame: 2 years ]
    Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.

  4. Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy [ Time Frame: 2 years ]
    CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.

  5. Percentage of Participants With Best Overall Response [ Time Frame: 2 years ]
    The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

  6. Percentage of Participants With Initiation of New Therapy [ Time Frame: 2 years ]
    Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.


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
Sampling Method:   Non-Probability Sample
Study Population
Participants with follicular lymphoma who are to be treated with Rituximab in the maintenance dosing period as decided by the physician
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Previously untreated, relapsed or refractory CD 20-positive FL
  • Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
  • To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
  • No ineligibility for rituximab

Exclusion Criteria:

Not Applicable (NA)

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): NCT02536664


Locations
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Germany
Essen, Germany, 45122
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: NCT02536664    
Other Study ID Numbers: ML22283
First Posted: September 1, 2015    Key Record Dates
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents