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An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01684865
First received: September 11, 2012
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.

Condition Intervention
Non-Hodgkin's Lymphoma
Drug: Rituximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]

Secondary Outcome Measures:
  • Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma [ Time Frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) ]
  • Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma [ Time Frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) ]
  • Time to Next Anti-Lymphoma Treatment (TTNLT) [ Time Frame: Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years) ]
  • Time to Next Chemotherapy Treatment (TTNCT) [ Time Frame: Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years) ]
  • Overall Survival [ Time Frame: Baseline up to death (up to approximately 3 years) ]
  • Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma [ Time Frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]) ]
  • Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma [ Time Frame: Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years]) ]

Enrollment: 22
Actual Study Start Date: October 22, 2012
Estimated Study Completion Date: July 13, 2018
Estimated Primary Completion Date: July 13, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-Hodgkin's Lymphoma Participants
Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression. Participants will be followed for one year after last dose of rituximab administered as maintenance.
Drug: Rituximab
Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.
Other Name: MabThera®, Rituxan®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with follicular non-Hodgkin's lymphoma receiving first-line rituximab maintenance treatment
Criteria

Inclusion Criteria:

  • Histological diagnosis of follicular non-Hodgkin's lymphoma
  • Complete or partial response to first-line induction therapy with chemotherapy with rituximab
  • Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label

Exclusion Criteria:

  • Pregnant or lactating women
  • Receipt of an investigational drug within 30 days prior to initiation of observational drug
  • Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent
  • Central nervous system involvement
  • Hepatitis B or C virus infection or human immunodeficiency virus infection
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684865

Locations
Macedonia, The Former Yugoslav Republic of
University Clinic of Hematology Skopje, Hospital Care Department
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01684865     History of Changes
Other Study ID Numbers: ML27993
Study First Received: September 11, 2012
Last Updated: May 1, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 25, 2017