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A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT02569996
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Drug: Rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase III, Open-label Study Evaluating the Benefit of a Long-term Effect of MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma After Induction of Response (CR[u] or PR) With MabThera (Rituximab) Containing First-line Regimen
Study Start Date : July 2005
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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
Participants will receive rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
 Drug: Rituximab
Rituximab will be administered at 375 mg/m^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
Other Name: MabThera/Rituxan


Outcome Measures
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Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years ]
    Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 27 months ]
    An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death

  2. Overall Survival (OS) [ Time Frame: From randomization until death, assessed up to 5 years ]
    Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

  3. Time to Progression (TTP) [ Time Frame: From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years ]
    Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.

  4. Time to Next Anti-lymphoma Treatment (TTNLT) [ Time Frame: From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years ]
    Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

  5. Duration of Response (DR) [ Time Frame: From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years ]
    Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.

  6. Disease-free Survival (DFS) [ Time Frame: From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years ]
    Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.


Eligibility Criteria
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Information from the National Library of Medicine

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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 greater than (>) 18 years of age
  • Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
  • No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
  • Verified complete or partial remission after first-line induction therapy including rituximab

Exclusion Criteria:

  • Grade 3b follicular lymphoma
  • Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
  • Presence of central nervous system lymphoma
  • Acquired immunodeficiency syndrome-related lymphoma
  • Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years
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): NCT02569996


Locations
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Hungary
Budapest, Hungary, 1071
Budapest, Hungary, 1083
Budapest, Hungary, 1085
Budapest, Hungary, 1088
Budapest, Hungary, 1122
Budapest, Hungary, 1135
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Miskolc, Hungary, 3529
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7624
Szeged, Hungary, 6720
Szekszard, Hungary, 7100
Szolnok, Hungary, 5004
Szombathely, Hungary, 9700
Székesfehérvár, Hungary, 8000
Tatabánya, Hungary, 2800
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02569996    
Other Study ID Numbers: ML18167
First Posted: October 7, 2015    Key Record Dates
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015
Last Verified: November 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