A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
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ClinicalTrials.gov Identifier: NCT02569996 |
Recruitment Status :
Completed
First Posted : October 7, 2015
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Follicular | Drug: Rituximab | Phase 3 |
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 |

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.
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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 |
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Chair: | Clinical Trials | Hoffmann-La Roche |
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 |
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 |