A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
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| ClinicalTrials.gov Identifier: NCT01144364 |
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Recruitment Status :
Completed
First Posted : June 15, 2010
Results First Posted : December 4, 2014
Last Update Posted : August 15, 2017
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Hodgkin's Lymphoma | Drug: rituximab [Mabthera/Rituxan] | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 234 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-label Study of MabThera Maintenance Therapy Compared With no Further Therapy After a Brief Induction With Chemotherapy Plus MabThera on Failure-free Survival in Treatment-naïve Elderly Patients With Advanced Follicular Lymphoma |
| Actual Study Start Date : | January 19, 2004 |
| Actual Primary Completion Date : | July 21, 2011 |
| Actual Study Completion Date : | July 21, 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: rituximab [Mabthera/Rituxan]
Intravenous repeating dose |
Primary Outcome Measures :
- Percentage of Participants With Disease Progression or Death [ Time Frame: 12, 24, and 34 months ]PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.
- PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months [ Time Frame: 12, 24, and 34 months ]PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.
Secondary Outcome Measures :
- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.
- Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.
- Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months [ Time Frame: 12, 24, and 34 months ]OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
- Overall Survival (OS) From Randomization - Percentage of Participants With Death [ Time Frame: 12, 24, and 34 months ]OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
- OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months [ Time Frame: 12, 24, and 36 months ]OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.
- Percentage of Participants With a Response During the Induction Phase [ Time Frame: Months 1 to 8 ]Participants without a response assessment (due to any reasons) were considered as non-responders.
- Percentage of Participants With a Molecular Response in the Induction Phase [ Time Frame: Months 5 and 8 ]Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.
- Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ]Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.
- Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months [ Time Frame: Months 12, 24, and 34 ]DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.
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| Ages Eligible for Study: | 60 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients 60-75 years of age;
- B-cell follicular NHL;
- no previous treatment;
- active disease, with rapid progression.
Exclusion Criteria:
- other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
- long-term use (>1 month) of systemic corticosteroids;
- central nervous system involvement;
- history of significant cardiovascular disease;
- positive test result for HIV, or hepatitis B or C.
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): NCT01144364
Locations
Show 45 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Chair: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01144364 |
| Other Study ID Numbers: |
ML17638 |
| First Posted: | June 15, 2010 Key Record Dates |
| Results First Posted: | December 4, 2014 |
| Last Update Posted: | August 15, 2017 |
| Last Verified: | June 2017 |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |