A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
- Registration Number
- NCT01153971
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- adult patients 18-65 years of age;
- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- active disease;
- >=3 involved sites.
- typical chronic lymphocytic leukemia;
- other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
- systemic corticosteroid use for >1 month;
- significant cardiovascular disease;
- central nervous system involvement;
- hepatitis B or C virus infection, or HIV infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 rituximab -
- Primary Outcome Measures
Name Time Method Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date Month 28 Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase) CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (\>)1,500 per microliter (/µL), hemoglobin \>12 grams per deciliter (g/dL), platelets \>100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.
Percentage of Participants Achieving a Response by Response Type and Study Phase Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40 CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (\>)1,500 per microliter (/µL), hemoglobin \>12 grams per deciliter (g/dL), platelets \>100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.
Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.
FFS - Percentage of Participants With an Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.
FFS - Time to Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Overall Survival (OS) - Percentage of Participants Estimated to be Alive Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.
OS - Percentage of Participants With an Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. OS was defined as the time from first dosage of study drug to the date of death from any cause.
OS - Time to Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.
DFS - Percentage of Participants With an Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.
DFS - Time to Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.
PFS - Percentage of Participants With an Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.
PFS - Time to Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
DR - Percentage of Participants With an Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.
DR - Time to Event Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40 DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.
Trial Locations
- Locations (15)
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
🇮🇹Roma, Lazio, Italy
Ospedale Civile; Divisione Di Oncologia
🇮🇹Pescara, Abruzzo, Italy
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
🇮🇹Modena, Emilia-Romagna, Italy
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
🇮🇹Messina, Sicilia, Italy
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
🇮🇹Pescara, Abruzzo, Italy
Ospedale Riuniti; Divisione Di Ematologia
🇮🇹Reggio Calabria, Calabria, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
🇮🇹Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
🇮🇹Alessandria, Piemonte, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
🇮🇹Torino, Piemonte, Italy
Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
🇮🇹Rionero in Vulture, Basilicata, Italy
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
🇮🇹Cuneo, Piemonte, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
🇮🇹Brescia, Lombardia, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
🇮🇹Firenze, Toscana, Italy