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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
1
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, Italy
Ospedale Civile; Divisione Di Oncologia
Pescara, Abruzzo, Italy
Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date
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.
Time frame: Month 28
Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study 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.
Time frame: Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)
Percentage of Participants Achieving a Response by Response Type and Study 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.
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Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia
Rionero in Vulture, Basilicate, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, 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
Universita' Degli Studi La Sapienza-Ist.Di Ematologia;Dip. Biotecnologie Cel CELLULARI ED EMATOLOGIA
Rome, Lazio, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardy, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, Italy
...and 5 more locations
Time frame: Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40
Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Percentage of Participants With an Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
FFS - Time to Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Overall Survival (OS) - Percentage of Participants Estimated to be Alive
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
OS - Percentage of Participants With an Event
OS was defined as the time from first dosage of study drug to the date of death from any cause.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
OS - Time to Event
Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DFS - Percentage of Participants With an Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
DFS - Time to Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.
Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
PFS - Percentage of Participants With an Event
Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
PFS - Time to Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR - Percentage of Participants With an Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40
DR - Time to Event
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.
Time frame: Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40