Phase II Study of Age‐Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With Mantle Cell Lymphoma (FIL-RBAC500)
A phase 2 study of standard R‐BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara‐c 800 mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine + ara‐c combination had very good clinical activity, but a quite relevant hematological toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano Conference, Poster 236).
The primary objective is to determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age‐adjusted Rituximab‐Bendamustine‐Cytarabine (RBAC500) regimen at the end of treatment in older untreated patients with MCL.
The secondary objectives are to determine:
- The rate of molecular response (characterized by labs of the FIL)
- The progression‐free survival (PFS)
- The overall survival (OS)
- The duration of responses (DOR)
- The rate of patients that complete the expected treatment schedule (6 courses)
- The rate of patients that are subject to dose reductions or delays
|Mantle Cell Lymphoma||Drug: Rituximab, Bendamustine, Cytarabine.||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Age‐Adjusted R‐BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)|
- complete remission rate at the end of treatment [ Time Frame: 6 months ]The primary objective is to determine the activity [complete remission rate (CR) according to Cheson 2007 criteria]
- Toxicity will be represented by the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity [ Time Frame: 6 months ]
Grade 4 cytopenia lasting for more than 6 days or Grade 3-4 non-hematologic toxicity or Febrile neutropenia lasting for more than 3 consecutive days.
Stop treatment criteria:
- Occurrence of relevant toxicity for two subsequent or consecutive cycles.
- Grade 3-4 hematological or non-hematological toxicity on day +28 of a cycle not resolving within two weeks.
- Grade 3-4 hematological or non-hematological toxicity on day +28 of a cycle after 25% dose reduction.
- Patient refusal to procede with further cycles due to perceived excessive toxicity.
- Any unpredictable drug related event that suggests against study continuation
- the rate of molecular response [ Time Frame: 6 months ]the rate of molecular response (characterized by labs of the FIL)
- the progression-free survival (PFS) [ Time Frame: 30 months ]the progression-free survival (PFS)is defined as the time from enrollment to complete remission with disappearance of all evidence of disease, disease progression or relapse or death from any cause.
- the overall survival (OS) [ Time Frame: 30 months ]the overall survival (OS) is defined as the time from enrollment to death from any cause
- the duration of responses (DOR) [ Time Frame: 30 months ]the duration of responses (DOR)
- the rate of completion of treatment [ Time Frame: 6 months ]the rate of patients that complete the expected treatment schedule (6 courses)
- the rate of dose reductions or delays [ Time Frame: 6 months ]the rate of patients that are subject to dose reductions or delays
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||January 2017|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
One arm for all patients.
Drug: Rituximab, Bendamustine, Cytarabine.
6 cycles of 28 days with Rituximab, Bendamustine and Cytarabine (R-BAC). Rituximab 375mg/mq; Bendamustine 70mg/mq; Cytarabine 500mg/mq.
Study End points Primary efficacy end point of the study is the proportion of CR defined according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety end point is the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity, as above defined.
Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular response is the proportion of patients with molecular rearrangements at baseline that become negative during treatment, measured by qualitative and quantitative PCR.
OS is measured from enrollment until death from any cause. PFS is measured from the time of enrollment until disease progression, relapse or death from any cause. DOR is measured from the first assessment that documents response (CR or PR) to the date of disease relapse or progression. Minimum follow up required for all patients will be 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662050
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