Mantle Cell Lymphoma
Conditions
Brief summary
Rate of complete remission (CR) achieved at 12 months of I+R combination.
Detailed description
To determine the overall response rate (ORR) at 12 months, Progression free survival (PFS), duration of response (DOR) and overall survival (OS)., To determine the rate of negative minimal residual disease (MRD), the time to obtain a molecular response and the median duration of the molecular response in I+R responding patients., Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during I+R treatment, To assess the health-related quality of life (QOL) during treatment., Genomic studies in indolent clinical forms of MCL (IGHV mutational status, DNA copy-number and whole exome sequencing)
Interventions
Sponsors
Fundacion Geltamo
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete remission (CR) achieved at 12 months of I+R combination. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the overall response rate (ORR) at 12 months, Progression free survival (PFS), duration of response (DOR) and overall survival (OS)., To determine the rate of negative minimal residual disease (MRD), the time to obtain a molecular response and the median duration of the molecular response in I+R responding patients., Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during I+R treatment, To assess the health-related quality of life (QOL) during treatment., Genomic studies in indolent clinical forms of MCL (IGHV mutational status, DNA copy-number and whole exome sequencing) | — |
Countries
Spain
Outcome results
None listed