Phase IV study evaluating the efficacy and safety of the venetoclax + rituximab (VR) regimen in patients with relapsed chronic lymphocytic leukemia in Polish clinical practice

Conditions

Adult with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL)

Brief summary

Percentage of patients treated with venetoclax + rituximab (VR) achieving uMRD status, i.e. MRD values <10-4 determined by flow cytometry

Detailed description

Percentage of patients achieving ORR, PR, CR and Cri, uMRD, treated according to the VR regimen in the Ministry of Health drug program, taking into account pharmacoeconomic and systemic parameters including the number of days of hospitalization and visits during 24 months, Percentage of patients achieving ORR, PR, CR and Cri, uMRD with negative prognostic factors: TP53 deletion/mutation, unmutated IGHV gene and high CD38 expression, Occurrence and correlation with treatment outcomes of potential biomarkers, including cytogenetic abnormalities detected by FISH, mutational status of the IGVH gene and TP53 mutations assessed by Sanger or next-generation sequencing (NGS), in patients treated according to the VR regimen, Results of the QLQ-C30 (EORTC QLQ-C30) questionnaires assessing quality of life (QoL), completed by patients before and during treatment, Number of days of hospitalization in each of the studied regimens, taking into account the period related to venetoclax titration

Related papers

No related papers found yet.

Interventions

DRUGMabThera 100 mg concentrate for solution for infusion

DRUGVenclyxto 50 mg film-coated tablets

DRUGVenclyxto 100 mg film-coated tablets

DRUGVenclyxto 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of patients treated with venetoclax + rituximab (VR) achieving uMRD status, i.e. MRD values <10-4 determined by flow cytometry	—

Secondary

Measure	Time frame
Percentage of patients achieving ORR, PR, CR and Cri, uMRD, treated according to the VR regimen in the Ministry of Health drug program, taking into account pharmacoeconomic and systemic parameters including the number of days of hospitalization and visits during 24 months, Percentage of patients achieving ORR, PR, CR and Cri, uMRD with negative prognostic factors: TP53 deletion/mutation, unmutated IGHV gene and high CD38 expression, Occurrence and correlation with treatment outcomes of potential biomarkers, including cytogenetic abnormalities detected by FISH, mutational status of the IGVH gene and TP53 mutations assessed by Sanger or next-generation sequencing (NGS), in patients treated according to the VR regimen, Results of the QLQ-C30 (EORTC QLQ-C30) questionnaires assessing quality of life (QoL), completed by patients before and during treatment, Number of days of hospitalization in each of the studied regimens, taking into account the period related to venetoclax titration	—

Measure

Time frame

Percentage of patients achieving ORR, PR, CR and Cri, uMRD, treated according to the VR regimen in the Ministry of Health drug program, taking into account pharmacoeconomic and systemic parameters including the number of days of hospitalization and visits during 24 months, Percentage of patients achieving ORR, PR, CR and Cri, uMRD with negative prognostic factors: TP53 deletion/mutation, unmutated IGHV gene and high CD38 expression, Occurrence and correlation with treatment outcomes of potential biomarkers, including cytogenetic abnormalities detected by FISH, mutational status of the IGVH gene and TP53 mutations assessed by Sanger or next-generation sequencing (NGS), in patients treated according to the VR regimen, Results of the QLQ-C30 (EORTC QLQ-C30) questionnaires assessing quality of life (QoL), completed by patients before and during treatment, Number of days of hospitalization in each of the studied regimens, taking into account the period related to venetoclax titration

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Outcome results

None listed