A phase II trial of belimumab in combination with rituximab/venetoclax in patients with refractory or relapsed chronic lymphocytic leukemia

Conditions

refractory or relapsed chronic lymphocytic leukemia

Brief summary

Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by flow cytometry at EOI

Detailed description

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOT, Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOS, Incidence of suicidal behavior, as determined by Columbia-Suicide Severity Rating Scale (CSSRS), Number and percentage of overall response rate (ORR) according to iwCLL criteria: PR, CR, and CRi at EOT, as assessed by the investigator at EOI and EOT, DOR status as time from best ORR of CR, CRi, or PR until progression, Negativity rate of MRD in PB and BM measured by flow cytometry at EOI, every 3 months during maintenance therapy and at EOS, TTNT as time from d1 to next other CLL treatment, Overall and progression free survival, Overall and progression free survival of patients with 17p deletion, Absolute changes in number and percentage of subjects in lymphocyte subset counts (B, T, NK cells) on day28, d1 of each cycle, EOI and thereafter every 4 weeks until EOT from baseline., Pharmacokinetics of belimumab as assessed as follows: o Observed belimumab concentration at c1d1, EOI and EOT, Overall quality of life scores (EORTC QLQ C-30) until EOS

Related papers

No related papers found yet.

Interventions

DRUGBELIMUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Negativity rate of minimal residual disease (MRD) in peripheral blood (PB) measured by flow cytometry at EOI	—

Secondary

Measure	Time frame
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOT, Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOS, Incidence of suicidal behavior, as determined by Columbia-Suicide Severity Rating Scale (CSSRS), Number and percentage of overall response rate (ORR) according to iwCLL criteria: PR, CR, and CRi at EOT, as assessed by the investigator at EOI and EOT, DOR status as time from best ORR of CR, CRi, or PR until progression, Negativity rate of MRD in PB and BM measured by flow cytometry at EOI, every 3 months during maintenance therapy and at EOS, TTNT as time from d1 to next other CLL treatment, Overall and progression free survival, Overall and progression free survival of patients with 17p deletion, Absolute changes in number and percentage of subjects in lymphocyte subset counts (B, T, NK cells) on day28, d1 of each cycle, EOI and thereafter every 4 weeks until EOT from baseline., Pharmacokinetics of be	—

Measure

Time frame

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOT, Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) through EOS, Incidence of suicidal behavior, as determined by Columbia-Suicide Severity Rating Scale (CSSRS), Number and percentage of overall response rate (ORR) according to iwCLL criteria: PR, CR, and CRi at EOT, as assessed by the investigator at EOI and EOT, DOR status as time from best ORR of CR, CRi, or PR until progression, Negativity rate of MRD in PB and BM measured by flow cytometry at EOI, every 3 months during maintenance therapy and at EOS, TTNT as time from d1 to next other CLL treatment, Overall and progression free survival, Overall and progression free survival of patients with 17p deletion, Absolute changes in number and percentage of subjects in lymphocyte subset counts (B, T, NK cells) on day28, d1 of each cycle, EOI and thereafter every 4 weeks until EOT from baseline., Pharmacokinetics of be

—

Countries

Germany

Outcome results

None listed