A phase II, multicenter study of GlOfitamab in patients with mantle cell Lymphoma and inaDequate response or relapse following CAR T-cell therapy (GOLD)

Conditions

Mantle Cell Lymphoma

Brief summary

Complete Response Rate (CRR) at any time during study treatment (assessed by the independent review committee according to Lugano 2014 criteria)

Detailed description

Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12, Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria), Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause, Overall Survival (OS) defined as the time between the study inclusion and death from any cause, Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death, Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy., Event Free Survival (EFS) defined as the time from the study inclusion to disease progression, death, or Next Anti-Lymphoma Treatment (NALT) start., Frequency and severity of adverse events (AEs) classified as per CTCAE latest version and SAE

Related papers

No related papers found yet.

Interventions

DRUGGLOFITAMAB

DRUGOBINUTUZUMAB

DRUGTOCILIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete Response Rate (CRR) at any time during study treatment (assessed by the independent review committee according to Lugano 2014 criteria)	—

Secondary

Measure	Time frame
Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12, Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria), Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause, Overall Survival (OS) defined as the time between the study inclusion and death from any cause, Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death, Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy., Event Free Survival (EFS) defined as the time from the study inclusion to disease progression	—

Measure

Time frame

Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12, Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria), Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause, Overall Survival (OS) defined as the time between the study inclusion and death from any cause, Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death, Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy., Event Free Survival (EFS) defined as the time from the study inclusion to disease progression

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Outcome results

None listed