HOVON 176: Golcadomide (CC-99282) for relapsed and refractory primary large B-cell lymphoma of the central nervous system and secondary central nervous system lymphoma: a phase 2 study

Conditions

secondary central nervous system lymphoma, Relapsed primary large B-cel lymphoma of the central nervous system, refractory primary large B-cell lymphoma of the central nervous system

Brief summary

Best overall response achieved during the first 13 treatment cycles

Detailed description

Toxicity according to the CTCAE grading, Time to best response, PFS as measured from time of start study treatment until progression or death, OS as measured from time of start study treatment until death of any cause, DOR as measured from first documentation of response until relapse or progression or death, Functional status by MMSE and QoL EORTC QLQ-C30 and EORTC QLQ-BN20, Exploratory endpoint: PK of golcadomide in spinal fluid as compared to plasma, Exploratory endpoint: To examine the value of ctDNA in plasma and spinal fluid for detection of minimal residual disease and the correlation with clinical outcome, Exploratory endpoint: Correlation between mutational and GEP profiles and response to treatment

Related papers

No related papers found yet.

Interventions

DRUGGolcadomide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Best overall response achieved during the first 13 treatment cycles	—

Secondary

Measure	Time frame
Toxicity according to the CTCAE grading, Time to best response, PFS as measured from time of start study treatment until progression or death, OS as measured from time of start study treatment until death of any cause, DOR as measured from first documentation of response until relapse or progression or death, Functional status by MMSE and QoL EORTC QLQ-C30 and EORTC QLQ-BN20, Exploratory endpoint: PK of golcadomide in spinal fluid as compared to plasma, Exploratory endpoint: To examine the value of ctDNA in plasma and spinal fluid for detection of minimal residual disease and the correlation with clinical outcome, Exploratory endpoint: Correlation between mutational and GEP profiles and response to treatment	—

Measure

Time frame

Toxicity according to the CTCAE grading, Time to best response, PFS as measured from time of start study treatment until progression or death, OS as measured from time of start study treatment until death of any cause, DOR as measured from first documentation of response until relapse or progression or death, Functional status by MMSE and QoL EORTC QLQ-C30 and EORTC QLQ-BN20, Exploratory endpoint: PK of golcadomide in spinal fluid as compared to plasma, Exploratory endpoint: To examine the value of ctDNA in plasma and spinal fluid for detection of minimal residual disease and the correlation with clinical outcome, Exploratory endpoint: Correlation between mutational and GEP profiles and response to treatment

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Countries

Belgium, Netherlands

Outcome results

None listed