Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

Conditions

Hodgkin lymphoma

Brief summary

Complete metabolic response (CMR) rate assessed by PET/CT 6–8 weeks after completion of chemotherapy.

Detailed description

Progression-Free Survival (PFS), assessed during the whole study period., Event-Free Survival (EFS), assessed during the whole study period., Quality of life (QoL) assessed using the EORTC QLQ-HL27 questionnaire, evaluated before treatment, after 2 cycles of chemotherapy, at the end of chemotherapy, and at each follow-up visit., Treatment-related morbidity (TRMB), assessed as the frequency of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), evaluated after each cycle of chemotherapy., Gonadal recovery assessed by follicle-stimulating hormone (FSH) measurement, evaluated 1 year after completion of chemotherapy., Negative residual disease status assessed by circulating tumor DNA (ctDNA) concentration and thymus and activation-regulated chemokine (TARC) concentration, evaluated after 2 chemotherapy cycles and at the end of chemotherapy (at the time of PET assessment)., Overall survival (OS), assessed during the whole study period.

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Interventions

DRUGNIVOLUMAB

DRUGETOPOSIDE

DRUGDEXAMETHASONE

DRUGDoxorubicin-Ebewe

DRUG2 mg/ml

DRUGkoncentrat do sporzadzania roztworu do infuzji

DRUGVINBLASTINE SULFATE

DRUGDACARBAZINE

DRUGDexaven

DRUG4 mg/ml

DRUGroztwór do wstrzykiwań

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGBRENTUXIMAB VEDOTIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete metabolic response (CMR) rate assessed by PET/CT 6–8 weeks after completion of chemotherapy.	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS), assessed during the whole study period., Event-Free Survival (EFS), assessed during the whole study period., Quality of life (QoL) assessed using the EORTC QLQ-HL27 questionnaire, evaluated before treatment, after 2 cycles of chemotherapy, at the end of chemotherapy, and at each follow-up visit., Treatment-related morbidity (TRMB), assessed as the frequency of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), evaluated after each cycle of chemotherapy., Gonadal recovery assessed by follicle-stimulating hormone (FSH) measurement, evaluated 1 year after completion of chemotherapy., Negative residual disease status assessed by circulating tumor DNA (ctDNA) concentration and thymus and activation-regulated chemokine (TARC) concentration, evaluated after 2 chemotherapy cycles and at the end of chemotherapy (at the time of PET assessment)., Overall survival (OS), assessed during the whole study period.	—

Measure

Time frame

Progression-Free Survival (PFS), assessed during the whole study period., Event-Free Survival (EFS), assessed during the whole study period., Quality of life (QoL) assessed using the EORTC QLQ-HL27 questionnaire, evaluated before treatment, after 2 cycles of chemotherapy, at the end of chemotherapy, and at each follow-up visit., Treatment-related morbidity (TRMB), assessed as the frequency of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), evaluated after each cycle of chemotherapy., Gonadal recovery assessed by follicle-stimulating hormone (FSH) measurement, evaluated 1 year after completion of chemotherapy., Negative residual disease status assessed by circulating tumor DNA (ctDNA) concentration and thymus and activation-regulated chemokine (TARC) concentration, evaluated after 2 chemotherapy cycles and at the end of chemotherapy (at the time of PET assessment)., Overall survival (OS), assessed during the whole study period.

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Outcome results

None listed