Efficacy of Venetoclax in combination with Rituximab in Waldenström’s Macroglobulinemia

Conditions

Waldenström’s Macroglobulinemia

Brief summary

Rate of complete remission (CR) or very good partial remission (VGPR) 12 months after randomization using the modified response criteria updated at the Sixth IWWM (CR/VGPR).

Detailed description

Interim Response (C4D1; C7D1 (arm A) / 28 days after C6D1 (arm B); C10D1 (arm A) / post treatment staging 1 (arm B), Response and response rate: Overall response rate (CR, VGPR, PR, MR) 12 months after randomization; Major Response rate (CR, VGPR, PR) 12 months from randomization, Best response from randomization up to 24 months, Time to first overall response within 24 months from start of treatment, Time to first major response within 24 months from start of treatment, Event free survival (EFS), Response duration (RD), Progression free survival (PFS), Lymphoma specific survival (LSS), Overall survival (OS), Safety, Quality of life, Comparison of response rates between CXCR4 mutated and CXCR4 wildtype patients

Related papers

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Interventions

DRUGRuxience 500 mg concentrate for solution for infusion

DRUGCYCLOPHOSPHAMIDE

DRUGRITUXIMAB

DRUGVenetoclax

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of complete remission (CR) or very good partial remission (VGPR) 12 months after randomization using the modified response criteria updated at the Sixth IWWM (CR/VGPR).	—

Secondary

Measure	Time frame
Interim Response (C4D1; C7D1 (arm A) / 28 days after C6D1 (arm B); C10D1 (arm A) / post treatment staging 1 (arm B), Response and response rate: Overall response rate (CR, VGPR, PR, MR) 12 months after randomization; Major Response rate (CR, VGPR, PR) 12 months from randomization, Best response from randomization up to 24 months, Time to first overall response within 24 months from start of treatment, Time to first major response within 24 months from start of treatment, Event free survival (EFS), Response duration (RD), Progression free survival (PFS), Lymphoma specific survival (LSS), Overall survival (OS), Safety, Quality of life, Comparison of response rates between CXCR4 mutated and CXCR4 wildtype patients	—

Measure

Time frame

Interim Response (C4D1; C7D1 (arm A) / 28 days after C6D1 (arm B); C10D1 (arm A) / post treatment staging 1 (arm B), Response and response rate: Overall response rate (CR, VGPR, PR, MR) 12 months after randomization; Major Response rate (CR, VGPR, PR) 12 months from randomization, Best response from randomization up to 24 months, Time to first overall response within 24 months from start of treatment, Time to first major response within 24 months from start of treatment, Event free survival (EFS), Response duration (RD), Progression free survival (PFS), Lymphoma specific survival (LSS), Overall survival (OS), Safety, Quality of life, Comparison of response rates between CXCR4 mutated and CXCR4 wildtype patients

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Countries

Germany, Greece

Outcome results

None listed