ENRICH - Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma

Conditions

Mantle Cell Lymphoma (MCL)

Brief summary

The primary endpoint is progression-free survival (PFS). This is defined as the interval from the date of randomisation to the earlier of the first documentation of disease progression / relapse or death from any cause

Detailed description

Overall survival will be measured from the date of randomisation to the date of death from any cause, Disease response will be assessed in accordance with the International Workshop Standardized Response Criteria for Non-Hodgkin's Lymphoma. Response assessments are to be guided by the Cheson Criteria 1999. Disease response will be formally assessed by CT scans and Bone Marrow biopsies, Safety and toxicity - based on adverse events graded by Common Terminology Criteria for Adverse Event reporting (CTCAE) v4.03 and determined by routine clinical assessment, Quality of life - EORTC QLQ-C30 will be used to measure participant assessed quality of life, Time to next MCL treatment is defined as the interval from the date of randomisation to the start date of next MCL treatment or the date of death from any cause

Related papers

No related papers found yet.

Interventions

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGVINCRISTINE SULFATE

DRUGCYCLOPHOSPHAMIDE

DRUGIMBRUVICA 140 mg hard capsules

DRUGBENDAMUSTINE HYDROCHLORIDE

DRUGPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is progression-free survival (PFS). This is defined as the interval from the date of randomisation to the earlier of the first documentation of disease progression / relapse or death from any cause	—

Secondary

Measure	Time frame
Overall survival will be measured from the date of randomisation to the date of death from any cause, Disease response will be assessed in accordance with the International Workshop Standardized Response Criteria for Non-Hodgkin's Lymphoma. Response assessments are to be guided by the Cheson Criteria 1999. Disease response will be formally assessed by CT scans and Bone Marrow biopsies, Safety and toxicity - based on adverse events graded by Common Terminology Criteria for Adverse Event reporting (CTCAE) v4.03 and determined by routine clinical assessment, Quality of life - EORTC QLQ-C30 will be used to measure participant assessed quality of life, Time to next MCL treatment is defined as the interval from the date of randomisation to the start date of next MCL treatment or the date of death from any cause	—

Measure

Time frame

Overall survival will be measured from the date of randomisation to the date of death from any cause, Disease response will be assessed in accordance with the International Workshop Standardized Response Criteria for Non-Hodgkin's Lymphoma. Response assessments are to be guided by the Cheson Criteria 1999. Disease response will be formally assessed by CT scans and Bone Marrow biopsies, Safety and toxicity - based on adverse events graded by Common Terminology Criteria for Adverse Event reporting (CTCAE) v4.03 and determined by routine clinical assessment, Quality of life - EORTC QLQ-C30 will be used to measure participant assessed quality of life, Time to next MCL treatment is defined as the interval from the date of randomisation to the start date of next MCL treatment or the date of death from any cause

—

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed