DALY 2-EU

Phase 2

Active, not recruiting

Conditions: Relapsed/refractory diffuse large B cell lymphoma (R-R DLBCL)

Registration Number: 2023-506270-13-00

Lead Sponsor: Miltenyi Biomedicine GmbH

Brief Summary: The primary objective is to determine superiority of MB-CART2019.1 treatment compared to standard of care (SoC) therapy with R-GemOx (rituximab, gemcitabine and oxaliplatin) with respect to event-free survival in second-line therapy in participants with R-R DLBCL, who are non-eligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 168

Inclusion Criteria

Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification

Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures

In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations

Mental capacity and legal ability to consent to participation in the clinical study.

Relapsed or refractory disease after first-line chemoimmunotherapy

Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody).

Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan.

Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician’s assessment

Age ≥ 18 years

Measurable disease according to Lugano criteria. The lesion must be measurable (nodes > 1.5 cm in the long axis; extranodal lesions > 1 cm in the long axis) and positive on a positron emission tomography scan

Estimated life expectancy of > 3 months for other reasons than the primary disease

Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures

Exclusion Criteria

Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.

Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.

Participants who have received more than one line of treatment for DLBCL or associated subtypes.

Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) < 3 months at the time of leukapheresis.

ECOG performance status > 2

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.		Event-free survival (EFS), defined as the time between the date of randomisation and the date of objective disease progression, failure to achieve partial response (PR) or complete response (CR) at or beyond Week 8 after randomisation leading to a new anti-lymphoma therapy or death of any cause, whichever occurs first, based on independent review committee (IRC) assessment.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS), defined as the time between the date of randomisation and the date of objective disease progression or death of any cause, whichever occurs first, based on IRC assessment.		Progression-free survival (PFS), defined as the time between the date of randomisation and the date of objective disease progression or death of any cause, whichever occurs first, based on IRC assessment.
Best complete response rate (BCRR), defined as the proportion of participants with at least one CR assessment until Week 24 in the MB-CART2019.1 arm and Week 26 in the comparator arm based on IRC assessment.		Best complete response rate (BCRR), defined as the proportion of participants with at least one CR assessment until Week 24 in the MB-CART2019.1 arm and Week 26 in the comparator arm based on IRC assessment.
Duration of complete response (DOCR), defined as the time between the date of a first CR and the date of assessment of objective disease progression or the date of death of any cause, whichever occurs first, based on IRC assessment.		Duration of complete response (DOCR), defined as the time between the date of a first CR and the date of assessment of objective disease progression or the date of death of any cause, whichever occurs first, based on IRC assessment.
Overall survival (OS), defined as time between the date of randomisation and the date of death of any cause.		Overall survival (OS), defined as time between the date of randomisation and the date of death of any cause.

Trial Locations

Locations (52): Institut Catala D'oncologia
🇪🇸
L'hospitalet De Llobregat, Spain
Hospital Universitario De Salamanca
🇪🇸
Salamanca, Spain
Hospital Clinic De Barcelona
🇪🇸
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸
Madrid, Spain
Clinica Universidad De Navarra
🇪🇸
Madrid, Spain
University Clinical Hospital Virgen De La Arrixaca
🇪🇸
Murcia, Spain
University Hospital Virgen Del Rocio S.L.
🇪🇸
Sevilla, Spain
Hospital Universitari Vall D Hebron
🇪🇸
Barcelona, Spain
Fakultni Nemocnice Hradec Kralove
🇨🇿
Novy Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava
🇨🇿
Poruba, Czechia
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Institut Catala D'oncologia
🇪🇸L'hospitalet De Llobregat, Spain
Ana Maria Sureda Balari
Site contact
+34932607733
asureda@iconcologia.net