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Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphoma (ALTAMIRA)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509864-96-00
Acronym
NLG-MCL8
Enrollment
80
Registered
2024-09-04
Start date
2021-12-07
Completion date
Unknown
Last updated
2024-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma (MCL)

Brief summary

Progression-free survival. This is defined as the interval between date of obtaining informed consent and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.

Detailed description

Complete response rate at 6 months, Molecular remission rate (MRR) by PCR, Overall response rate, Progression-free survival (median), Response duration (median), Duration of molecular remission (median), Overall survival (median), CR, MRR and ORR in TP53-mutated MCL, Safety, in terms of all grade 3-5 AE

Interventions

DRUGACALABRUTINIB

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival. This is defined as the interval between date of obtaining informed consent and date of documented progression, first relapse, or death of any cause. Otherwise, patients will be censored at the last date they were known to be alive.

Secondary

MeasureTime frame
Complete response rate at 6 months, Molecular remission rate (MRR) by PCR, Overall response rate, Progression-free survival (median), Response duration (median), Duration of molecular remission (median), Overall survival (median), CR, MRR and ORR in TP53-mutated MCL, Safety, in terms of all grade 3-5 AE

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026