Trials Sponsors Conditions Drugs Pricing

Conditions

elderly patients (> 70 years) with CLL or SLL

Outcome Measures

Primary Outcomes (1)

PFS at 1 year post-ACA discontinuation is defined as the time from randomization to progression (needing therapy or not) or death from any cause. Patients alive and progression-free will be censored at the last disease assessment or at initiation of next treatment. Progression will be evaluated using iwCLL 2018 criteria

Secondary Outcomes (5)

OS is defined as the time from randomization to death from any cause. Patients alive will be censored at last follow-up news.
TTNT is defined as the time from randomization to initiation of next treatment required for symptomatic CLL. Patients without initiation of next treatment will be censored at last follow-up date. This need for restarting therapy will be centrally validated by an independent board review and based on iwCLL 2018 criteria for symptomatic CLL.
QoL will be evaluated using the EORTC QLQ-C30 questionnaire
Secondary end point (English)
Overall Response Rate (ORR) to re-treatment is defined as the proportion of re-treated patients who achieved best response of complete remission (CR), complete remission with incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per iwCLL 2018 criteria.

Interventions

Calquence 100 mg hard capsulesType not reported

Calquence 100 mg film-coated tabletsType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Calquence 100 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Calquence 100 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Calquence 100 mg hard capsules
Named ingredient: acalabrutinib
View registry record
Calquence 100 mg film-coated tablets
Named ingredient: acalabrutinib
View registry record

Eligibility Criteria

Sexall

Age GroupsOlder Adult (65+)

You may qualify if:

Age > 70 years or older
ECOG performance status ≤ 2
Previously untreated CLL or SLL

Sponsors & Collaborators

French Innovative Leukemia Organization
Type not reportedlead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (29)

Centre Hospitalier Universitaire De Montpellier

Montpellier Cedex 5, 34295, France

Emmanuelle TCHERNONOG0467332412 e-tchernonog@chu-montpellier.fr

Oncopole Claudius Regaud

Toulouse Cedex 9, 31059, France

Loïc YSEBAERT0531156351 ysebaert.loic@iuct-oncopole.fr

Centre Hospitalier Universitaire D'Angers

Angers, 49100, France

Aline CLAVERT0241355880

Central Study Contacts

Secrétariat FILO

0247391896 secretariat@filo-leucemie.org

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

September 2, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-513936-80-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:06:02 UTC

Documents

D1_ Protocol_2024-513936-80-00_Pub

You may not qualify if:

Hypersensitivity to the active substance
Known HIV seropositivity
Patients treated by vitamin K antagonist or dual anti-platelet therapy
History of bleeding diathesis (e.g. hemophilia or von Willebrand disease)
History of confirmed progressive multifocal leukoencephalopathy (PML).
Concurrent severe diseases which exclude the administration of therapy: 1). Heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial infarction within the past 6 months prior to study. 2). Significant cardiovascular disease such as symptomatic arrhythmias (including atrial fibrillation), congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study). 3). Severe chronic obstructive lung disease with hypoxemia. 4). History of stroke or intra-cranial hemorrhage within the last 6 months. 5). Severe diabetes mellitus. 6).Uncontrolled hypertension 7). Impaired renal function with creatinine clearance < 30 ml/min according the formula of Cockroft and Gault. 8). Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) unless of separate dosing of acalabrutinib capsules with antacids by at least 2 hours. Acalabrutinib capsules should be taken 2 hours before an H2-receptor antagonist. Avoid co-administration of acalabrutinib capsules with proton pump inhibitors. 9). Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection). 10). Evidence for Richter syndrome. 11). Treatment with any of the following within 7 days prior to the first dose of study drug : steroid therapy for anti-neoplastic intent. 12). A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the patient’s participation in this study or interpretation of study outcomes. 13). Major surgery within 30 days prior to the first dose of study treatment. 14). History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following: - curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study; - other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥ 5 years without further treatment
Adult under law-control
Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
No affiliation to social security
Patient under psychiatric care
Patient unable to express consent

FILOCLL14 - STAIR : "Open-label, phase 2 study investigating the STop and restart Acalabrutinib In fRrail patients with previously untreated CLL (STAIR)"

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations