2026-525763-40-00Not yet recruitingPhase 2
FILOCLL017 - NEVOTAL : Nemtabrutinib in addition to Venetoclax-Obinutuzumab in chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL) patients with TP53 ALterations
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Sept 2026
Brief summary (registry, in English)
The primary objective of the study is to determine the efficacy of the nemtabrutinib-VO (NVO) regimen at day 1 cycle 16, which corresponds to the completion of 15 cycles of nemtabrutinib, 12 cycles of venetoclax and 6 cycles of obinutuzumab.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- 1 Dec 2026
- Lead sponsor
- French Innovative Leukemia Organization (F.I.L.O.).
- Diseases
- Chronic lymphocytic leukaemia
- EU CT number
- 2026-525763-40-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have not been treated before, need treatment, and have TP53 changes.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- CLL or SLL that needs treatment under iwCLL 2018 criteria, with at least 1 sign of disease burden: enlarged lymph nodes over 1.5 cm, lymphocyte count over 4 x 10^9/L, platelet count under 100 x 10^9/L, or hemoglobin under 11 g/dL. ECOG performance status of 0 to 2.
- Earlier treatment
- No earlier treatment for CLL or SLL.
- Biomarker or test result
- TP53 changes: 17p deletion (by FISH and/or CBA) or TP53 mutation, with a positivity threshold of 1% of abnormal cells.
Main reasons for not taking part
- Active uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Active involvement of the central nervous system (CNS)
- Uncontrolled heart or blood vessel disease, heart attack within 6 months, or certain ECG changes (QTcF over 450 msecs)
- Current treatment with P-gp substrates with a narrow therapeutic index, strong CYP3A inducers or strong CYP3A inhibitors
- Any condition or test result that could confound the results of the study or interfere with taking part, in the investigator's opinion
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently being treated with the following drugs: a. P-gp substrates with a narrow therapeutic index; b. CYP3A strong inducers; c. CYP3A strong inhibitors.
Other illness
- Active uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
Lab values
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to inclusion, or QTc prolongation (defined as a QTcF >450 msecs) or other significant ECG abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min). Correction of suspected drug-induced QTcF prolongation can be attempted at the Investigator’s discretion and only if clinically safe to do so.
Other
- Active CNS involvement.
Who the study is looking for
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) / small lymphocytic leukemia (SLL) requiring therapy according to iwCLL 2018 criteria
- At least 1 of the following markers of disease burden: (i) malignant lymph nodes attributable to CLL/SLL, which are clearly and reproducibly measurable in 2 dimensions in the axial plane, and measure >1.5 cm in longest diameter when assessed by CT/MRI scan; (ii) absolute lymphocyte count > 4 x 10^9/L; (iii) platelet count <100 x 10^9/L; (iv) hemoglobin <11 g/dL.
- Presence of TP53 abnormalities (either 17p deletion by fluorescence in situ hybridization [FISH] and/or chromosome banding array [CBA] or TP53 mutations), whatever is the percentage of abnormal cells with a positivity threshold of 1%.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- Adequate organ function
- Ability to understand the purpose and risks of the study and provide signed and dated informed
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Not yet recruiting |
| Centre Hospitalier Victor Dupouy | Argenteuil Cedex | France | Not yet recruiting |
| Centre Hospitalier d'Avignon | Avignon | France | Not yet recruiting |
| Centre Hospitalier de la Cote Basque | Bayonne | France | Not yet recruiting |
| CHU Besançon | Besançon | France | Not yet recruiting |
| Institut Bergonie | Bordeaux | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand | Clermont-Ferrand | France | Not yet recruiting |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | Not yet recruiting |
| CHU Henri Mondor | Créteil Cedex | France | Not yet recruiting |
| Centre Hospitalier Annecy Genevois | Epagny Metz-tessy | France | Not yet recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier De Versailles | Le Chesnay Rocquencourt | France | Not yet recruiting |
| Chorale Du Centre Hospitalier De Lens | Lens | France | Not yet recruiting |
| Centre Hospitalier De Libourne Robert Boulin | Libourne | France | Not yet recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Et Universitaire de Limoges | Limoges | France | Not yet recruiting |
| Centre De Recherche En Cancerologie De Lyon | Lyon | France | Not yet recruiting |
| Groupe Hospitalier de la Région de Mulhouse et Sud Alsace | Mulhouse | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Nimes | Nimes Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Universitaire d'Orléans | ORLEANS | France | Not yet recruiting |
| APHP - Hôpital Universitaire Pitié-Salpêtrière | PARIS | France | Not yet recruiting |
| Centre Hospitalier De Perpignan | Perpignan Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire Reims | Reims Cedex | France | Not yet recruiting |
| Centre Henri Becquerel | Rouen | France | Not yet recruiting |
| Centre Hospitalier De Saint-Brieuc | Saint-Brieuc | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Not yet recruiting |
| Centre Hospitalier Valence | Valence | France | Not yet recruiting |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Not yet recruiting |
| Centre Hospitalier Bretagne Atlantique | Vannes | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.