Etude : VERLEN /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : VERLEN

Situation thérapeutique : Induction

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 04/05/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude ouverte de phase 2, évaluant l'efficacité du Lénalidomide combiné au Tafasitamab associés au Rituximab en 1ère ligne de traitement chez les patients présentant un lymphome diffus à grnades cellules B âgés de 80 ans et plus

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C83 - Lymphome non folliculaire
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study is an open-label, multi-centric, phase II study designed to evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria.

After a screening phase, eligible patients will be enrolled and start the prephase treatment with vincristine and prednisone before day 1 of cycle 1 of the experimental drugs.

Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (R-miniCHOP) at Investigator's discretion and will remain in the study.

Single group assignment:
- Experimental: R-Lena-Tafa
12 cycles of 28 days. From C1 to C6 : rituximab + tafasitamab + lenalidomide and from C7 to C12: tafasitamab and lenalidomide
* Tafasitamab: IV at 12mg/Kg C1 to C3: D1, D8, D15, D22 C4 to C6: D1, D15 C7 to C12: D1
* Lenalidomide: Oral administration: hard capsule C1 to C6: 20mg/day C7 to C12: 15mg/day
* Rituximab: IV at 375mg/m2 C1 to C6: D1

Patients with Progressive Disease or Stable Disease after 3 cycles should start a conventional chemotherapy (rituximab + cyclophosphamide + adriamycine + vincristine + prednisone R-miniCHOP) at Investigator's discretion according to local practices.

Current primary outcome:
Overall Response Rate (ORR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]

Current secondary outcome:
- Number of Serious Adverse Events (SAE) of patients treated with lenalidomide and tafasitamab [ Time Frame: 13 months ]
- Number of SAE of patients who switched to RminiCHOP [ Time Frame: 7 months ]
- Progression free survival (PFS) [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 2 years ]
- Overall Response Rate (ORR) by central assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
- Complete Metabolic Response (CMR) by local assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
- Complete Metabolic Response (CMR) by central assessment [ Time Frame: 3 months (3 cycles of 28 days) ]
- Complete Metabolic Response (CMR) by local assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
- Complete Metabolic Response (CMR) by central assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
- Complete Metabolic Response (CMR) by local assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
- Complete Metabolic Response (CMR) by central assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
- Overall Response Rate (ORR) by local assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
- Overall Response Rate (ORR) by central assessment [ Time Frame: 6 months (6 cycles of 28 days) ]
- Overall Response Rate (ORR) by local assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
- Overall Response Rate (ORR) by central assessment [ Time Frame: 12 months (12 cycles of 28 days = end of treatment) ]
- Progression free survival (PFS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]
- Overall survival (OS) of patients who switched to RminiCHOP [ Time Frame: 3 years ]

Phase : II

Stade : NA

1 (hémato)
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 1. Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all International Prognostic Index (IPI).
2. May also be enrolled the following malignancies:
* De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow or lymph node.
* High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
* High-grade B-cell lymphoma, Not Otherwise Specified (NOS)
* Follicular lymphoma grade 3B
3.Positron-Emission Tomography (PET)-positive disease
4.Previously untreated high-grade B-cell lymphoma
5.Aged ≥ 80 years old at the time of signing the informed consent form (ICF)
6.Ann Arbor stage I, II, III or IV
7.Eastern Cooperative Oncology Group (ECO)G performance status ≤ 2
8.With a minimum life expectancy of 3 months
9.Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 4 months following study drug discontinuation, even if they have undergone a successful vasectomy
10. Patients should be able to receive R-miniCHOP regimen (left ventricular ejection fraction > 50% and good general condition, according to investigator's judgment)
11. Patients should be able to receive adequate prophylaxis and/or therapy for thromboembolic events (aspirin or low molecular weight heparin)
12. Patient covered by any social security system (France)

Critères de non-inclusion : 1. Any other histological type of lymphoma, Burkitt included
2. Any history of treated or non-treated Small-B cell lymphoma prior Aggressive B Cell lymphoma diagnosis
3. Central nervous system or meningeal involvement by lymphoma
4. Any serious active disease (according to the investigator's decision)
5. Poor renal function (calculated Cockcroft-Gault creatinine clearance < 30 ml/min)
6. Poor hepatic function (total bilirubin level >30 μmol/l, transaminases >2.5 upper normal limits) unless these abnormalities are related to lymphoma
7. Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration by lymphoma cells (Bone Marrow Aspiration will be mandatory in case of severe cytopenias prior inclusion)
8. Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
9. Treatment with any investigational drug within 30 days prior to prephase treatment and during the study
10. Known HIV, active Hepatitis C Virus (HCV) infection or positive Hepatitis B Virus (HBV) test within 4 weeks before enrollment (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
11. Prior treatment with anti-CD20/anti-CD19 monoclonal antibody or alemtuzumab within 3 months prior to prephase treatment
12. Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide
13. Contra-indication to highly dosed glucocorticoid (60 mg/m2/d)
14. Neuropathy ≥ Grade 2 or painful
15. Patient deprived of his/her liberty by a judicial or administrative decision
16. Adult patient under legal protection
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04974216
Promoteur :
lysarc
Type de sponsor : Institutionnel
Centre hospitalier Lyon sud, secteur sainte Eugénie, pavillon 6E
69001 LYON 01

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Franck MORSCHHAUSER

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 20/12/2021