A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed/refracTory Follicular Lymphoma Patients (MOZART)

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R/R FL who have received at least one line of prior systemic therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.

• Histologically documented diagnosis of cFL (CD20+ by flow cytometry or immunohistochemistry) as defined in the International Consensus Classification of Mature Lymphoid Neoplasms (Campo E., 2022) and in the World Health Organization Classification (WHO) 5th edition 2022.

• Age ≥18 years.

• Relapsed or refractory disease. Histologic confirmation of FL relapse is not mandatory but is highly recommended.

• At least one and up to three lines of systemic therapy containing an anti-CD20 antibody (anti-CD20 alone and/or in combination with radiotherapy is not considered as a line of therapy).

• FL requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.

• Availability of histological material for centralized revision. Central pathology review is not mandatory for start of treatment.

• At least one measurable or evaluable site of disease at relapse as documented by CT scan (nodes ≥ 1.5 cm in the longest transverse diameter) or FDG-PET (avid FDG sites). Note: MRI is allowed only if CT scan cannot be performed. Patients with exclusive bone marrow involvement are eligible.

⁃ Adequate hematological counts defined as follows:

∙ Absolute neutrophil count (ANC) \> 1.0 x 109/L;

‣ Platelet count ≥ 75 x 109/L;

‣ Hemoglobin ≥ 9 g/dL.

⁃ Adequate renal function defined as creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula, normalized to 1.72 m2).

⁃ Adequate hepatic function per local laboratory reference range as follows:

∙ Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN;

‣ Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).

⁃ Subject must be able to adhere to the study visit schedule and other protocol requirements.

⁃ Subject must be able to swallow capsules or tablets.

⁃ Women must be:

∙ postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months);

‣ surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy);

‣ if they are childbearing potential, completely abstinent (periodic abstinence is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization), before entry, and must agree to continue to use the same method of contraception throughout the study and for 30 days after receiving the last dose of zanubrutinib and 3 months after receiving the last dose of mosunetuzumab.

⁃ Women of childbearing potential must have a negative pregnancy test at screening.

⁃ Men must agree to use an acceptable method of contraception for the duration of the study and for 1 week after receiving the last dose of study drug.

⁃ Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following:

∙ practice effective barrier contraception (e.g.: condoms) , or

‣ agree to practice abstinence, when this is in line with the usual lifestyle of the subject (periodic abstinence is not permitted).

Locations
Other Locations
Australia
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
St. Vincent Hospital Melbourne
NOT_YET_RECRUITING
Melbourne
Princess Alexandra Hospital
NOT_YET_RECRUITING
Woolloongabba
Italy
AOU SS. Antonio e Biagio e Cesare Arrigo, SCDU Ematologia
RECRUITING
Alessandria
AOU Ospedali Riuniti, Clinica di Ematologia
RECRUITING
Ancona
Azienda Ospedaliera S.Giuseppe Moscati, S.C. Ematologia e Trapianto emopoietico
RECRUITING
Avellino
IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia
RECRUITING
Bari
Policlinico S.Orsola-Malpighi, Istituto di Ematologia Seragnoli
RECRUITING
Bologna
ASST Spedali Civili di Brescia, Ematologia
RECRUITING
Brescia
Fondazione del Piemonte per l'Oncologia - IRCCS, Ematologia
RECRUITING
Candiolo
Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia
RECRUITING
Catania
Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia
RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori, Ematologia
RECRUITING
Monza
AOU Maggiore della Carità di Novara, SCDU Ematologia
RECRUITING
Novara
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
RECRUITING
Palermo
Azienda USL Piacenza, UOC Ematologia e Centro Trapianti
RECRUITING
Piacenza
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
RECRUITING
Reggio Emilia
Ospedale degli Infermi di Rimini, U.O. di Ematologia
RECRUITING
Rimini
Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione
RECRUITING
Roma
A.O.U. Città della Salute e della Scienza di Torino, S.C.Ematologia
NOT_YET_RECRUITING
Torino
Ospedale Ca' Foncello, S.C di Ematologia
RECRUITING
Treviso
Contact Information
Primary
Uffici Studi FIL
startup@filinf.it
+390131033153
Backup
Uffici Studi FIL
gestionestudi@filinf.it
+390599769913
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2033-09-15
Participants
Target number of participants: 56
Treatments
Experimental: Mosunetuzumab in combination with Zanubrutinib
Pre-phase: Zanubrutinib 320 mg daily by mouth (D-15 to D-1)~Induction phase cycle 1 (Q21 days):~* Zanubrutinib 320 mg daily by mouth (D1-21)~* Mosunetuzumab 5 mg, SC (D1)~* Mosunetuzumab 45 mg, SC (D8)~* Mosunetuzumab 45 mg, SC (D15)~Induction phase cycles 2-12 (Q28 days):~* Zanubrutinib 320 mg daily by mouth (D1-28)~* Mosunetuzumab 45 mg, SC (D1)~Maintenance phase cycles 13-24 (Q28 days): Zanubrutinib 320 mg daily by mouth (D1-28)~Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events.
Sponsors
Leads: Fondazione Italiana Linfomi - ETS

This content was sourced from clinicaltrials.gov