Health TrialsbyHealthPanel

Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients

ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Histological diagnosis different from cFL (Campo E., 2022).

R/R FL who were treated with more than three lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy; rituximab maintenance as part of a previous line of therapy should not be considered as a line of therapy; radiotherapy alone or in combination with rituximab is not considered a line of therapy).

Patients with stage I or II (limited stage) suitable for RT alone treatment.

Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor (BTKi).

Trial design

Design model

Single group

Treatments tested in this trial

  • Mosunetuzumab in combination with Zanubrutinib

    Drug

    Combinations of Mosunetuzumab and Zanubrutinib as salvage strategy in patients with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Mosunetuzumab in combination with ZanubrutinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response Rate (CRR)

CRR at the end of the induction therapy

Time frame
36 months

Secondary outcomes

1

Overall Response Rate (ORR), Partial Response (PR) Rate at the end of induction treatment (EOI)

ORR and PR Rate at the end of induction treatment (EOI)

Time frame
36 months
2

Overall Response Rate (ORR), Partial Response (PR) Rate at the end of maintenance (EOT, end of treatment)

ORR and PR Rate at the end of maintenance (EOT, end of treatment)

Time frame
48 months
3

Progression Free Survival (PFS)

PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death from any cause.

Time frame
108 months
4

Overall Survival (OS)

OS defined as the time between the start of prephase and death from any cause.

Time frame
108 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Italiana Linfomi - ETS

Lead sponsor

Source ClinicalTrials.gov
Apply now