Study of Acalabrutinib and Tafasitamab in MZL Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Marginal Zone Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Marginal zone B cell lymphomas (MZLs) comprise three distinct entities: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue type (MALT) lymphoma, splenic MZL (SMZL) and nodal MZL (NMZL). Together they represent approximately 5%-15% of all non-Hodgkin lymphomas. MZL are in general indolent lym...
Marginal zone B cell lymphomas (MZLs) comprise three distinct entities: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue type (MALT) lymphoma, splenic MZL (SMZL) and nodal MZL (NMZL). Together they represent approximately 5%-15% of all non-Hodgkin lymphomas. MZL are in general indolent lymphomas with relatively low risk of transformation. The available treatment options can lead to responses but disease recurrence is often observed. For patients with MZL and recurrent disease following initial treatment, currently there is no established standard therapy and new treatment options and treatment combinations are needed. The proposed trial will evaluate the safety and efficacy of the anti-CD19 monoclonal antibody tafasitamab in combination with the BTK inhibitor acalabrutinib. The B-lymphocyte, lineage specific surface antigen CD19 is broadly and homogeneously expressed in MZLs. This makes CD19 an attractive target for the treatment of MZL patients, in particular those who failed a previous rituximab-containing regimen. On the other hand, genetic and immunogenetic data point to B-cell receptor signalling as a key oncogenic pathway of MZLs. The activity of single agent ibrutinib in MZLs is an in vivo proof that MZLs are addicted of BTK-driven signalling and that the BCR pathway is a vulnerability of these lymphomas. The safety profile of the anti CD19 monoclonal antibody tafasitamab and of the BTK inhibitor acalabrutinib indicate the possibility that their combination can be developed without major overlapping side effects. The proposed trial is a prospective multicenter trial combining tafasitamab and acalabrutinib in patients with MZL (including EMZL, SMZL and NMZL) with disease refractory to or in first or greater relapse after prior systemic therapy.
Tracking Information
- NCT #
- NCT04646395
- Collaborators
- Not Provided
- Investigators
- Study Chair: Anastasios Stathis, MD Oncology Institute of Southern Switzerland - Bellinzona, Switzerland Study Chair: Davide Rossi, MD Oncology Institute of Southern Switzerland - Bellinzona, CH Study Chair: Emanuele Zucca, MD Oncology Institute of Southern Switzerland - Bellinzona, CH