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Study of Acalabrutinib and Tafasitamab in MZL Patients

NCT04646395 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-06

No results posted yet for this study

Summary

This is a multicenter open label phase II trial in patients with previously treated Marginal Zone Lymphomas.

The aim of the study is to evaluate the efficacy and the safety of tafasitamab in combination with acalabrutinib.

Twenty-four patients are expected to be enrolled and treated every 28 days with acalabrutinib and tafasitamab for 24 cycles.

The study consists of two parts, which are performed sequentially. The first part is a safety run-in to evaluate the safety data once 6 patients (representing the 25% of the total cohort) have completed the first cycle of treatment. An Independent Data Monitoring Committee (IDMC) will provide an independent assessment of this evaluation.

The second part starts after the outcome of this evaluation and will include the remaining 18 patients. The 6 patients of the safety run-in phase will be considered for the final evaluation of the study.

Between 11 - 13 weeks, patients showing partial or complete response (PR, CR) will continue treatment, while patients showing stable disease (SD) will discontinue it. However, patients in SD who benefit from therapy may continue to be treated, after agreement between the Investigator and the Sponsor.

Patients who complete the 24 cycles of treatment will enter the follow-up phase up to 3 years from patient's last study treatment dose (about 5 years from treatment start).

Patients who discontinue treatment before cycle 24 for any reason will be followed for up to 3 years (every 6 months for the first year and yearly for the second and third year) from the patient's last study treatment dose.

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Conditions

Interventions

DRUG

Tafasitamab

200 mg powder for reconstitution with 5 ml water for injection

DRUG

Acalabrutinib

100 mg hard gelatin capsules

Sponsors & Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

    lead OTHER

Principal Investigators

  • Anastasios Stathis, MD · Oncology Institute of Southern Switzerland - Bellinzona, Switzerland

  • Davide Rossi, MD · Oncology Institute of Southern Switzerland - Bellinzona, CH

  • Emanuele Zucca, MD · Oncology Institute of Southern Switzerland - Bellinzona, CH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2027-09-15
Completion
2028-03-15

Countries

  • Austria
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04646395 on ClinicalTrials.gov