Study of Acalabrutinib and Tafasitamab in MZL Patients

Sponsor
International Extranodal Lymphoma Study Group (IELSG)
Study ID
NCT04646395
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tafasitamab — DRUG
    200 mg powder for reconstitution with 5 ml water for injection
  • Acalabrutinib — DRUG
    100 mg hard gelatin capsules

Study Details

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. .

Key Dates

Start date
Oct 20, 2021
Status verified
Mar 2026
Primary completion
Sep 15, 2027
Completion
Mar 15, 2028

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tafasitamab and Acalabrutinib
    Acalabrutinib will be administered continuously at the dose of 100 mg BID (equivalent to a total daily dose of 200 mg), from day 1 to day 28 of each cycle for 24 cycles. Tafasitamab will be administered 12 mg/kg iv on days 1, 8, 15 and 22 for the first 3 cycles. Then patients will continue treatment until cycle 24 with tafasitamab 12mg/kg iv on day 1

Primary Outcome Measure

Complete Response (CR) Rate as best response to treatment [ Time Frame: Between 11 - 13 weeks after treatment start, at the end of cycles 6, 12, 18, 24 (each cycle is 28 days) ]

Related Studies