2024-514122-23-00
Active, not recruiting
Phase 2
Phase II trial of acalabrutinib in combination with tafasitamab in patients with previously treated marginal zone lymphomas (MZL)
Association International Extranodal Lymphoma Study Group (IELSG)8 sites in 2 countries22 target enrollmentStarted: July 22, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 22
- Locations
- 8
- Primary Endpoint
- Complete response rate (CR) as best response to treatment, defined according to the international Revised Response Criteria for Malignant Lymphoma . For patients with SMZL, response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas, histological response is evaluated according to GELA scoring system
Overview
Brief Summary
To determine the efficacy of tafasitamab in combination with acalabrutinib in patients with relapsed or refractory MZL
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ability to understand and willingness to sign a written informed consent
- •Adequate kidney and liver function
- •Adequate coagulation parameters
- •Women with childbearing potential who are using highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and for at least 3 months after the last IMP dose
- •Men who agree not to father a child during trial treatment and for at least 3 months after the last IMP dose
- •Patient able and willing to swallow trial drugs as whole capsule
- •Histologically confirmed diagnosis of MZL
- •Disease refractory to or in first or greater relapse after prior systemic therapy
- •In need of treatment disease satisfying the following criteria: • EMZL: symptomatic lymphoma or with other treatment indications (overt progression, deep invasion, bulky disease, impending organ damage, patient preference), symptomatic disseminated disease, contraindications to radiotherapy (RT), failure after antibiotics or after local therapy, • SMZL: presence of progressive or symptomatic splenomegaly and/ or any progressive cytopaenias, • NMZL: B symptoms, deterioration of peripheral blood counts due to lymphoma infiltration of the bone marrow, rapid enlargement of lymph nodes or compression of vital organs by bulky disease
- •Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
Exclusion Criteria
- •History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following: a. Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study, b. Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥3 years without further treatment
- •Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML)
- •Concomitant diseases that require anticoagulant therapy with warfarin or phenoprocoumon or other vitamin K antagonists and patients treated with dual anti-platelet therapy
- •Malabsorption syndrome or other condition that precludes enteral route of administration
- •Known hypersensitivity to trial drugs or to any component of the trial drugs
- •Concomitant treatment with strong CYP3A inducers or inhibitors
- •Treatment with proton pump inhibitors. Subjects receiving proton pump inhibitors who switch to antacids are eligible for enrollment to this study
- •Concurrent participation in another therapeutic clinical trial
- •History of or ongoing confirmed central nervous system (CNS) lymphoma
- •Patients who received any IMP within 30 days or 5 half-lives (whichever is shorter) before the first dose of the study IMP
Outcomes
Primary Outcomes
Complete response rate (CR) as best response to treatment, defined according to the international Revised Response Criteria for Malignant Lymphoma . For patients with SMZL, response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas, histological response is evaluated according to GELA scoring system
Complete response rate (CR) as best response to treatment, defined according to the international Revised Response Criteria for Malignant Lymphoma . For patients with SMZL, response is defined according to Matutes et al. 2008 and for patients with gastric lymphomas, histological response is evaluated according to GELA scoring system
Secondary Outcomes
- Adverse events type and severity according to CTCAE v5.0 and relationship to study treatment
- Overall response rate (ORR)
- Progression free survival (PFS)
- Duration of response (DOR)
- Overall survival (OS)
Investigators
IELSG Operations Office
Scientific
Association International Extranodal Lymphoma Study Group (IELSG)
Study Sites (8)
Loading locations...
Similar Trials
Active, not recruiting
Phase 3
A Clinical trial to compare Acalabrutinib (ACP-196) versus investigator's choice standard treatment with Bendamustine/Rituximab or Idelalisib/Rituximab alone in patients with with Relapsed or Refractory
Chronic Lymphocytic Leukemia2023-509359-15-00Acerta Pharma B.V.25
Recruiting
Phase 2
Multicenter, open-label, phase II study in patients with immunoglobulin M monoclonal gammopathy of unknown significance and Myelin Associated Glycoprotein antibodies related polyneuropathy and Zanubrutinib Treatment2023-505933-29-00University Medical Center Utrecht42
Recruiting
Not Applicable
Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in BelarusNCT07288515AstraZeneca50
Not yet recruiting
Phase 2
PreVent-ACaLL2024-511072-33-00Rigshospitalet50
Not yet recruiting
Not Applicable
A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström MacroglobulinemiaNCT07259122Institute of Hematology & Blood Diseases Hospital, China43