Clinical study of acalabrutinib and tafasitamab in previously treated marginal zone lymphoma

Phase 1

• Conditions: Marginal Zone Lymphomas refractory to or in first or greater relapse after prior systemic therapy; MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004396-38-AT
• Lead Sponsor: IELSG - International Extranodal Lymphoma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-13
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Ability to understand and willingness to sign a written informed
consent
- 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).
- Ann Arbor Stage I-IV (Appendix A).
- ECOG performance status of 0, 1 or 2.
- Age = 18 years.
- Absolute neutrophil count (ANC) = 1.000/mm3 and platelets =100.000/mm3, unless these abnormalities are related to bone marrow infiltration or to hypersplenism.
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

- Patients with a prior malignancy and treated with curative intention, unless all treatments of that malignancy were completed at least 2 years before registration and the patient has no evidence of disease at registration.
- Major surgery and any systemic anti-cancer treatment within 3 weeks prior to registration.
- Prior exposure to a BTK inhibitor or CD19-targeted therapy.
- Steroid therapy for anti-neoplastic intent.
- Severe or uncontrolled cardiovascular diseases
- History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration and known bleeding disorders (e.g., von Willebrand’s disease or hemophilia).
- 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.
- Any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
Active human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection. Patients positive for hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA;
- Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or equivalent.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified