EUCTR2020-003946-36-IT进行中（未招募）1 期
Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •REFER TO PROTOCOL FOR FULL LIST
- •1.Adults =18 years old.
- •2.Patient populations:
- •a) For Phase 1 Dose Escalation:
- •aNHL including mantle cell lymphoma and DLBCL histologies such as transformed DLBCL from low-grade lymphoma (follicular or others), DLBCL associated with small-cell infiltration in bone marrow, B-cell lymphoma with intermediate features between DLBCL and Burkitt’s lymphoma or with intermediate features between DLBCL and Hodgkin lymphoma, FL Grade 3B, and aggressive B-cell lymphoma unclassifiable who must have previously received rituximab, cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine (Oncovin®) and prednisone (R-CHOP) (or equivalent anti-CD20 containing therapy) and 1 additional line of therapy in the r/r setting.
- •iNHL (including FL of grades 1–3A and marginal zone lymphoma) refractory to rituximab or to any other anti-CD20 monoclonal antibody, who have received at least 1 prior systemic therapy for r/r iNHL:
- •oRituximab or anti-CD20 refractoriness is defined as failure to respond to, or progression during, any previous rituximab/anti-CD20-containing regimen (monotherapy or combined with chemotherapy), or progression within 6 months of the last rituximab or anti-CD20 dose.
- •NOTE: The minimum qualifying rituximab/anti-CD20 dose is 1 full cycle (ie, weekly x 4 doses monotherapy or 1 complete dose if combined with chemotherapy). Prior anti-CD20 antibody or cytotoxic drugs may have been administered as single agents or as components of combination therapies. Each repeated course of the same single agent or combination is considered an independent regimen.
- •b) For Phase 2, the following CD20 positive:
- •r/r DLBCL progressed or relapsed after a prior CAR T-cell therapy that has received approval by a health authority for the treatment of DLBCL (Cohort A).
- •r/r DLBCL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy and has not received prior cellular therapy. At least one prior line of therapy must have included a CD20-targeted therapy (Cohort B).
- •r/r FL that has progressed or relapsed after at least 2 but no more than 3 prior lines of systemic therapy. At least one prior line of therapy must have included a CD20-targeted therapy (Cohort C).
- •3.Patients must be considered ineligible for, in the opinion of the investigator, or must have refused autologous stem-cell transplantation.
- •4.Eastern Cooperative Oncology Group performance score of =2.
- •5.Adequate bone marrow function per local laboratory reference range at screening as follows:
- •oPlatelet count =75.0 x 109/L, Grade 2 thrombocytopenia (platelet count =50.0 x 109/L) is allowed if it is clearly due to marrow involvement with no evidence of myelodysplastic syndrome or hypoplastic bone marrow if found. ANC =1.0 x 109/L. Hemoglobin =85 g/L (red blood cell transfusion allowed =14 days before assessment).
- •6.Adequate renal and hepatic function, per local laboratory reference range at screening as follows:
- •oCalculated creatinine clearance = 30 mL/min calculated with Cockcroft – Gault formula.
- •oAspartate aminotransferase and alanine aminotransferase =3.0× the upper limit of normal (ULN) of the institution’s normal range; bilirubin =1.5× ULN. Patients with Gilbert’s syndrome may have a bilirubin level >1.5× ULN, per discussion between the investigator and the Medical Monitor.
- •7.Left ventricular ejection fraction =40%; as measured by echocardiogram or multiple gated acquisition scan.
- •8.Suitable venous acce
排除标准
- •REFER TO PROTOCOL FOR FULL LIST
- •Main Criteria for Exclusion:
- •1.Central nervous system lymphoma; active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or CT scan/magnetic resonance imaging.
- •2.Hypersensitivity to TAK-981, rituximab, or any component of the drug product.
- •3.History of Grade =3 IRR that lead to permanent discontinuation of previous rituximab treatment.
- •4.Previous participation in the TAK-981-1002 clinical study.
- •5.Posttransplantation lymphoproliferative disease except relapsed NHL after autologous stem-cell transplantation.
- •6.Undergone ASCT or treatment with cellular therapy including CAR T within =3 months of TAK-981 dosing.
- •7.Prior allogeneic hematopoietic stem-cell transplantation.
- •8.Lymphomas with leukemic expression.
- •9.Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 2 weeks or within at least 5 half-lives before TAK-981 dosing, whichever is shorter. Low dose steroids (oral prednisone or equivalent =20 mg per day), hormonal therapy for prostate cancer or breast cancer (in adjuvant situation), and treatment with bisphosphonates and RANKL (receptor activator of nuclear factor kappa-B ligand) inhibitors are allowed.
- •10.Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
- •11.Significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the risk-benefit ratio of participating in the study. This includes but is not limited to acute myocardial infarction or unstable angina within the last 6 months, uncontrolled diabetes mellitus, significant active bacterial, viral, or fungal infections, severely immunocompromised state, severe non-compensated hypertension and congestive heart failure New York Heart Association Class III or IV, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
- •12.Known chronic hepatitis C and/or positive serology (unless due to vaccination or passive immunization due to immunoglobulin therapy) for chronic hepatitis B. Known HIV infection.
- •13.Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapy as defined in Exclusion Criterion 9 .
- •14.Receipt of any live vaccine within 4 weeks of initiation of study treatment.
- •15.Active, uncontrolled autoimmune disease requiring > 20 mg of prednisone or equivalent, cytotoxics, or biologicals.
- •16.Corticosteroid use within 1 week before first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. Patients requiring steroids at daily doses >20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for lymphoma control or white blood cell count lowering are not eligible.
- •17.History of medical or psychiatric illness likely to interfere with ability to comply with protocol requirements or give inf
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