A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL) [frontMIND] - MOR208C310

Morphosys AG0 个研究点目标入组 899 人开始时间: 2024年3月12日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Morphosys AG
入组人数: 899

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Signed written informed consent form (ICF)., Patient must have the following local laboratory criteria at screening: a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) b. Platelet count = 75 x 10^9/L (unless secondary to bone marrow involvement by DLBCL) c. Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert’s Syndrome or documented liver involvement by lymphoma. Patients with Gilbert’s Syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is = 5 × ULN d. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) = 3 × ULN, or = 5 × ULN in cases of documented liver involvement e. Serum creatinine clearance must be = 30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976), In the opinion of investigator, the patient must: a. Be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events, e.g. aspirin 75 to 325 mg per os, orally (PO) daily (81 to 325 mg PO daily in the US) or low molecular weight heparin (e.g. enoxaparin 40 mg (4,000 IU) once daily by subcutaneous (SC) injection). This is due to increased risk of thrombosis in patients treated with lenalidomide without prophylaxis. Patients unable or unwilling to take any prophylaxis are not eligible b. Be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations c. Not have a history of noncompliance in relation to medical regimens nor be considered potentially unreliable and/or uncooperative d. Be able to understand the reason for complying with the special conditions of the pregnancy prevention and in writing acknowledge to adhere to them, Due to the teratogenic potential of lenalidomide, females of childbearing potential (FCBP) must: a. Not be pregnant as confirmed by a negative serum pregnancy test at screening and a medically supervised urine pregnancy test prior to starting study therapy b. Refrain from breast feeding and donating oocytes during the course of study and for three (3) months after the last dose of study drug or according to local guidelines for R-CHOP, whichever is longer c. Agree to ongoing pregnancy testing during the course of the study and after study therapy has ended. Additionally, agree to pregnancy testing and counseling if a patient misses her period or if there is any abnormality in her menstrual bleeding. This applies even if the patient applies complete sexual abstinence d. Commit to continued abstinence from heterosexual intercourse if it is in accordance with her lifestyle (which must be reviewed on a monthly basis) or agree to use and be able to comply with the use of highly effective contraception without interruption at least four (4) weeks prior to start of study drugs, during the study treatment and for three (3) months after the last dose of study drug, or, for R-CHOP, according to the local guidelines, whichever is longer., Male participants must: a. Use an effective barrier method of contraception without interruption if the patient is sexually active with a FCBP. Male participants should refrain from donating sperm during the study participation and for three (3) months after the last dose of study drug, or according to the local guidelines for R-CHOP, whichever is longer, Adult subjects aged 18 (or legal age per lo

排除标准

•1) Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g. primary mediastinal (thymic) large B-cell lymphoma, Burkitt’s lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma., 4g) Patients with history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that, in the investigator’s opinion, would preclude participation in the study or compromise the patient’s ability to give informed consent, 4h) Patients with history or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, 4i) Patients with vaccination with live vaccine within 21 days prior to study randomization, 4j) Patients with major surgery within up to 21 days prior to signing the informed consent form (ICF), unless the patient is recovered at the time of signing the ICF, 4k) Patients with any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment, 4l) Patients with contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines, 4m) Patients with pregnancy or lactation, 4n) Patients with history of hypersensitivity to any component of R-CHOP, to lenalidomide, to compounds of similar biological or chemical composition to tafasitamab, IMiDs and/or the excipients contained in the study drug formulations, 2) History of radiation therapy to = 25% of the bone marrow for other diseases., 3) History of prior non-hematologic malignancy except for the following: a. Malignancy treated with curative intent and with no evidence of active disease present for more than two (2) years before screening b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer. c. Adequately treated carcinoma in situ without current evidence of disease., 4a) Patients with positive local test result during screening for hepatitis C (hepatitis C virus [HCV] antibody serology testing) and a positive test for HCV RNA. Patients with positive serology must have been tested locally for HCV RNA and are eligible, in case of negative HCV RNA test results, 4b) Patients with positive local test result during screening for chronic hepatitis B virus (HBV) infection (defined by hepatitis B surface antigen [HBsAg] positivity). Patients with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody [HBcAb]) may be included if HBV DNA was undetectable (local test result), provided that they are willing to undergo ongoing DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible, 4c) Patients with Seropositive (local test during screening) for, or history of active viral infection with human immunodeficiency virus (HIV), 4d) Patients with known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay). Antiviral or antibacterial prophylaxis may be administered as per institutional guidelines, 4e) Patients with positive

研究者

发起方

Morphosys AG

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