EUCTR2020-002990-84-RO进行中（未招募）1 期
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
适应症
相关药物
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
- 880
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
- •1. Written informed consent.
- •2. Age 18 to 80 years at time of signing of the ICF.
- •3. Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:
- •a. DLBCL, NOS including GCB type, ABC type
- •b. T-cell rich large BCL
- •c. Epstein-Barr virus-positive DLBCL, NOS
- •d. Anaplastic lymphoma kinase (ALK)-positive large BCL
- •e. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
- •f. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma).
- •g. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
- •h. FL grade 3b
- •4. Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review.
- •5. Up to six of the largest target nodes, nodal masses, or other lymphomatous lesions that are measurable in two diameters should be identified by local assessment from different body regions representative of the patient’s overall disease burden and include mediastinal and retroperitoneal disease, if involved. 6. ECOG performance status of 0, 1, or 2.
- •7. IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients = 60 years of age).
- •8. Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing lymphoma according to the local pathology report) and the start of treatment (C1D1) = 28 days.
- •9. Left ventricular ejection fraction equal to or greater than lower limit of institutional normal range, assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
- •10. Patient must have the following local laboratory criteria at screening:
- •a. Absolute neutrophil count (ANC) = 1.5 x 109/L (unless secondary to bone marrow involvement by DLBCL)
- •b. Platelet count = 75 x 109/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)
- •11. 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 70 to 325 mg daily or low molecular weight heparin.
- •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 risk management plan and in writing acknowledge to adhere to this plan
- •12. Due to the teratogenic potential of lenalidomide, females of childbearing potential (FCBP) must:
- •a. Not be pregnant as confirmed by a neg
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.
- •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 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
- •4. Patients with:
- •a. 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
- •b. 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 is undetectable (local test result), provided that they are willing to undergo ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible
- •c. Seropositive (local test result during screening) for, or history of active viral infection with human immunodeficiency virus (HIV)
- •d. 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)
- •e. Positive results for the human T-lymphotrophic 1 virus (HTLV-1). HTLV testing during screening is required for patients at sites in endemic countries (Japan and Melanesia and countries in the Caribbean basin, South America, Central America, and sub-Saharan Africa)
- •f. Known CNS lymphoma involvement
- •g. 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
- •h. History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •i. Vaccination with live vaccine within 21 days prior to study randomization
- •j. 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
- •k. Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
- •l. Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
- •m. Pregnancy or lactation
- •n. History of hypersensitivity to any component of R-CHOP, to lenalidomide, to compounds of similar biological or chem
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