EUCTR2021-003855-40-ES进行中（未招募）1 期
A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) (MINDway) - MINDway
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
- 51
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. Capable of giving signed informed consent as described in Appendix 2: Regulatory, Ethical, and Trial Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •2. Patient must be 18 - 80 years of age (18 – 70 for Czech republic) at the time of signing the informed consent.
- •3. One of the following histologically confirmed diagnoses:
- •DLBCL not otherwise specified (NOS)
- •T cell/histiocyte-rich large B-cell lymphoma (THRLBCL)
- •Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL)
- •Grade 3b Follicular Lymphoma
- •Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification.
- •Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low-grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
- •4. Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study. If archival paraffin embedded tumor tissue acquired =3 years prior to screening is not available, a fresh tumor tissue sample from the patient should be obtained.
- •5. Patients must have:
- •a. Relapsed and/or refractory disease as defined in Appendix 3: Study Specific Definitions Appendix
- •b. At least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of = 1.5 cm and greatest perpendicular diameter of = 1.0 cm at baseline. The lesion must be positive on positron emission tomography (PET) scan (for definition see Juweid et al., 2007)
- •c. Received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a cluster of differentiation-20 (CD20)-targeted therapy (e.g., rituximab [RTX])
- •d. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- •6. Patients that are not eligible, or patients unwilling to undergo intensive salvage therapy including autologous stem cell transplantation (ASCT). The reason for a patient’s ineligibility must meet one of the criteria described below and documented in the patient’s source data:
- •a. Inadequate performance status (Karnofsky performance status = 80%; see Appendix 5: Karnofsky Performance Status Scale)
- •b. Disease not responsive to salvage chemotherapy. Responsiveness is defined as a tumor demonstrating either complete response (CR) or partial response (PR) to salvage chemotherapy
- •c. Inadequate major organ function (any of the below):
- •i. symptomatic congestive heart failure
- •ii. lung function-forced vital capacity (FVC), forced expiratory volume in 1 second (FEV-1), and corrected diffusion capacity of the lung for carbon monoxide (DLCO) = 60%
- •iii. liver function-total serum bilirubin and transaminases > 2 x upper limit of normal (ULN)
- •d. History or evidence of significant co-morbid medical or psychiatric illness which would significantly compromise the patient's clinical care and chances of survival
- •e. Inability to collect adequate stem cell graft (e.g. < 1–2 x 106 CD34+ cells free of tumor contamination/kg recipient body weight)
- •7. Patients must meet the following laboratory criteria at screening:
- •a. Absolute neutrophil count (ANC) = 1.5 × 109/L (unless s
排除标准
- •1. General provisions:
- •a. Patients who are legally institutionalized, or patients under judicial protection
- •b. Concurrent enrollment in another interventional clinical study
- •2. Patients who have:
- •a. Any other histological type of lymphoma including primary mediastinal (thymic) large B-cell (PMBL) or Burkitt lymphoma
- •b. Primary refractory DLBCL
- •c. Known double/triple hit genetics (high grade B-cell lymphoma) characterized by simultaneous detection of MYC with BCL2 and/or BCL6 translocation(s). MYC, BCL2, BCL6 testing prior to study enrollment is not required
- •3. Patients who have, within 14 days prior to Day 1 dosing:
- •a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
- •b. Undergone major surgery (within 4 wks) or suffered from significant traumatic injury
- •c. Received live vaccines
- •d. Required parenteral antimicrobial therapy for active, intercurrent infections
- •4. Patients who:
- •a. Have not recovered sufficiently from the adverse toxic effects of prior therapies
- •b. Were previously treated with CD19-targeted therapy or IMiDs® (e.g., thalidomide, LEN)
- •c. Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs® and/or the excipients contained in the study treatment formulations
- •d. Have undergone ASCT within the period = 3 months prior to signing the ICF. Patients with distant history of ASCT must exhibit full hematological recovery before enrolment
- •e. Have undergone previous allogenic stem cell transplantation
- •f. Have a history of DVT/embolism, threatening thromboembolism or known thrombophilia or at high risk for a thromboembolic event & who are not willing to take VTE prophylaxis during the entire treatment period
- •g. Concurrently use other anticancer or experimental treatments
- •5. History of other malignancy that could affect protocol compliance or interpretation of results. Exceptions:
- •a. Any malignancy treated with curative intent and malignancy in remission without treatment for > 2 years prior to enrollment are eligible
- •b. Low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
- •6. Patients with:
- •a. Positive hepatitis B and/or C serology
- •b. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
- •c. CNS lymphoma involvement – present or past medical history
- •d. History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that precludes participation in study or compromises ability to give informed consent
- •e. History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •f. GI abnormalities (absorption issues) including inability to take oral medication
- •g. History or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL), jaundice unless secondary to Gilbert’s syndrome or documented liver involvement by lymphoma (see inclusion criterion 7c)
- •h. History of hypersensitivity to study treatments or excipients or to drugs of similar chemical class
- •i. Any other medical condition which makes the patient unsuitable for the study
- •7. Contraception provisions:
- •Females: Due to the teratogenic potential of LEN, FCBP must:
- •All countries except US:
- •a. Not be pregnant (confirmed negative serum pregnancy test) at screening & urine pregnancy test prio
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