EUCTR2021-003397-32-PL进行中（未招募）1 期
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma - A Single-Cohort Study of MK-2140 in rrDLBC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Has relapsed or refractory DLBCL, has progressed after at least 2 lines
- •of prior therapy, and has progressed after auto-SCT or is auto-SCT
- •ineligible. Must have received prior multiagent regimen that includes an
- •alkylating agent, anthracycline, and anti-CD20 monoclonal antibody
- •a Relapsed disease: progression (Lugano Response Criteria) =6 months
- •from completion of the most recent therapy after achieving an overall
- •response of PR or CR
- •b Refractory disease: failure to achieve CR or PR to the most recent
- •therapy OR disease progression (Lugano Response Criteria) <6 months
- •from completion of the most recent therapy after achieving an overall
- •response of PR or CR
- •c Ineligibility for auto-SCT:
- •Is >65 years old
- •Has organ dysfunction or comorbidities precluding the use of HDT or auto-SCT
- •Has not responded to salvage therapy
- •Has refused auto-SCT
- •Has an inability to successfully collect peripheral blood stem cells
- •2. Histologically confirmed diagnosis of DLBCL, according to the WHO
- •classification of neoplasms of the hematopoietic and lymphoid tissues,
- •including: DLBCL, NOS, germinal center B-cell type, or activated B-cell
- •type; DLBCL leg-type; EBV+ DLBCL, NOS; and T cell histiocytic-rich
- •DLBCL DLBCL with overexpression of MYC, BCL2, and/or BCL6 proteins
- •without rearrangement are also classified as DLBCL. DLBCL (HGBL) with
- •MYC, BCL2, and/or BCL6 rearrangement will also be included
- •3. a. Has radiographically measurable DLBCL per the Lugano Response
- •Criteria, with at least 1 nodal lesion (nonirradiated) that is >1.5 cm in
- •the long axis, regardless of length of the short axis, AND/OR extranodal
- •lesion of =1.0 cm in the long and short axis and
- •b. Has PET positive disease verified by BICR at Screening defined as 4-5
- •on a 5-point scale
- •4. Has progressed after CAR-T therapy or is ineligible for CAR-T cell
- •5. Life expectancy of at least 3 months, in the opinion of the investigator
- •6. Is male or female, from 18 years of age inclusive, at the time of
- •providing the informed consent
- •7. Male participants are eligible to participate if they agree to the
- •following during the intervention period and for at least the time needed
- •to eliminate each study intervention after the last dose of study
- •intervention. The length of time required to continue contraception for
- •each study intervention is:
- •Zilovertamab vedotin: 110 days
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and
- •usual lifestyle and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic
- •Contraceptive use by men should be consistent with local regulations
- •8. A female participant is eligible to participate if not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and:
- 另有 10 项未显示
排除标准
- •Has received a diagnosis of PMBCL.
- •2. Has undergone solid organ transplant at any time.
- •3. Has clinically significant (ie, active) cardiovascular disease: cerebral
- •vascular accident/stroke (<6 months prior to enrollment), myocardial
- •infarction (<6 months prior to enrollment), unstable angina, congestive
- •heart failure (New York Heart Association Classification Class = II),
- •serious cardiac arrhythmia requiring medication, arterial
- •thromboembolism, cerebrovascular thromboembolism (<6 months prior
- •to enrollment), uncontrolled Grade =3 hypertension (diastolic blood
- •pressure =100 mm Hg or systolic blood pressure =160 mm Hg) despite
- •antihypertensive therapy; or significant conduction system ECG
- •abnormalities, including second-degree AV block type II, third-degree
- •AV block, or Grade =2 bradycardia, or serious cardiac arrhythmia
- •requiring medication.
- •4. Known history of liver cirrhosis.
- •5. Has pericardial effusion or clinically significant pleural effusion.
- •6. Has baseline peripheral neuropathy> Grade 1.
- •7. Has a history of a second malignancy, unless potentially curative
- •treatment has been completed with no evidence of malignancy for 2
- •8. Has a demyelinating form of Charcot-Marie-Tooth disease.
- •9. Transformed DLBCL from indolent lymphoma.
- •10. In participants with prior allo-SCT, acute GVHD or ongoing evidence
- •of chronic GVHD manifesting as Grade =2 serum bilirubin, Grade =3 skin
- •involvement, or Grade =3 diarrhea or requiring systemic
- •immunosuppression for treatment/prophylaxis for their GVHD.
- •11. Has received prior therapy with a ROR1-directed therapy.
- •12. Has contraindication to any of the study intervention components.
- •13. Has received prior systemic anticancer therapy, including
- •investigational agents within 4 weeks prior to the first dose of study
- •intervention.
- •14. Has received prior radiotherapy within 28 days of start of study
- •intervention. Participants must have recovered from all radiation-related
- •toxicities.
- •15. Has ongoing corticosteroid therapy (exceeding 30 mg daily of
- •prednisone equivalent). Prednisone equivalent dosing must have been
- •stable for at least 4 weeks prior to C1D1.
- •16. Has received a live or live-attenuated vaccine within 30 days before
- •the first dose of study intervention. Administration of killed vaccines are
- •17. Has received a strong inhibitor or inducer of CYP3A4 (including
- •itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days
- •prior to C1D1 or expected requirement for chronic use of a strong
- •CYP3A4 inhibitor or inducer during the study intervention period and for
- •30 days after the last dose of study intervention.
- •18. Is currently participating in or has participated in a study of an
- •investigational agent or has used an investigational device within 4
- •weeks before the first dose of study intervention.
- •19. Has known active CNS lymphoma involvement or active CNS
- •involvement by lymphoma. Participants with prior CNS involvement are
- •eligible if their CNS disease is in radiographic, cytological (for
- •cerebrospinal fluid disease), and clinical remission.
- 另有 8 项未显示
研究者
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