EUCTR2021-003397-32-NO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) =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) <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 orauto-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 over-expression 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 (non-irradiated) 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 post-CAR-T cell therapy failure or is ineligible for CAR-T cell therapy
- •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 signing 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 she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and:
- •- Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows:
- •? Zilovertamab Vedotin 50 days
- •The investigator should evaluate the potential for contraceptive method fai
排除标准
- •1. 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 years.
- •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 allowed.
- •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 Cycle 1 of study therapy
- •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.
- •20. Has an active infection requiring systemic therapy.
- •21. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority.
- •22. Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- •23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's partici
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