EUCTR2020-005297-10-CZ进行中（未招募）1 期
An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM) - Phase 2 Study of CLR 131 with B-Cell Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
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
- 性别
- All
入选标准
- •Part A (All patients):
- •Histologically or cytologically confirmed MM; CLL/SLL, LPL/WM, MZL; or MCL OR histologically proven, DLBCL. Patients with primary or secondary CNSL may be enrolled.
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- •Patient is 18 years of age or older.
- •Life expectancy of at least 6 months.
- •Part A (Multiple myeloma patients)
- •At least quadruple-class refractory disease
- •1. Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval.
- •2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- •3. Patient is 18 years of age or older.
- •4. Life expectancy of at least 6 months.
- •5. Received at least two prior lines of therapy for WM.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1. Ongoing Grade 2 or greater toxicities due to previous therapies
- •2. Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy.
- •3. Prior total body or hemi-body irradiation.
- •4. Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord
- •5. Ongoing chronic immunosuppressive therapy
- •6. Clinically significant bleeding event, as judged by Investigator, within prior 6 months
- •7. Ongoing anti-platelet therapy
- •8. Anti-cancer therapy within two weeks of initial CLR 131 infusion
- •9. Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2 weeks of eligibility-defining bone marrow biopsy
- •10. Any other concomitant serious illness or organ system dysfunction that in the opinion of the Investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- •11. Active COVID-19 infection with positive test, including patients who are asymptomatic. Patients with prior exposure or infection who are antibody positive, but with no evidence of active COVID-19 disease would be eligible.
- •12. For patients with primary or secondary CNSL, active bleeding in the tumor bed and/or uncontrolled seizure activity
- •13. Major surgery within 6 weeks of enrollment
- •14. History of hypersensitivity to thyroid protection medication
- •15. Known history of human immunodeficiency virus, hepatitis C, or hepatitis B infection
- •16. Presence of active infection within 72 hours prior to dosing;
- •17. Pregnancy or breast-feeding
- •1. Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia.
- •2. Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy.
- •3. Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.).
- •4. Patients with second malignancies in addition to WM, if the second malignancy has required systematic therapy in the last 2 years. Exceptions
- •to this criterion include secondary malignancies in remission, successfully treated skin malignancies, skin malignancies only requiring topic treatment or surgical excision, or other cancer that do not require therapy.
- •5. Anti-cancer therapy within two weeks of initial CLR 131 infusion.
- •6. Major surgery within 6 weeks of enrollment.
- •7. History of hypersensitivity to thyroid protection medication (e.g., potassium iodide, Lugol’s solution, etc.).
- •8. Known history of human immunodeficiency virus. Active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) defined by positive polymerase chain reaction (PCR). Testing is only required with known or suspected prior history. Hepatitis patients receiving antiviral therapy (e.g., entecavir) who do not have a positive PCR are eligible.
- •9. Presence of active infection within 72 hours prior to dosing; patients with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible as long as there is no evidence of active infection and the antibiotics, antifungals, or antivirals are not included on the list of prohibited medications.
- •10. Pregnancy or breast-feeding.
研究者
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