跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/EUCTR2020-005297-10-FR
EUCTR2020-005297-10-FR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)

Cellectar Biosciences, Inc.0 个研究点目标入组 50 人开始时间: 2021年4月15日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
50
研究概览入排标准研究者记录与标识符相似试验

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. 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 first line standard of care.
  • •6. Achieve a sub-optimal response to or failed treatment with a BTK inhibitor.
  • •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 15
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 35

排除标准

  • •1. Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia (subject to the additional laboratory abnormalities listed below). However, stable, tolerable Grade 2 AEs (e.g., neuropathy) and gastrointestinal AEs (e.g., nausea) persistent after adequate management may be allowed after discussion with the Medical Monitor.
  • •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 therapy in the last 2 years or is not in remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy.
  • •5. Anti-cancer therapy within two weeks of initial CLR 131 infusion.
  • •6. Radiation therapy, chemotherapy, immunotherapy within 2 weeks, and investigational therapy within 5 half-lives of eligibility-defining bone marrow biopsy.
  • •7. Major surgery within 6 weeks of enrollment.
  • •8. History of hypersensitivity to thyroid protection medication (e.g., potassium iodide, Lugol’s solution, etc.).
  • •9. Known history of human immunodeficiency virus, hepatitis C, or hepatitis B infection.
  • •10. 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.
  • •11. Pregnancy or breast-feeding.

研究者

相似试验

进行中（未招募）
1 期
Study to evaluate the effects of CLR 131 in patients with B-Cell malignancies (CLOVER-1) and expansion study to evaluate the effects of CLR 131 specifically in patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)Part A: MM (multiple myeloma), CLL/SLL(chronic lymphocytic leukemia/small lymphocytic lymphoma), LPL/WM(lymphoplasmacytic lymphoma/ Waldenstrom's Macroglobulinemia), MZL(marginal zone lymphoma), MCL(mantle cell lymphoma), DLBCL(diffuse large B-cell lymphoma), and CNSL (central nervous system lymphoma).Part B: WM is a B-cell non-Hodgkin lymphoma (NHL), characterized by small B lymphocytes, plasmacytoid lymphocytes, and plasma cells typically involving the bone marrow, lymph nodes, and spleen.MedDRA version: 25.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2020-005297-10-CZCellectar Biosciences, Inc.145
进行中（未招募）
1 期
Study to evaluate the effects of CLR 131 in patients with B-Cell malignancies (CLOVER-1) and expansion study to evaluate the effects of CLR 131 specifically in patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)
CTIS2023-508671-37-00Cellectar Biosciences Inc.59
进行中（未招募）
1 期
Study to evaluate the effects of CLR 131 in patients with B-Cell malignancies (CLOVER-1) and expansion study to evaluate the effects of CLR 131 specifically in patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)The hematologic disease known as Waldenstrom’s Macroglobulinemia (WM). WM is a type of Lymphoplasmacytic lymphoma (LPL), a rare and chronic form of B-cell non-Hodgkin lymphoma (NHL), characterized by small B lymphocytes, plasmacytoid lymphocytes, and plasma cells typically involving the bone marrow, lymph nodes, and spleen.MedDRA version: 21.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 100000004864
EUCTR2020-005297-10-ESCellectar Biosciences, Inc.50
进行中（未招募）
1 期
Study to evaluate the effects of CLR 131 in patients with B-Cell malignancies (CLOVER-1) and expansion study to evaluate the effects of CLR 131 specifically in patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)The hematologic disease known as Waldenstrom’s Macroglobulinemia (WM). WM is a type of Lymphoplasmacytic lymphoma (LPL), a rare and chronic form of B-cell non-Hodgkin lymphoma (NHL), characterized by small B lymphocytes, plasmacytoid lymphocytes, and plasma cells typically involving the bone marrow, lymph nodes, and spleen.MedDRA version: 25.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2020-005297-10-FICellectar Biosciences, Inc.65
进行中（未招募）
1 期
Study to evaluate the effects of CLR 131 in patients with B-Cell malignancies (CLOVER-1) and expansion study to evaluate the effects of CLR 131 specifically in patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)Part A: MM (multiple myeloma), CLL/SLL(chronic lymphocytic leukemia/small lymphocytic lymphoma), LPL/WM(lymphoplasmacytic lymphoma/ Waldenstrom's Macroglobulinemia), MZL(marginal zone lymphoma),MCL(mantle cell lymphoma), DLBCL(diffuse large B-cell lymphoma),and CNSL (central nervous system lymphoma).Part B: WM is a B-cell non-Hodgkin lymphoma (NHL), characterized by small B lymphocytes, plasmacytoid lymphocytes, and plasma cells typically involving the bone marrow, lymph nodes, and spleen.MedDRA version: 25.1Level: LLTClassification code 10054695Term: Waldenstrom's macroglobulinemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2020-005297-10-GRCellectar Biosciences, Inc.170