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)
- Conditions
- 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005297-10-CZ
- Lead Sponsor
- Cellectar Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 145
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
Part B:
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
Part A:
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
Part B:
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method