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
- Waldenstrom MacroglobulinemiaMedDRA version: 25.1Level: LLTClassification code: 10054695Term: Waldenstrom´s macroglobulinemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508671-37-00
- Lead Sponsor
- Cellectar Biosciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 59
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.
1. Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia., 10. Pregnancy or breast-feeding., 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 systemic 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 hepatitis C, or hepatitis B infection., 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.
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