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
- 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: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005297-10-ES
- Lead Sponsor
- Cellectar Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
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 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. 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, 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.
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