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)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 65

Inclusion Criteria

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 49

Exclusion Criteria

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 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 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

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