IOPOFOSINE (131I), 18-(P-IODOPHENYL)OCTADECYL PHOSPHOCHOLINE for Waldenstrom Macroglobulinemia

Inclusion criteria

• {"criterion_text":"- 1. Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval."}
• {"criterion_text":"- 2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2."}
• {"criterion_text":"- 3. Patient is 18 years of age or older."}
• {"criterion_text":"- 4. Life expectancy of at least 6 months."}
• {"criterion_text":"- 5. Received at least two prior lines of therapy for WM."}

Exclusion criteria

• {"criterion_text":"- 1. Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia."}
• {"criterion_text":"- 2. Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy."}
• {"criterion_text":"- 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.)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 5. Anti-cancer therapy within two weeks of initial CLR 131 infusion."}
• {"criterion_text":"- 6. Major surgery within 6 weeks of enrollment."}
• {"criterion_text":"- 7. History of hypersensitivity to thyroid protection medication (e.g., potassium iodide, Lugol’s solution, etc.)"}
• {"criterion_text":"- 8. Known history of human immunodeficiency virus, active or chronic hepatitis C, or hepatitis B infection."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 10. Pregnancy or breast-feeding."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the MRR, which is defined as the proportion of patients following the infusion of CLR 131 with complete response (CR), very good partial response (VGPR), or partial response (PR) determined from criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment up to 12 months post first CLR 131 infusion in WM patients who have received at least two prior lines of therapy.","definition_or_measurement_approach":"Defined in-text: MRR = proportion of patients with CR, VGPR, or PR determined from criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment, measured up to 12 months post first CLR 131 infusion."}

Secondary endpoints

• {"endpoint_text":"- 1. Overall response rate (ORR), defined as the proportion of patients with a MR, PR, VGPR, or CR determined from criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment.","definition_or_measurement_approach":"ORR defined as proportion with MR, PR, VGPR, or CR determined from criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment."}
• {"endpoint_text":"- 2. Treatment free survival (TFS), defined as the time from last CLR 131 dose to time to initiation of subsequent therapy or death.","definition_or_measurement_approach":"TFS measured as time from last CLR 131 dose to initiation of subsequent therapy or death."}
• {"endpoint_text":"- 3. Duration of response (DOR) is defined as the time from the first documentation of response (including CR, VGPR, PR) to PD or death. For DOR, patients who are alive and progression free during this study will have their event time censored on the last disease assessment.","definition_or_measurement_approach":"DOR measured from first documented response (CR/VGPR/PR) to progressive disease (PD) or death; censoring rules specified (censor at last disease assessment if alive and progression-free)."}
• {"endpoint_text":"- 4. Clinical benefit rate (CBR) is defined as the proportion of patients with CR, VGPR, PR, MR, and SD determined from criteria modified from the VIth Waldenstrom’s Macroglobulinemia Criteria for Response Assessment.","definition_or_measurement_approach":"CBR measured as proportion with CR, VGPR, PR, MR, or SD per modified VIth Waldenstrom’s Criteria."}
• {"endpoint_text":"- 5. Safety. Adverse events (AEs), serious AE (SAEs), AEs with Grade ≥ 3, laboratory results, vital signs, electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status (PS).","definition_or_measurement_approach":"Safety assessed by recording AEs, SAEs, Grade ≥3 AEs, lab results, vital signs, ECGs, and ECOG performance status."}

France

Earliest CTIS Part Ii Submission Date

07-12-2023

Latest Decision Or Authorization Date

10-07-2024

Processing Time Days

216

Number Of Sites

2

Number Of Participants

1

Spain

Earliest CTIS Part Ii Submission Date

07-12-2023

Latest Decision Or Authorization Date

10-01-2025

Processing Time Days

400

Number Of Sites

6

Number Of Participants

5

Greece

Earliest CTIS Part Ii Submission Date

07-12-2023

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

798

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Cellectar Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medpace Ellas Monoprosopi I.K.E.

Responsibilities

sponsorDuties codes: 1, 12; contact RS-Advisor-Support@medpace.com

Name

Medpace Finland Oy

Responsibilities

sponsorDuties codes: 1, 2, 4, 6; contact RS-Advisor-Support@medpace.com

Third parties

• {"country":"Greece","full_name":"Medpace Ellas Monoprosopi I.K.E.","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Novasco","duties_or_roles":"sponsorDuties: code 15 (Travel vendor)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Molecular Pathology Laboratory Network Inc.","duties_or_roles":"sponsorDuties: code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Image Analysis Limited","duties_or_roles":"sponsorDuties: code 15 (Imaging analysis and collection)","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: 1, 2, 4, 6","organisation_type":"Pharmaceutical company"}