Evaluation of Iopofosine I 131 vs. R-CD in WM Patients (NCT07766421) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Evaluation of Iopofosine I 131 vs. R-CD in WM Patients
219 participantsStarted 2026-12
Plain-language summary
The goal of this clinical trial is to evaluate whether iopofosine I 131 is more effective than the combination Rituximab-Cyclophosphamide-Dexamethasone (R-CD). The main question the study aims to answer is:
• Does iopofosine I 131 work better than R-CD when looking at the length of time during and after the treatment that a patient lives with WM but it does not get worse.
Participants will:
* Be randomly assigned to received either iopofosine I 131 or R-CD.
* If assigned to iopofosine I 131, have it administered via infusion 2 times each cycle for a total of 2 cycles (each cycle is about 3 months long).
* If assigned to R-CD, it will be administered for up to six cycles, and each cycle is 3-weeks long
* Visit the clinic once every 3 weeks for checkups and testing.
* Report any side effects or new medications.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Platelets ≥ 75,000/uL.
. Absolute neutrophil count (ANC) ≥ 1000/uL
. Hemoglobin ≥ 8 g/dL, that can be maintained by packed red blood cell (PRBC) transfusions
. Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 (as calculated using the CKD-EPI 2021 formula) OR serum creatinine ≤ 1.5 x ULN
. Bilirubin \< 1.5 × ULN, except for patients with Gilbert's syndrome, who may be enrolled if bilirubin is \< 3 x ULN or direct bilirubin is \< 1.5 x ULN.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Superiority of progression free survival (PFS)
Timeframe: From baseline randomization through study completion of progressive disease, or death due to any reason (whichever status is recorded first).
. Anti CD-20 MoAb \< 6 months prior to study drug administration.
. Any conventional cytotoxic chemotherapy ≤ four weeks prior to study drug administration.
. Non-anti CD20 MoAb therapy for the treatment of WM ≤ three months prior to study drug administration. i. The only exception to this is for those patients who have documented evidence of progression while receiving non-anti CD20 MoAb therapy.
. BTKi therapy ≤ 48 hours prior to study drug administration.
. Any investigational agents ≤ two weeks or five half-lives, whichever is shorter, prior to study drug administration.
. Vertebral bodies: Cervical 0.5%, thoracic 1%, lumbar 2% per vertebral body
. Hemipelvis (ilium, acetabulum, ischium): 13% per side