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.
Histologically and serologically confirmed diagnosis of WM.
Received at least one prior therapy for WM.
Received treatment with a BTKi (including covalent BTKi or non-covalent BTKi).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
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.
Parallel
Iopofosine I 131
DrugFractionated dose
Rituximab (active comparator)
DrugRituximab
Cyclophosphamate
DrugCyclophosphamide
Dexamethasone
DrugDexamethasone
Superiority of progression free survival (PFS)
A survival analysis will be performed comparing treatment arms using the Cox Proportional Hazard model to determine the hazard ratio, corresponding 95% CI, and p-value to determine superiority between iopofosine I 131 and R-CD.
Major response rate (MRR)
Proportion of participants with CR, VGPR, or PR determined from the modified IWWM-11 response criteria. Corresponding 95% CO using the Clopper-Pearson method will be reported.
Overall response rate (ORR)
Proportion of participants with CR, VGPR, PR, or MR determined from the modified IWWM-11 response criteria. Corresponding 95% CO using the Clopper-Pearson method will be reported.
VGPR/CR rates
Proportion of participants with VGPR or CR determined from the modified IWWM-11 response criteria. The corresponding 95% CI using the Clopper-Pearson method will be reported for each treatment group
Number of adverse events related to trial medications (iopofosine I 131 or R-CD)
Adverse events are graded per NCI CTCAE v5.0
Overall survival (OS)
The Kaplan-Meier method, including descriptive statistics, median OS, and corresponding median OS 95% CI, will be used to characterize OS rates for both treatment groups
Duration of response (DOR)
The KM method, including descriptive statistics, median DOR, and corresponding median DOR 95% CI, will be used for analysis of DOR for both treatment groups.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
