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Evaluation of Iopofosine I 131 vs. R-CD in WM Patients

NCT07766421 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Waldenstrom Macroglobulinaemia
  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Macroglobulinaemia Refractory
  • Waldenstrom Macroglobulinemia With Nodal Disease
  • Waldenstrom's Macroglobulinemia Recurrent

Interventions

DRUG

Iopofosine I 131

Fractionated dose

DRUG

Rituximab (active comparator)

Rituximab

DRUG

Cyclophosphamate

Cyclophosphamide

DRUG

Dexamethasone

Dexamethasone

Sponsors & Collaborators

  • Cellectar Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2032-01-31
Completion
2035-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766421 on ClinicalTrials.gov