Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia
18 Years and older, Male and Female
Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell
malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia
(WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma
(DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with
standard therapy for their underlying malignancy. Part B (CLOVER-WaM) is a pivotal efficacy
study evaluating IV administration of iopofosine I 131 in patients with WM that have received
at least two prior lines of therapy.
B-cell malignancies represent a diverse collection of diseases and, taken together, make up
the majority of hematologic malignancies. B-cell lymphomas represent the largest percentage
of these neoplasms, and the relapsed and/or refractory B-cell lymphomas have proven very
difficult to treat. Patients that have failed prior therapy, including WM patients, represent
a very challenging patient population with significantly reduced life-expectancy.
Iopofosine I 131 is a targeted radiotherapeutic that exploits the selective uptake and
retention of Cellectar's proprietary phospholipid ethers (PLEs) by malignant cells. Cellectar
Biosciences' novel cancer-targeted small-molecule compound is radiolabeled with the
radioisotope iodine-131 (I-131) which has previously been used approved for use in select
tumors. Iopofosine I 131 has been evaluated in over 80 xenograft and spontaneous (transgenic)
tumor models where it was demonstrated to be effective in eliminating tumors.
Based on the critical unmet medical need for effective agents with novel mechanisms of action
in B-cell malignancies, Cellectar Biosciences has chosen to expand this ongoing study to
assess iopofosine I 131 in a pivotal expansion cohort in Waldenstrom's Macroglobulinemia
patients that have received at least two prior lines of therapy.
- Histologically or cytologically confirmed WM. Patients with a diagnosis of LPL may be enrolled with prior Sponsor approval.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (Appendix C)
- Patient is 18 years of age or older
- Life expectancy of at least 6 months
- Received at least two prior lines of therapy for WM
- Measurable IgM (above upper limit of normal) OR at least one measurable nodal lesion with longest diameter > 15 mm or one measurable extranodal lesion (e.g., hepatic nodule) with longest diameter > 10 mm [CLOVER-WaM]
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