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Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom

Study acronym: CLOVER-WaM
StatusActive, Not Recruiting
PhasePhase 2
Started2017-07-26
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2026 (before its estimated June 22, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-16
Study Identification, Study Status v29
Primary completion date2025-12-22→2026-06-22
Completion date2026-12-22→2027-12-22
Study title-25 characters
Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and PivotalWith Expansion in Waldenstrom Macroglobulinemia
2025-03-25
Study Status v28
Primary completion date2024-12-22→2025-12-22
2024-09-10
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v27
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-11-30→2024-12-22
Completion date2025-06-30→2026-12-22
Study sitesdetails revised at 52 of 52 sites
2024-06-04
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v26
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 52 of 52 sites
2024-06-03
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 52 of 52 sites
Show 24 earlier versions
2024-01-19
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v24
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 52 of 52 sites
2024-01-12
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v23
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 52 of 52 sites
2024-01-05
Study Status v22
Re-verified, no change to tracked fields
2023-08-18
Study Status, Contacts/Locations v21
Primary completion date2023-06-30→2024-11-30
Completion date2025-06→2025-06-30
Study sites43→52
2022-12-30
Study Status, Contacts/Locations v20
Study sites24→43
2022-08-11
Study Status v19
Primary completion date2022-09→2023-06-30
2022-08-03
Study Status, Contacts/Locations v18
Study sites23→24
2022-05-05
Study Status, Contacts/Locations v17
Study sites21→23
2022-01-21
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v16
Study sites15→21
InterventionsCLR 131 fractionated dose (Drug), CLR 131 multiple dose (Drug), CLR 131 single dose (Drug)→Iopofosine I 131 fractionated dose (Drug), Iopofosine I 131 multiple dose (Drug), Iopofosine I 131 single dose (Drug)
Eligibility criteria+27 characters
[...] at least two weeks from CNS biopsy before administration of CLRiopofosine I 131. Must have at least one lesion with enhancement on brai [...] protection) Anti-cancer therapy within two weeks of initial CLRiopofosine I 131 infusion. Low dose dexamethasone for symptom management [...] ire therapy Anti-cancer therapy within two weeks of initial CLRiopofosine I 131 infusion. Need for acute treatment of WM (e.g., those with hyperviscosity)
Study description+27 characters
[...] ient population with significantly reduced life-expectancy. CLRIopofosine I 131 is a targeted radiotherapeutic that exploits the select [...] has previously been used approved for use in select tumors. CLRIopofosine I 131 has been evaluated in over 80 xenograft and spontaneous [...] osciences has chosen to expand this ongoing study to assess CLRiopofosine I 131 in a pivotal expansion cohort in Waldenstrom's Macroglo [...]
Study title+19 characters
Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia
2021-11-30
Study Status, Contacts/Locations v15
Study sites14→15
2021-09-30
Study Status, Contacts/Locations v14
Study sites12→14
2021-09-24
Study Status, Study Design, Contacts/Locations v13
Study sites11→12
2021-08-04
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Study sites10→11
Study arms3→4
Eligibility criteria+145 characters
[CLOVER-1] Inclusion Criteria: All Patients Histologically or cytologically confirmed MM; CLL/SLL, LPL/WM, MZL; or MCL OR histologically proven, DLBCL. Patients with transformedprimary DLBCLor aresecondary allowedCNSL may be enrolled. ECOG performance status of 0 to 2 18 years of age or older [...] g) Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 Aspartate aminotransferase (AST) and Alanine aminotransferase <(ALT) 3≤ 2.5 × upper limit of normal (ULN) Bilirubin < 1.5 × ULN Interna [...] ays from transplant Patients with Multiple Myeloma At least 25 prior regimens, which must include at least 1 app [...] [...]
Secondary endpoints7 to 9 entries
Part A [CLOVER-1] PreliminaryOverall efficacyResponse - overall response rateRate Part A [CLOVER-1] timeProgression toFree progressionSurvival Part A [CLOVER-1] overallTime survivalto Next Treatment Part A [CLOVER-1] Overall Survival Part A [CLOVER-1] Duration of Response Part B [CLOVER-WaM] Overall responseResponse rateRate Part B [CLOVER-WaM] treatmentTreatment freeFree survivalSurvival Part B [CLOVER-WaM] durationDuration of responseResponse Part B [CLOVER-WaM] clinicalClinical benefitBenefit rateRate
Study description-133 characters
[...] ctory B-cell lymphomas have proven very difficult to treat. Success rate, defined as complete or partial response, is as low as 2% to 4% in many of these diseases, and they remain an area of a significant unmet medical need. Patients that have failed BTKiprior therapy, including WM patients, represent a very challenging patien [...] ohort in Waldenstrom's Macroglobulinemia patients that have failedreceived BTKiat treatmentleast two prior lines of therapy.
2021-01-27
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
Primary completion date2020-07→2022-09
Completion date2020-10→2025-06
Enrollment target80→120
Study arms1→3
Eligibility criteria+40 characters
[CLOVER-1] Inclusion Criteria: All Patients Histologically or cytologically confirmed MM; CLL/SLL, LPL/WM, MZL; or MCL OR histologically proven, DLBCL. Patients with [...] (if full-dose anticoagulation therapy is used, platelets ≥ 150100,000/µL are required) WBC count ≥ 3000/µL Absolute neutrophi [...] m cell transplant must be at least 100 days from transplant Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits Patient or his or her legal representative has the ability to read, under [...] [...]
Secondary endpoints1 to 7 entries
Part A [CLOVER-1] Preliminary efficacy - overall response rate, Part A [CLOVER-1] time to progression, Part A [CLOVER-1] overall survival Part B [CLOVER-WaM] Overall response rate Part B [CLOVER-WaM] treatment free survival Part B [CLOVER-WaM] duration of response Part B [CLOVER-WaM] clinical benefit rate
Primary endpoints1 to 2 entries
Part A [CLOVER-1] Clinical benefit rate Part B [CLOVER-WaM] Major Response Rate
Study description+53 characters
[...] nd they remain an area of a significant unmet medical need. Patients that have failed BTKi, including WM patients, represent a very challenging patient population with significantly reduced life-expectancy. CLR 131 is a radioiodinatedtargeted therapeuticradiotherapeutic 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 (CLR1404) is radiolabeled with the isotoperadioisotope iodine-131 (I-131) which has previously been used approved for use in select tumor [...] [...]
Study sitesdetails revised at 2 of 10 sites
Study title+32 characters
Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia
2020-06-17
2 amendments v9-v10
2 re-verifications since 2020-04-07, no change to tracked fields
2020-01-17
Study Status, Arms and Interventions, Eligibility v8
Primary completion date2019-12→2020-07
Completion date2020-03→2020-10
InterventionsCLR 131 multiple dose (Drug), CLR 131 single dose (Drug)→CLR 131 fractionated dose (Drug), CLR 131 multiple dose (Drug), CLR 131 single dose (Drug)
Eligibility criteria-39 characters
[...] e or older Life expectancy of at least 6 months Platelets ≥ 10075,000/µL (if full-dose anticoagulation therapy is used, plate [...] within 2 weeks of eligibility-defining bone marrow biopsy. History of hypersensitivity to iodine Any other concomitant serious illness or organ system dysfun [...]
2019-07-22
Study Status v7
Re-verified, no change to tracked fields
2019-01-07
Study Identification, Study Status, Arms and Interventions, Eligibility v6
Primary completion date2018-12→2019-12
Completion date2019-03→2020-03
InterventionsCLR 131 (Drug)→CLR 131 multiple dose (Drug), CLR 131 single dose (Drug)
Eligibility criteria+969 characters
[...] med MM; CLL/SLL, LPL, MZL; or MCL OR histologically proven, deDLBCL. Patients novo,with transformed DLBCL are allowed. ECOG performance status of 0 to 2 18 years of age or older [...] ), with or without maintenance therapy, unless patients are intolerable to such agents or ineligible to receive such agents. Bone marrow biopsy within 28 days of CLR 131 infusion demonstrating at least 5% plasma cell involvement Progressive disease defined by any of the following: 25% inc [...] ase must be > 10 mg/dL New onset hypercalcemia > 11.5 mg/dL Failure to obtain a partial response or better to current treatment, or c [...] [...]
Study title+11 characters
Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies (CLOVER-1)
2018-03-15
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v5
Eligibility criteria+16 characters
[...] tial must have a negative pregnancy test within 24 hours of enrollmentdosing Women of childbearing potential and men who are able to fat [...] rug Patients with Multiple Myeloma At least 2 prior regimens and no more than 5, which must include at least 1 approved proteasome inhibitor (bortezomib, carfilzomib, or carfilzomibixazomib) and at least 1 approved immunomodulatory agent (thalidomid [...] n absolute bone marrow plasma cell percentage must be ≥ 5%. 25% increase in serum FLC level from the lowest response value during (or after) last therapy; the absolute increase must be > 10 mg/dL New onset hypercalc [...] [...]
Secondary endpoints1 entry, revised
Preliminary efficacy - overall response rate, time to progression, overall survival
Primary endpoints1 entry, revised
PreliminaryClinical efficacy - objective responsebenefit rate
Study description+1,365 characters
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. Success [...]
2018-01-16
Study Status, Contacts/Locations v4
Study sites7→10
2017-10-27
Study Status, Contacts/Locations v3
Study sites6→7
2017-08-29
Study Status, Contacts/Locations v2
Start dateestimated 2017-07→confirmed 2017-07-26
Study sites3→6
2017-07-17
Not Yet Recruiting→Recruiting Study Status, Oversight, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2017-12→2018-12
Completion date2018-03→2019-03
Start date2016-12→2017-07
2016-11-01
Original filing
Cellectar Biosciences, Inc.
5 trials monitored
See 2 trials at risk
Leukemia
2,553 trials monitored
See 134 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
and 3 more diseases
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.
Trial Details
NCT Number NCT02952508
Lead Sponsor Cellectar Biosciences, Inc.
Conditions Waldenstrom Macroglobulinemia, Multiple Myeloma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma +1 more
Enrollment 120 participants
Start Date 2017-07-26
Primary Completion 2026-06-22 (estimated)
Study Completion 2027-12-22 (estimated)
Updated on ClinicalTrials.gov 2026-03-18