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Targeted radiation shows promise for Hard-to-Treat blood cancers

NCT ID NCT02952508

Disease control Sponsor: Cellectar Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called iopofosine I 131 in people with certain blood cancers (like Waldenstrom macroglobulinemia, multiple myeloma, and lymphomas) that have come back or not responded to standard treatments. The drug delivers radiation directly to cancer cells. The study has two parts: one looks at how many patients benefit across several cancer types, and the other focuses on Waldenstrom macroglobulinemia. About 120 adults aged 18 and older are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\[CLOVER-1\] Inclusion Criteria: All Patients * Histologically or cytologically confirmed MM; Patients with primary or secondary CNSL may be enrolled. * ECOG performance status of 0 to 2 * 18 years of age or older * Life expectancy of at least 6 months * Platelets ≥ 75,000/µL (if full-dose anticoagulation therapy is used, platelets ≥ 100,000/µL are required) * WBC count ≥ 3000/µL * Absolute neutrophil count ≥ 1500/µL * Hemoglobin ≥ 9 g/dL (last transfusion, if any, must be at least 1 week prior to study registration, and no transfusions are allowed between registration and dosing) * Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) * Bilirubin \< 1.5 × ULN * International normalized ratio (INR) \< 2.5 * If patient is on full-dose anticoagulation therapy, the anticoagulation therapy must be reversible and reversal of the anticoagulation therapy must not be life-threatening, as judged by the Investigator * Patients who have undergone stem cell transplant must be at least 100 days from transplant Patients with Multiple Myeloma * At least 5 prior regimens, which must include at least 1 approved proteasome inhibitor (bortezomib, carfilzomib, or ixazomib), at least 1 approved immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide), and at least 1 approved monoclonal antibody (e.g., daratumumab or elotuzumab) with or without maintenance therapy, unless patients are intolerable to such agents or ineligible to receive such agents. * At least triple-class refractory (refractory to a proteasome inhibitor, immunomodulatory agent, and a monoclonal antibody) * Progressive disease defined by any of the following: * 25% increase in serum M-protein from the lowest response value during (or after) last therapy and/or absolute increase in serum M-protein of ≥ 0.5 g/dL * 25% increase in urine M-protein from the lowest response value during (or after) last therapy and/or absolute increase in urine M-protein of ≥ 200 mg/24 h * 25% increase in bone marrow plasma cell percentage from the lowest response value during (or after) last therapy. Absolute bone marrow plasma cell percentage must be ≥ 10% unless prior CR when 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 hypercalcemia \> 11.5 mg/dL * Failure to obtain a partial response or better to current treatment, or cannot further improve their response to current treatment * Appearance of new extramedullary disease * Measurable disease defined by any of the following: * Serum M-protein \> 0.5 g/dL * Urine M-protein \> 200 mg/24 h * Serum FLC assay: Involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal. \[CLOSED\] Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma/Waldenstom Macroglobulinemia, or Marginal Zone Lymphoma * Prior treatment with at least 2 prior regimens, which may include chemotherapy, an approved anti-CD20 antibody with or without maintenance therapy, and an approved targeted agent, unless patients are ineligible to receive such agents * Patients with Helicobacter pylori+ mucosa-associated lymphoid tissue lymphoma must have received 1 prior antibiotic regimen for H pylori * At least 1 measurable nodal lesion with longest diameter \> 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter \> 10 mm. Additional parameters (e.g., measurable IgM for patients with Lymphoplasmacytic Lymphoma) may be allowed if they meet current NCCN guidelines for symptomatic disease. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. \[CLOSED\] Patients with Mantle Cell Lymphoma * Prior treatment with at least 1 prior regimen * At least 1 measurable nodal lesion with longest diameter \> 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter \> 10 mm. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. \[CLOSED\] Patients with Diffuse Large B-Cell Lymphoma * Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline; or is intolerable to such agents. Relapsed disease is defined as either recurrence of disease after a CR or PD after achieving a partial response (PR) or SD. Refractory disease is defined as failure to achieve at least SD with any 1 line of therapy or with PD ≤ 3 months of the most recent chemotherapy regimen. * At least 1 measurable nodal lesion with longest diameter \> 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter \> 10 mm. Patients with uptake by FDG-PET scan may be allowed with prior approval of Sponsor. Patients with CNS Lymphoma * Must have biopsy-proven disease and must have received at least one prior intervention for their disease. * Must be at least two weeks from CNS biopsy before administration of iopofosine I 131. * Must have at least one lesion with enhancement on brain imaging. * Stable (or decreasing) dose of corticosteroids or anti-convulsant medication for at least 7 days prior to dosing \[CLOVER-1\] Exclusion Criteria: * Ongoing Grade 2 or greater toxicities due to previous therapies. Stable, tolerable Grade 2 AEs (eg, neuropathy) may be allowed. * Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. * Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.) * Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord * For patients with CLL/SLL, LPL, or MZL, transformation to a more aggressive form of NHL * Ongoing chronic immunosuppressive therapy * Clinically significant bleeding event within prior 6 months * Ongoing anti-platelet therapy (except low-dose aspirin \[eg, 81 mg daily\] for cardioprotection) * Anti-cancer therapy within two weeks of initial iopofosine I 131 infusion. Low dose dexamethasone for symptom management is allowed * Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2 weeks of eligibility-defining bone marrow biopsy. * For patients with primary or secondary CNSL, active bleeding in the tumor bed and/or uncontrolled seizure activity \[CLOVER-WaM\] Inclusion Criteria * 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 \[CLOVER-WaM\] Exclusion Criteria * Ongoing Grade 2 or greater toxicities due to previous therapies, excluding alopecia. * Prior external-beam RT resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. * Prior total body or hemi-body irradiation. Patients who have received prior low-dose total body or hemi-body irradiation may be allowed on a case-by-case basis after discussion with Sponsor (considerations may include factors such as time since irradiation, total lifetime accumulated dose, etc.) * Patients with second malignancies in addition to WM, if the second malignancy has required therapy in the last 2 years or is not in remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy * Anti-cancer therapy within two weeks of initial iopofosine I 131 infusion. * Need for acute treatment of WM (e.g., those with hyperviscosity)

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Blood Protein Disorders diffuse large B-cell lymphoma hematologic disorder immunoproliferative disorder lymphoma Lymphoma, B-Cell, Marginal Zone lymphoplasmacytic lymphoma lymphoproliferative syndrome mantle cell lymphoma marginal zone lymphoma monoclonal gammopathy neoplasm non-Hodgkin lymphoma plasma cell myeloma plasma cell neoplasm primary central nervous system lymphoma Recurrence Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central nervous system lymphoma Chronic lymphocytic leukemia Diffuse large B cell lymphoma Lymphoplasmacytic lymphoma Mantle cell lymphoma Marginal zone lymphoma Multiple myeloma Small lymphocytic lymphoma Waldenstrom macroglobulinemia

Contacts and locations

Locations

  • Cellectar Biosciences

    Atlanta, Georgia, 30332, United States

  • Cellectar Biosciences

    Bethesda, Maryland, 20817, United States

  • Cellectar Biosciences

    North Bergen, New Jersey, 07047, United States

  • Cellectar Biosciences

    Canton, Ohio, 44718, United States

  • Cellectar Biosciences

    Greenville, South Carolina, 29605, United States

  • Cellectar Biosciences

    Adelaide, South Australia, 5000, Australia

  • Cellectar Biosciences

    Salvador, Estado de Bahia, 40050-410, Brazil

  • Cellectar Biosciences

    Curitiba, Paraná, 80810-050, Brazil

  • Cellectar Biosciences

    Porto Alegre, RioGrande Do Sul, 90035-903, Brazil

  • Cellectar Biosciences

    Blumenau, Santa Catarina, 89010-340, Brazil

  • Cellectar Biosciences

    Helsinki, 00029, Finland

  • Cellectar Biosciences

    Pessac, 33600, France

  • Cellectar Biosciences

    Poitiers, 86021, France

  • Cellectar Biosciences

    Barcelona, 08036, Spain

  • Cellectar Biosciences

    Madrid, 28027, Spain

  • Cellectar Biosciences

    Madrid, 28040, Spain

  • Cellectar Biosciences

    Salamanca, 37007, Spain

  • Cellectar Biosciences

    Ankara, 06620, Turkey (Türkiye)

  • Cellectar Biosciences

    Bornova, 35100, Turkey (Türkiye)

  • Cellectar Biosciences

    Istanbul, 34093, Turkey (Türkiye)

  • Cellectar Biosciences Site

    Charleston, South Carolina, 29425, United States

  • Cellectar Biosciences Site

    Hradec Králové, 500 05, Czechia

  • Cellectar Biosciences Site

    Rio, Greece

  • Cellectar Biosciences Site

    Jerusalem, Israel

  • Cellectar Biosciences site

    Los Angeles, California, 90095, United States

  • Cellectar Biosciences site

    Redlands, California, 92373, United States

  • Cellectar Biosciences site

    Washington D.C., District of Columbia, 20007, United States

  • Cellectar Biosciences site

    Jacksonville, Florida, 32224, United States

  • Cellectar Biosciences site

    Miami, Florida, 33165, United States

  • Cellectar Biosciences site

    Tampa, Florida, 33612, United States

  • Cellectar Biosciences site

    Maywood, Illinois, 60153, United States

  • Cellectar Biosciences site

    Warrenville, Illinois, 60555, United States

  • Cellectar Biosciences site

    Westwood, Kansas, 66205, United States

  • Cellectar Biosciences site

    New Orleans, Louisiana, 70121, United States

  • Cellectar Biosciences site

    Baltimore, Maryland, 21287, United States

  • Cellectar Biosciences site

    Boston, Massachusetts, 02215, United States

  • Cellectar Biosciences site

    Buffalo, New York, 14263, United States

  • Cellectar Biosciences site

    New York, New York, 10065, United States

  • Cellectar Biosciences site

    Rochester, New York, 14642, United States

  • Cellectar Biosciences site

    Durham, North Carolina, 27705, United States

  • Cellectar Biosciences site

    Cincinnati, Ohio, 45219, United States

  • Cellectar Biosciences site

    Knoxville, Tennessee, 37920, United States

  • Cellectar Biosciences site

    Dallas, Texas, 75246, United States

  • Cellectar Biosciences site

    Dallas, Texas, 75390, United States

  • Cellectar Biosciences site

    Houston, Texas, 77030, United States

  • Cellectar Biosciences site

    Seattle, Washington, 98109, United States

  • Cellectar Biosciences site

    Madison, Wisconsin, 53792, United States

  • Cellectar Biosciences site

    Concord, New South Wales, 2139, Australia

  • Cellectar Biosciences site

    Athens, 115 28, Greece

  • Cellectar Biosciences site

    Barcelona, 08908, Spain

  • Cellectar Biosciences site

    Zaragoza, 50009, Spain

  • Cellectar Biosciences site

    London, NW1 2PG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.