Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia (CLOVER-WaM)

January 19, 2024 updated by: Cellectar Biosciences, Inc.

An Open-Label, Multicenter, Phase 2 Study of Iopofosine I 131 (CLR 131) in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients With Waldenstrom Macroglobulinemia (CLOVER-WaM)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Cellectar Biosciences site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40050-410
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
    • Parana
      • Curitiba, Parana, Brazil, 80810-050
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
    • RioGrande Do Sul
      • Porto Alegre, RioGrande Do Sul, Brazil, 90035-903
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Recruiting
        • Cellectar Biosciences
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Cellectar Biosciences site
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • Cellectar Biosciences
  • France
      • Pessac, France, 33600
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Poitiers, France, 86021
        • Recruiting
        • Cellectar Biosciences
  • Greece
      • Athens, Greece, 115 28
        • Recruiting
        • Cellectar Biosciences site
      • Rio, Greece
        • Recruiting
        • Cellectar Biosciences site
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Cellectar Biosciences site
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Barcelona, Spain, 08908
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
      • Madrid, Spain, 28027
        • Recruiting
        • Cellectar Biosciences
      • Madrid, Spain, 28040
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Salamanca, Spain, 37007
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Zaragoza, Spain, 50009
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
  • Turkey
      • Ankara, Turkey, 06620
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Bornova, Turkey, 35100
        • Recruiting
        • Cellectar Biosciences
        • Contact:
          • Cellectar Biosciences
      • Istanbul, Turkey, 34093
        • Recruiting
        • Cellectar Biosciences
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
      • Redlands, California, United States, 92373
        • Recruiting
        • Cellectar Biosciences site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Cellectar Biosciences site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Cellectar Biosciences site
      • Miami, Florida, United States, 33165
        • Recruiting
        • Cellectar Biosciences site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Recruiting
        • Cellectar Biosciences
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Active, not recruiting
        • Cellectar Biosciences site
      • Warrenville, Illinois, United States, 60555
        • Active, not recruiting
        • Cellectar Biosciences site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Active, not recruiting
        • Cellectar Biosciences site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Active, not recruiting
        • Cellectar Biosciences site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Cellectar Biosciences site
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Cellectar Biosciences
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
    • New Jersey
      • North Bergen, New Jersey, United States, 07047
        • Recruiting
        • Cellectar Biosciences
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Cellectar Biosciences site
      • New York, New York, United States, 10065
        • Recruiting
        • Cellectar Biosciences site
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • Cellectar Biosciences site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Cellectar Biosciences
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Cellectar Biosciences site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Cellectar Biosciences site
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Cellectar Biosciences
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • Cellectar Biosciences site
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Cellectar Biosciences site
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Cellectar Biosciences site
        • Contact:
          • Cellectar B site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Cellectar Biosciences site
    • Washington
      • Seattle, Washington, United States, 98109
        • Active, not recruiting
        • Cellectar Biosciences site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Cellectar Biosciences site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

[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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iopofosine I 131, intravenous administration WM
Iopofosine I 131 in Waldenstroms Macroglobulinemia
Drug: Iopofosine I 131 single dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 multiple dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 fractionated dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Experimental: Iopofosine I 131, intravenous administration MM
Iopofosine I 131 in Multiple Myeloma
Drug: Iopofosine I 131 single dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 multiple dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 fractionated dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Experimental: Iopofosine I 131, intravenous administration CNS Lymphoma
Iopofosine I 131 in Central Nervous System Lymphoma
Drug: Iopofosine I 131 fractionated dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Experimental: Iopofosine I 131 intravenous administration NHL [CLOSED]
Iopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma
Drug: Iopofosine I 131 single dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 multiple dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131
Drug: Iopofosine I 131 fractionated dose
Radiopharmaceutical
Other Names:
  • I-131-CLR1404
  • CLR 131

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A [CLOVER-1] Clinical benefit rate
Time Frame: 84 days
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
84 days
Part B [CLOVER-WaM] Major Response Rate
Time Frame: 12 months
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A [CLOVER-1] Overall Response Rate
Time Frame: 135 days
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
135 days
Part A [CLOVER-1] Progression Free Survival
Time Frame: 135 days
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
135 days
Part A [CLOVER-1] Time to Next Treatment
Time Frame: 3 years
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
3 years
Part A [CLOVER-1] Overall Survival
Time Frame: 135 days
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
135 days
Part A [CLOVER-1] Duration of Response
Time Frame: 135 days
Response assessment per International Uniform Response Criteria for Multiple Myeloma; Lugano Criteria for lymphoma; International Workshop on Chronic Lymphocytic Leukemia for CLL; VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment; or 2005 Response Criteria for CNS Lymphoma
135 days
Part B [CLOVER-WaM] Overall Response Rate
Time Frame: 135 days
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
135 days
Part B [CLOVER-WaM] Treatment Free Survival
Time Frame: 135 days
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
135 days
Part B [CLOVER-WaM] Duration of Response
Time Frame: 135 days
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
135 days
Part B [CLOVER-WaM] Clinical Benefit Rate
Time Frame: 135 days
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
135 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellectar Biosciences, Inc.

Investigators

  • Study Director: Jarrod Longcor, Cellectar Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2017

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimated)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCL-16-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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