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

NCT02952508 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: DCL-16-001
• Study Type: interventional
• Target: 120
• Locations: 11 countries
• Sites: 52

Brief Summary

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.

Conditions

Waldenstrom Macroglobulinemia; Multiple Myeloma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma; Central Nervous System Lymphoma

Keywords

Waldenstrom Macroglobulinemia; Non-Hodgkin Lymphoma; NHL; Relapsed; Refractory; Novel class; Pivotal; Phase 3; Hematologic disease; Neoplasm; Plasma cell neoplasms; Paraproteinemias; Lymphoma; Immunoproliferative disorder; Blood protein disorders; Lymphoproliferative disorders; Antineoplastic agents

Outcome Measures

Primary Outcomes (2)

• Part A [CLOVER-1] Clinical benefit rate

  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

  Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment

  12 months

Secondary Outcomes (9)

• Part A [CLOVER-1] Overall Response Rate

  135 days

• Part A [CLOVER-1] Progression Free Survival

  135 days

• Part A [CLOVER-1] Time to Next Treatment

  3 years

• Part A [CLOVER-1] Overall Survival

  135 days

• Part A [CLOVER-1] Duration of Response

  135 days

Study Arms (4)

Iopofosine I 131, intravenous administration WM

EXPERIMENTAL

Iopofosine I 131 in Waldenstroms Macroglobulinemia

Drug: Iopofosine I 131 single dose; Drug: Iopofosine I 131 multiple dose; Drug: Iopofosine I 131 fractionated dose

Iopofosine I 131, intravenous administration MM

EXPERIMENTAL

Iopofosine I 131 in Multiple Myeloma

Drug: Iopofosine I 131 single dose; Drug: Iopofosine I 131 multiple dose; Drug: Iopofosine I 131 fractionated dose

Iopofosine I 131, intravenous administration CNS Lymphoma

EXPERIMENTAL

Iopofosine I 131 in Central Nervous System Lymphoma

Drug: Iopofosine I 131 fractionated dose

Iopofosine I 131 intravenous administration NHL [CLOSED]

EXPERIMENTAL

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; Drug: Iopofosine I 131 multiple dose; Drug: Iopofosine I 131 fractionated dose

Interventions

Iopofosine I 131 single dose DRUG

Radiopharmaceutical

Also known as: I-131-CLR1404, CLR 131

Iopofosine I 131 intravenous administration NHL [CLOSED]; Iopofosine I 131, intravenous administration MM; Iopofosine I 131, intravenous administration WM

Iopofosine I 131 multiple dose DRUG

Radiopharmaceutical

Also known as: I-131-CLR1404, CLR 131

Iopofosine I 131 intravenous administration NHL [CLOSED]; Iopofosine I 131, intravenous administration MM; Iopofosine I 131, intravenous administration WM

Iopofosine I 131 fractionated dose DRUG

Radiopharmaceutical

Also known as: I-131-CLR1404, CLR 131

Iopofosine I 131 intravenous administration NHL [CLOSED]; Iopofosine I 131, intravenous administration CNS Lymphoma; Iopofosine I 131, intravenous administration MM; Iopofosine I 131, intravenous administration WM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed MM; Patients with primary or secondary CNSL may be enrolled.
• ECOG performance status of 0 to 2
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cellectar Biosciences, Inc.: lead

Study Sites (52)

Cellectar Biosciences site

Los Angeles, California, 90095, United States

Location

Cellectar Biosciences site

Redlands, California, 92373, United States

Location

Cellectar Biosciences site

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

Location

Cellectar Biosciences site

Jacksonville, Florida, 32224, United States

Location

Cellectar Biosciences site

Miami, Florida, 33165, United States

Location

Cellectar Biosciences site

Tampa, Florida, 33612, United States

Location

Cellectar Biosciences

Atlanta, Georgia, 30332, United States

Location

Cellectar Biosciences site

Maywood, Illinois, 60153, United States

Location

Cellectar Biosciences site

Warrenville, Illinois, 60555, United States

Location

Cellectar Biosciences site

Westwood, Kansas, 66205, United States

Location

Cellectar Biosciences site

New Orleans, Louisiana, 70121, United States

Location

Cellectar Biosciences site

Baltimore, Maryland, 21287, United States

Location

Cellectar Biosciences

Bethesda, Maryland, 20817, United States

Location

Cellectar Biosciences site

Boston, Massachusetts, 02215, United States

Location

Cellectar Biosciences

North Bergen, New Jersey, 07047, United States

Location

Cellectar Biosciences site

Buffalo, New York, 14263, United States

Location

Cellectar Biosciences site

New York, New York, 10065, United States

Location

Cellectar Biosciences site

Rochester, New York, 14642, United States

Location

Cellectar Biosciences site

Durham, North Carolina, 27705, United States

Location

Cellectar Biosciences

Canton, Ohio, 44718, United States

Location

Cellectar Biosciences site

Cincinnati, Ohio, 45219, United States

Location

Cellectar Biosciences Site

Charleston, South Carolina, 29425, United States

Location

Cellectar Biosciences

Greenville, South Carolina, 29605, United States

Location

Cellectar Biosciences site

Knoxville, Tennessee, 37920, United States

Location

Cellectar Biosciences site

Dallas, Texas, 75246, United States

Location

Cellectar Biosciences site

Dallas, Texas, 75390, United States

Location

Cellectar Biosciences site

Houston, Texas, 77030, United States

Location

Cellectar Biosciences site

Seattle, Washington, 98109, United States

Location

Cellectar Biosciences site

Madison, Wisconsin, 53792, United States

Location

Cellectar Biosciences site

Concord, New South Wales, 2139, Australia

Location

Cellectar Biosciences

Adelaide, South Australia, 5000, Australia

Location

Cellectar Biosciences

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Cellectar Biosciences

Curitiba, Paraná, 80810-050, Brazil

Location

Cellectar Biosciences

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

Location

Cellectar Biosciences

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Cellectar Biosciences Site

Hradec Králové, 500 05, Czechia

Location

Cellectar Biosciences

Helsinki, 00029, Finland

Location

Cellectar Biosciences

Pessac, 33600, France

Location

Cellectar Biosciences

Poitiers, 86021, France

Location

Cellectar Biosciences site

Athens, 115 28, Greece

Location

Cellectar Biosciences Site

Rio, Greece

Location

Cellectar Biosciences Site

Jerusalem, Israel

Location

Cellectar Biosciences

Barcelona, 08036, Spain

Location

Cellectar Biosciences site

Barcelona, 08908, Spain

Location

Cellectar Biosciences

Madrid, 28027, Spain

Location

Cellectar Biosciences

Madrid, 28040, Spain

Location

Cellectar Biosciences

Salamanca, 37007, Spain

Location

Cellectar Biosciences site

Zaragoza, 50009, Spain

Location

Cellectar Biosciences

Ankara, 06620, Turkey (Türkiye)

Location

Cellectar Biosciences

Bornova, 35100, Turkey (Türkiye)

Location

Cellectar Biosciences

Istanbul, 34093, Turkey (Türkiye)

Location

Cellectar Biosciences site

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Recurrence; Hematologic Diseases; Neoplasms; Neoplasms, Plasma Cell; Paraproteinemias; Lymphoma; Immunoproliferative Disorders; Blood Protein Disorders; Lymphoproliferative Disorders

Interventions

CLR1404

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphatic Diseases; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Study Officials

• Jarrod Longcor

  Cellectar Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 2, 2016
• Study Start: July 26, 2017
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): December 22, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

ES (6); TU (3); BR (4); IL (1); AU (2); GR (2); FR (2); US (29); CZ (1); FI (1); GB (1)