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

Primary Purpose

Waldenstrom Macroglobulinemia, Multiple Myeloma, Chronic Lymphocytic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Iopofosine I 131 single dose
Iopofosine I 131 multiple dose
Iopofosine I 131 fractionated dose
Sponsored by
Cellectar Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

[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)

Sites / Locations

  • Cellectar Biosciences siteRecruiting
  • Cellectar Biosciences siteRecruiting
  • Cellectar Biosciences siteRecruiting
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  • Cellectar Biosciences SiteRecruiting
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  • Cellectar Biosciences siteRecruiting
  • Cellectar Biosciences SiteRecruiting
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  • Cellectar Biosciences siteRecruiting
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  • Cellectar Biosciences siteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Iopofosine I 131, intravenous administration WM

Iopofosine I 131, intravenous administration MM

Iopofosine I 131, intravenous administration CNS Lymphoma

Iopofosine I 131 intravenous administration NHL [CLOSED]

Arm Description

Iopofosine I 131 in Waldenstroms Macroglobulinemia

Iopofosine I 131 in Multiple Myeloma

Iopofosine I 131 in Central Nervous System Lymphoma

Iopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma

Outcomes

Primary Outcome Measures

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
Part B [CLOVER-WaM] Major Response Rate
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment

Secondary Outcome Measures

Part A [CLOVER-1] Overall Response 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
Part A [CLOVER-1] Progression Free Survival
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
Part A [CLOVER-1] Time to Next Treatment
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
Part A [CLOVER-1] Overall Survival
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
Part A [CLOVER-1] Duration of Response
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
Part B [CLOVER-WaM] Overall Response Rate
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Part B [CLOVER-WaM] Treatment Free Survival
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Part B [CLOVER-WaM] Duration of Response
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Part B [CLOVER-WaM] Clinical Benefit Rate
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment

Full Information

First Posted
October 28, 2016
Last Updated
August 18, 2023
Sponsor
Cellectar Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02952508
Brief Title
Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia
Acronym
CLOVER-WaM
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellectar Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iopofosine I 131, intravenous administration WM
Arm Type
Experimental
Arm Description
Iopofosine I 131 in Waldenstroms Macroglobulinemia
Arm Title
Iopofosine I 131, intravenous administration MM
Arm Type
Experimental
Arm Description
Iopofosine I 131 in Multiple Myeloma
Arm Title
Iopofosine I 131, intravenous administration CNS Lymphoma
Arm Type
Experimental
Arm Description
Iopofosine I 131 in Central Nervous System Lymphoma
Arm Title
Iopofosine I 131 intravenous administration NHL [CLOSED]
Arm Type
Experimental
Arm Description
Iopofosine I 131 in Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Iopofosine I 131 single dose
Other Intervention Name(s)
I-131-CLR1404, CLR 131
Intervention Description
Radiopharmaceutical
Intervention Type
Drug
Intervention Name(s)
Iopofosine I 131 multiple dose
Other Intervention Name(s)
I-131-CLR1404, CLR 131
Intervention Description
Radiopharmaceutical
Intervention Type
Drug
Intervention Name(s)
Iopofosine I 131 fractionated dose
Other Intervention Name(s)
I-131-CLR1404, CLR 131
Intervention Description
Radiopharmaceutical
Primary Outcome Measure Information:
Title
Part A [CLOVER-1] Clinical benefit rate
Description
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
Time Frame
84 days
Title
Part B [CLOVER-WaM] Major Response Rate
Description
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Part A [CLOVER-1] Overall Response Rate
Description
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
Time Frame
135 days
Title
Part A [CLOVER-1] Progression Free Survival
Description
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
Time Frame
135 days
Title
Part A [CLOVER-1] Time to Next Treatment
Description
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
Time Frame
3 years
Title
Part A [CLOVER-1] Overall Survival
Description
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
Time Frame
135 days
Title
Part A [CLOVER-1] Duration of Response
Description
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
Time Frame
135 days
Title
Part B [CLOVER-WaM] Overall Response Rate
Description
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Time Frame
135 days
Title
Part B [CLOVER-WaM] Treatment Free Survival
Description
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Time Frame
135 days
Title
Part B [CLOVER-WaM] Duration of Response
Description
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Time Frame
135 days
Title
Part B [CLOVER-WaM] Clinical Benefit Rate
Description
Response assessment per criteria modified from VIth Waldenstrom's Macroglobulinemia Criteria for Response Assessment
Time Frame
135 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Oliver
Phone
608-327-8125
Email
clinical@cellectar.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarrod Longcor
Organizational Affiliation
Cellectar Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Cellectar Biosciences site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences site
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences
City
North Bergen
State/Province
New Jersey
ZIP/Postal Code
07047
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cellectar Biosciences site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40050-410
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Porto Alegre
State/Province
RioGrande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences Site
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences Site
City
Rio
Country
Greece
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences Site
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences site
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site
Facility Name
Cellectar Biosciences
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Bornova
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar Biosciences
Facility Name
Cellectar Biosciences
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Cellectar Biosciences site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cellectar B site

12. IPD Sharing Statement

Learn more about this trial

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

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