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History of Changes for Study: NCT02952508
Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies
Latest version (submitted August 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 1, 2016 None (earliest Version on record)
2 July 17, 2017 Recruitment Status, Study Status, Oversight, Contacts/Locations and Arms and Interventions
3 August 29, 2017 Study Status and Contacts/Locations
4 October 27, 2017 Study Status and Contacts/Locations
5 January 16, 2018 Study Status and Contacts/Locations
6 March 15, 2018 Outcome Measures, Study Status, Eligibility, Arms and Interventions and Study Description
7 January 7, 2019 Arms and Interventions, Study Status, Study Identification and Eligibility
8 July 22, 2019 Study Status
9 January 17, 2020 Study Status, Arms and Interventions and Eligibility
10 April 7, 2020 Study Status
11 June 17, 2020 Study Status
12 January 27, 2021 Outcome Measures, Arms and Interventions, Study Status, Study Identification, Contacts/Locations, Study Design, Conditions, Study Description and Eligibility
13 August 4, 2021 Outcome Measures, Contacts/Locations, Arms and Interventions, Conditions, Study Description, Study Status and Eligibility
14 September 24, 2021 Contacts/Locations, Study Design and Study Status
15 September 30, 2021 Study Status and Contacts/Locations
16 November 30, 2021 Contacts/Locations and Study Status
17 January 21, 2022 Arms and Interventions, Contacts/Locations, Study Description, Study Status, Study Identification and Eligibility
18 May 5, 2022 Contacts/Locations and Study Status
19 August 3, 2022 Study Status and Contacts/Locations
20 August 11, 2022 Study Status
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Study NCT02952508
Submitted Date:  November 1, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: DCL-16-001
Brief Title: Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies
Official Title: An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Not yet recruiting
Study Start: December 2016
Primary Completion: December 2017 [Anticipated]
Study Completion: March 2018 [Anticipated]
First Submitted: October 28, 2016
First Submitted that
Met QC Criteria:
November 1, 2016
First Posted: November 2, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 1, 2016
Last Update Posted: November 2, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cellectar Biosciences, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study evaluates CLR 131 in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL) who have been previously treated with standard therapy for their underlying malignancy.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Lymphoplasmacytic Lymphoma
Marginal Zone Lymphoma
Mantle-Cell Lymphoma
Diffuse Large B Cell Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CLR 131, intravenous administration Drug: CLR 131
Other Names:
  • I-131-CLR1404
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Preliminary efficacy - objective response rate
[ Time Frame: 84 days ]

Secondary Outcome Measures:
1. Preliminary efficacy - time to progression
[ Time Frame: 84 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

All Patients

  • Histologically or cytologically confirmed MM; CLL/SLL, LPL, MZL; or MCL OR histologically proven, de novo, DLBCL
  • ECOG performance status of 0 to 2
  • 18 years of age or older
  • Life expectancy of at least 6 months
  • Platelets ≥ 100,000/µL (if full-dose anticoagulation therapy is used, platelets ≥ 150,000/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
  • Alanine aminotransferase < 3 × 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
  • Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
  • Patient or his or her legal representative has the ability to read, understand, and provide written informed consent for the initiation of any study-related procedures
  • Female patients of childbearing potential must have a negative pregnancy test within 24 hours of enrollment
  • Women of childbearing potential and men who are able to father a child must agree to use an effective method of contraception (eg, oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 12 months following administration of the study drug

Patients with Multiple Myeloma

  • At least 2 prior regimens and no more than 5, which must include at least 1 approved proteasome inhibitor (bortezomib or carfilzomib) and at least 1 approved immunomodulatory agent (thalidomide, lenalidomide, or pomalidomide), with or without maintenance therapy, unless patients are ineligible to receive such agents.
  • Bone marrow biopsy within 28 days of CLR 131 infusion demonstrating at least 5% plasma cell involvement
  • Progressive disease defined by any of the following:
    • 25% 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%.
    • New onset hypercalcemia > 11.5 mg/dL
  • 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.
    • Measurable plasmacytoma
  • Patients who are non-secretors will be considered for accrual on a case-by-case basis by the Sponsor and will require an Investigator plan to define PD prior to enrollment and to assess clinical benefit after treatment.

Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, or Marginal Zone Lymphoma

  • Prior treatment with at least 2 and no more than 4 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

Patients with Mantle Cell Lymphoma

  • Prior treatment with at least 1 and no more than 2 prior regimens
  • 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 Diffuse Large B-Cell Lymphoma

  • Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline. 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.
  • One additional therapy or stem cell transplant for DLBCL is allowed.
  • At least 1 measurable nodal lesion with longest diameter > 15 mm or 1 measurable extranodal lesion (eg, hepatic nodule) with longest diameter > 10 mm

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
  • Extradural tumor in contact with the spinal cord or tumor located where swelling in response to therapy may impinge upon the spinal cord
  • Central nervous system involvement unless previously treated with surgery or radiotherapy with the patient neurologically stable and off corticosteroids
  • 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)
  • PTT > 1.3 × ULN
  • INR > 2.5
  • Radiation therapy, chemotherapy, immunotherapy, or investigational therapy within 2 weeks of eligibility-defining bone marrow biopsy.
  • History of hypersensitivity to iodine
  • Any other concomitant serious illness or organ system dysfunction that in the opinion of the Investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug including, but not limited to, myelodysplastic syndromes; New York Heart Association class III-IV heart disease; unstable angina pectoris; serious cardiac arrhythmia requiring medication or a pacemaker/automatic implantable cardioverter defibrillator; myocardial infarction within the past 6 months; uncontrolled hypertension; severe peripheral vascular disease; ongoing hemodialysis or peritoneal dialysis; poorly controlled severe chronic obstructive pulmonary disease; ongoing/active infection requiring antibiotics; and uncontrolled hypothyroidism or hyperthyroidism
  • Major surgery within 6 weeks of enrollment
  • Known history of human immunodeficiency virus, hepatitis C, or hepatitis B infection
  • Pregnancy or breast-feeding
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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