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Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies

This study is currently recruiting participants.
Verified October 2017 by Cellectar Biosciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02952508
First Posted: November 2, 2016
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma Marginal Zone Lymphoma Mantle-Cell Lymphoma Diffuse Large B Cell Lymphoma Drug: CLR 131 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies

Resource links provided by NLM:


Further study details as provided by Cellectar Biosciences, Inc.:

Primary Outcome Measures:
  • Preliminary efficacy - objective response rate [ Time Frame: 84 days ]

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

Estimated Enrollment: 80
Actual Study Start Date: July 26, 2017
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLR 131, intravenous administration Drug: CLR 131
Radiopharmaceutical
Other Name: I-131-CLR1404

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952508


Contacts
Contact: Kate Oliver 608-327-8125 clinical@cellectar.com

Locations
United States, California
Cellectar Biosciences site Recruiting
Redlands, California, United States, 92373
United States, Florida
Cellectar Biosciences site Recruiting
Jacksonville, Florida, United States, 32224
United States, Illinois
Cellectar Biosciences site Recruiting
Maywood, Illinois, United States, 60153
United States, Louisiana
Cellectar Biosciences site Recruiting
New Orleans, Louisiana, United States, 70121
United States, New York
Cellectar Biosciences site Recruiting
Rochester, New York, United States, 14642
United States, South Carolina
Cellectar Biosciences Recruiting
Greenville, South Carolina, United States, 29605
United States, Washington
Cellectar Biosciences site Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Cellectar Biosciences, Inc.
  More Information

Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02952508     History of Changes
Other Study ID Numbers: DCL-16-001
First Submitted: October 28, 2016
First Posted: November 2, 2016
Last Update Posted: October 31, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia
Leukemia, B-Cell
Lymphoma, Non-Hodgkin