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Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas

Study acronym: CLOVER-2
StatusActive, Not Recruiting
PhasePhase 1
Started2019-04-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Aug 25, 2026 → Jun 30, 2027
See other at-risk trials from Cellectar Biosciences, Inc.

Amendment history

2026-10-02
Primary completion pushed: 2026-08-25 → 2027-06-30
Completion pushed: 2027-02-25 → 2027-12
2026-03-16
Study Identification, Study Status v20
Primary completion date2025-12-25→2026-08-25
Completion date2026-12→2027-02-25
Study title-96 characters
Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults WithPediatric Relapsed or /Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and OsteosarcomaSarcomas
2025-03-25
Study Status v19
Primary completion date2022-09-25→2025-12-25
Completion date2024-12→2026-12
2023-05-16
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v18
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 8 of 8 sites
2023-02-21
Study Status, Contacts/Locations v17
Primary completion dateestimated 2022-09→confirmed 2022-09-25
Study sites7→8
Show 16 earlier versions
2021-11-30
Study Status, Contacts/Locations v16
Re-verified, no change to tracked fields
2021-08-03
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 7 sites
2021-07-23
Study Status, Contacts/Locations v14
Study sites5→7
2021-03-16
Study Status, Outcome Measures v13
Secondary endpointsdetails revised at 2 of 6 entries
2021-03-15
Study Identification, Study Status, Study Description, Outcome Measures, Eligibility v12
Primary completion date2020-09→2022-09
Completion date2020-12→2024-12
Eligibility criteria-390 characters
[...] re are no standard treatment options with curative potential. Note: patients with diffuse intrinsic pontine glioma (DIPG) may enroll without histological or cytological confirmation. ≥ 2 years of age and ≤ 2125 years of age at time of consent/assent If ≥ age 16 years, K [...] and dosing) Absolute neutrophil count ≥ 750/µL Hemoglobin ≥ 108 g/dL (last transfusion must be at least 1 week prior to stu [...] N Bilirubin < 2 × ULN Patients who have undergone autologous or allogeneic bone marrow transplant must be at least 3 months from trans [...] istration. At minimum, 2 x 10^6/kg cryopreserved CD34+ cells/kg must be a [...] [...]
Secondary endpoints1 to 6 entries
Identification of recommended phase 2 dose of CLR 131 in children, adolescents, and young adults Determination of preliminary antitumor activity of CLR 131 in children, adolescents, and young adults Determination of therapeutic activity of CLR 131 in children, adolescents, and young adults Determination of event free survival following CLR 131 infusion in children, adolescents, and young adults Determination of overall survival following CLR 131 infusion in children, adolescents, and young adults Determine dosimetry of CLR 131 in children, adolescents, and young adults
Study title+15 characters
Dose Escalation Study of CLR 131 in Children, Adolescents, and AdolescentsYoung Adults With Relapsed or Refractory Malignant Tumors Including But [...]
2020-02-24
Study Status, Contacts/Locations v11
Study sites4→5
2020-01-20
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 4 sites
2019-12-17
Study Status, Contacts/Locations v9
Study sites2→4
2019-12-03
Study Status, Contacts/Locations v8
Study sites1→2
2019-10-31
2 amendments v6-v7
2 re-verifications since 2019-09-11, no change to tracked fields
2019-07-05
Study Identification, Study Status, Arms and Interventions, Eligibility v5
Start dateestimated 2019-03-14→confirmed 2019-04-30
Eligibility criteria+411 characters
[...] and ≤ 21 years of age at time of consent/assent If ≥ age 16 years, Karnofsky performance status of ≥ 60. If < age 16 years, Lansky performance status ≥ 60 Platelets ≥ 75,000/µL (last [...] egistration and dosing) Using the bedside Schwartz formula, age-basedestimated serumGFR (creatinine withinclearance) 2> x60 upper limit of normal (ULN)ml/min/1.73m2 Alanine aminotransferase < 3 × ULN Bilirubin < 2 × ULN Pati [...] be at least 3 months from transplant. Patients enrolling at total dose levels > 30 millicurie (mCi)/m2 must have availability or ability to collect an autologous hematopoietic stem cell back-u [...] [...]
Study title+22 characters
Dose Escalation Study of CLR 131 in Children and Adolescents With Relapsed or Refractory Malignant BrainTumors Cancer,Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma
2019-03-19
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2019-03-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2019-03-15
Study Status, Contacts/Locations v2
Start date2019-01→2019-03-14
Study sitescontacts updated at 1 of 1 site
2018-12-20
Study Status v1
Start date2018-07→2019-01
2018-03-26
Original filing
The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.
Trial Details
NCT Number NCT03478462
Lead Sponsor Cellectar Biosciences, Inc.
Conditions Pediatric Solid Tumor, Pediatric Lymphoma, Pediatric Brain Tumor, DIPG, Neuroblastoma, Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma
Enrollment 30 participants
Start Date 2019-04-30
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-10-01