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Radioimmunotherapy

Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing for Non-Hodgkin's Lymphoma (LYMRIT-37-01 Trial)

Phase 1 & 2
Waitlist Available
Led By Arne Kolstad, MD, PhD
Research Sponsored by Nordic Nanovector
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

LYMRIT-37-01 Trial Summary

This trial is testing a new cancer treatment in patients who have indolent NHL or FL that has relapsed or is refractory. The trial has four parts. The first part is to test for safety and preliminary efficacy. The second part is to expand the dose. The third part is to refine the dose. The fourth part is to test the single-arm.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Follicular Lymphoma

LYMRIT-37-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A, Phase I
Part A, Phase IIa
Part B, Phase IIb

LYMRIT-37-01 Trial Design

13Treatment groups
Experimental Treatment
Group I: Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Group II: Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Group III: Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental Treatment2 Interventions
20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Group IV: Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Group V: Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosingExperimental Treatment2 Interventions
20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing
Group VI: Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental Treatment2 Interventions
20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Group VII: Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental Treatment2 Interventions
15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Group VIII: Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosingExperimental Treatment2 Interventions
15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing
Group IX: Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosingExperimental Treatment1 Intervention
15 MBq/kg (based on body weight) Betalutin without pre-dosing
Group X: Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosingExperimental Treatment1 Intervention
10 MBq/kg (based on body weight) Betalutin without pre-dosing
Group XI: Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Group XII: Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Group XIII: Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental Treatment2 Interventions
10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
12.5 mBq/kg Betalutin
2012
Completed Phase 2
~200
20 MBq/kg Betalutin
2012
Completed Phase 2
~200
60 mg/m2 lilotomab
2012
Completed Phase 2
~200
10 MBq/kg Betalutin
2012
Completed Phase 2
~200
40 mg lilotomab
2012
Completed Phase 2
~200
15 MBq/kg Betalutin
2012
Completed Phase 2
~200
Rituximab
1999
Completed Phase 4
~1880
100 mg/m2 lilotomab
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Nordic NanovectorLead Sponsor
3 Previous Clinical Trials
25 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
15,181 Total Patients Enrolled
Arne Kolstad, MD, PhDPrincipal InvestigatorOslo University Hospital
1 Previous Clinical Trials
14 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
European Journal of Nuclear Medicine and Molecular ImagingJournal
FDG PET/CT Parameters and Correlations with Tumor-absorbed Doses in a Phase 1 Trial of 177lu-lilotomab Satetraxetan for Treatment of Relapsed Non-hodgkin Lymphoma
Løndalen, Ayca, Johan Blakkisrud, Mona-Elisabeth Revheim, Ulf Erik Madsbu, Jostein Dahle, Arne Kolstad, and Caroline Stokke. 2020. “FDG PET/CT Parameters and Correlations with Tumor-absorbed Doses in a Phase 1 Trial of 177lu-lilotomab Satetraxetan for Treatment of Relapsed Non-hodgkin Lymphoma”. European Journal of Nuclear Medicine and Molecular Imaging. Springer Science and Business Media LLC. doi:10.1007/s00259-020-05098-x.
Blood AdvancesJournal
Phase 1/2a Study of 177lu-lilotomab Satetraxetan in Relapsed/refractory Indolent Non-hodgkin Lymphoma
Kolstad, Arne, Tim Illidge, Nils Bolstad, Signe Spetalen, Ulf Madsbu, Caroline Stokke, Johan Blakkisrud, et al.. 2020. “Phase 1/2a Study of 177lu-lilotomab Satetraxetan in Relapsed/refractory Indolent Non-hodgkin Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002583.
European Journal of HaematologyJournal
Combination Of<sup>177</sup>lu-lilotomab with Rituximab Significantly Improves the Therapeutic Outcome in Preclinical Models of Non-hodgkin's Lymphoma
Repetto-Llamazares, Ada H. V., Marion M. Malenge, Adam O'Shea, Bergthóra Eiríksdóttir, Trond Stokke, Roy H. Larsen, and Jostein Dahle. 2018. “Combination Of177lu-lilotomab with Rituximab Significantly Improves the Therapeutic Outcome in Preclinical Models of Non-hodgkin's Lymphoma”. European Journal of Haematology. Wiley. doi:10.1111/ejh.13139.
Current RadiopharmaceuticalsJournal
Biodistribution and Dosimetry of 177lu-tetulomab, a New Radioimmunoconjugate for Treatment of Non-hodgkin Lymphoma
H. V. Repetto-Llamazares, Ada, Roy H. Larsen, Camilla Mollatt, Michael Lassmann, and Jostein Dahle. 2013. “Biodistribution and Dosimetry of 177lu-tetulomab, a New Radioimmunoconjugate for Treatment of Non-hodgkin Lymphoma”. Current Radiopharmaceuticals. Bentham Science Publishers Ltd.. doi:10.2174/1874471011306010004.
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