NCT01796171 (LYMRIT-37-01) is a Phase 1/Phase 2 clinical trial of 10 MBq/kg Betalutin in Non-Hodgkin Lymphoma, sponsored by Nordic Nanovector.

Who is sponsoring NCT01796171?

NCT01796171 is sponsored by Nordic Nanovector.

What drugs are being tested in NCT01796171?

Interventions in NCT01796171: 10 MBq/kg Betalutin, 15 MBq/kg Betalutin, 20 MBq/kg Betalutin, 40 mg lilotomab, 100 mg/m2 lilotomab, 60 mg/m2 lilotomab, Rituximab, 12.5 mBq/kg Betalutin.

What condition does NCT01796171 study?

NCT01796171 studies Non-Hodgkin Lymphoma, Follicular Lymphoma.

Is NCT01796171 still recruiting?

NCT01796171 is currently completed. Last updated 19 June 2024.

Are results published for NCT01796171?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-19 · How we verify

NCT01796171: LYMRIT-37-01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2 Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

Completed Phase 1/Phase 2 Results posted Last updated 19 June 2024

What this trial tests

Phase 1/Phase 2 trial testing 10 MBq/kg Betalutin in Non-Hodgkin Lymphoma in 191 participants. Completed in 27 October 2022.

Timeline

1 December 2012

Primary endpoint
25 October 2022

27 October 2022

Quick facts

Lead sponsor	Nordic Nanovector
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	191
Start date	1 December 2012
Primary completion	25 October 2022
Estimated completion	27 October 2022
Sites	96 locations across United States, Australia, Austria, Belgium, Canada, Croatia, Czechia, Denmark

Drugs / interventions tested

10 MBq/kg Betalutin — full drug profile →
15 MBq/kg Betalutin
20 MBq/kg Betalutin — full drug profile →
40 mg lilotomab
100 mg/m2 lilotomab
60 mg/m2 lilotomab — full drug profile →
Rituximab — full drug profile →
12.5 mBq/kg Betalutin

Conditions studied

Non-Hodgkin Lymphoma — all drugs for Non-Hodgkin Lymphoma →
Follicular Lymphoma — all drugs for Follicular Lymphoma →

Sponsor

Nordic Nanovector — full company profile →

Who can join

18 and older, any sex, with Non-Hodgkin Lymphoma or Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Part A, Phase I
Time frame: 12 weeks
Number of participants with dose limiting toxicities (DLTs) in Part A
Part A, Phase IIa
Time frame: 5 years
Tumour response rates in patients in Part A receiving Betalutin based on evaluation of CT scan images including PET/CT imaging (and bone marrow biopsy if applicable).
Part B, Phase IIb
Time frame: up to 5 years
Overall response rate in Part B defined as the number of participants with a best response of complete remission or partial remission at any time

Sponsor's own description

This study is a Phase 1/2 open-label three part study in patients with relapsed indolent Non-Hodgkin's lymohoma (NHL) (Parts A and C) or relapsed/refractory follicular lymphoma (FL) (Part B).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Advances in targeted therapy for malignant lymphoma.
Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
Radioimmunotherapy in Oncology: Overview of the Last Decade Clinical Trials.
Rondon A, Rouanet J, Degoul F. · · 2021 · cited 40× · PMID 34771732 · DOI 10.3390/cancers13215570
Monoclonal Antibody Therapies for Hematological Malignancies: Not Just Lineage-Specific Targets.
Cuesta-Mateos C, Alcaraz-Serna A, Somovilla-Crespo B, Muñoz-Calleja C. · · 2017 · cited 39× · PMID 29387053 · DOI 10.3389/fimmu.2017.01936
Aligning physics and physiology: Engineering antibodies for radionuclide delivery.
Tsai WK, Wu AM. · · 2018 · cited 37× · PMID 29537104 · DOI 10.1002/jlcr.3622
Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma.
Kolstad A, Illidge T, Bolstad N, Spetalen S, et al · · 2020 · cited 29× · PMID 32877524 · DOI 10.1182/bloodadvances.2020002583
Targeted alpha therapy for chronic lymphocytic leukaemia and non-Hodgkin's lymphoma with the anti-CD37 radioimmunoconjugate 212Pb-NNV003.
Maaland AF, Saidi A, Torgue J, Heyerdahl H, et al · · 2020 · cited 28× · PMID 32187209 · DOI 10.1371/journal.pone.0230526
Tetraspanin 8 (TSPAN 8) as a potential target for radio-immunotherapy of colorectal cancer.
Maisonial-Besset A, Witkowski T, Navarro-Teulon I, Berthier-Vergnes O, et al · · 2017 · cited 27× · PMID 28423546 · DOI 10.18632/oncotarget.15787
Carrier systems of radiopharmaceuticals and the application in cancer therapy.
Zhang T, Lei H, Chen X, Dou Z, et al · · 2024 · cited 26× · PMID 38195680 · DOI 10.1038/s41420-023-01778-3

Verify or expand the search:

Other trials of 10 MBq/kg Betalutin

Trials testing the same drug.

NCT03806179 — Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL · Phase 1 · completed

Other recruiting trials for Non-Hodgkin Lymphoma

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT07284927 — Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies · Phase 1 · recruiting
NCT06176690 — Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas · Phase 1 · recruiting
NCT07260812 — KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma · Phase 1 · recruiting
NCT06915246 — A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma · Phase 2 · recruiting

Other Nordic Nanovector trials

Trials by the same sponsor.

NCT03806179 — Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL · Phase 1 · completed
NCT02658968 — Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05) · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01796171 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Nordic Nanovector
Last refreshed: 19 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01796171.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing