AzTrials
AzTrials

Non-Hodgkin LymphomaPhase 1/2LYMRIT-37-01NCT01796171

A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma

A Phase 1/2 study testing 10 MBq/kg Betalutin, 15 MBq/kg Betalutin and 20 MBq/kg Betalutin in people with Non-Hodgkin Lymphoma and Follicular Lymphoma, run by Nordic Nanovector at 96 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma, Follicular Lymphoma
What is being tested?
10 MBq/kg Betalutin, 15 MBq/kg Betalutin and 20 MBq/kg Betalutin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
96 sitesin 24 countries
Study dates
Dec 2012to 27 Oct 2022
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed (by World Health Organization [WHO] classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA (for Part C, this excludes patients meeting Part B criteria, who should enter Part B), marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
  • Age ≥ 18 years.
  • Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2.
  • Life expectancy should be ≥3 months.
  • <25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
  • Measurable disease by radiological methods.
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  • Women of childbearing potential must:
  • understand that the study medication is expected to have teratogenic risk.
  • have a negative pregnancy test.
  • agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea.
  • Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months.
  • Patients previously treated with native rituximab are eligible.
  • The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination.
  • The patient has been fully informed about the study and has signed the informed consent form.
  • Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (grade I IIIA).
  • 2. Male or female aged ≥18 years. 3. Received at least 2 prior systemic anti-neoplastic or immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be a separate line of therapy). Systemic regimens including agents such as idelalisib or other PI3K inhibitors qualify as a prior line of therapy.
  • 4. Prior therapy must have included a rituximab/anti-CD20 agent and an alkylating agent - which may be been administered in separate regimens.
  • 5. Patients must be refractory to any at least one previous regimen that contained rituximab or an anti CD20 agent, with refractoriness defined as:
  • no response (no CR or PR) during therapy, or ii. a response (CR/PR) lasting less than 6 months after the completion of a regimen including rituximab/anti-CD20 therapy (including occurrence of progressive disease (PD) during rituximab/anti-CD20 maintenance therapy, or within 6 months of completion of maintenance therapy).
  • 6. WHO performance status of 0-2. 7. Life expectancy of ≥3 months. 8. Bone marrow tumour infiltration <25% (in biopsy taken from a site not previously irradiated).
  • 9. Measurable disease by CT or MRI: longest diameter (LDi) >1.5 cm for nodal lesion, LDi >1.0 cm for extra nodal lesion on an assessment performed during the screening period.
  • Criteria 10 and 11 must be satisfied within 72 hours of the administration of rituximab:
  • 10. ANC ≥1.5×109/L. 11. Platelet count ≥100×109/L.
  • Criteria 12 to 15 must be verified at time of eligibility review within 2 weeks prior to rituximab administration:
  • 12. Haemoglobin ≥9.0 g/dL. 13. Total bilirubin ≤1.5×upper limit of normal (ULN) (except patients with documented Gilbert's syndrome [<3.0 mg/dL]).
  • 14. Liver enzymes: AST; ALT or ALP ≤2.5×ULN (or ≤5.0×ULN with liver involvement by primary disease).
  • 15. Adequate renal function as demonstrated by a serum creatinine <1.5×ULN. 16. Women of childbearing potential must:
  • understand that the study medication is expected to have teratogenic risk.
  • have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy test at screening.
  • commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin a highly effective method of birth control with a Pearl-Index <1%, without interruption, from 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea. Apart from abstinence, highly effective methods of birth control are: i. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) iii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Vasectomised partner. 17. Male patients must agree to use condoms during intercourse throughout study treatment administration and for 12 months following administration of Betalutin.
  • 18. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination.
  • 19. The patient has been fully informed about the study and has signed the informed consent form.
  • 20. Negative HAMA test at screening. 21. Negative test at screening for Hepatitis B (negative HBsAg and anti-HBc), Hepatitis C and HIV.

Who cannot join

  • Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known to be human immunodeficiency virus (HIV) positive.
  • 2. Laboratory values within 15 days pre-registration:
  • Absolute neutrophil counts (ANC) ≤1.5×109/L.
  • Part A: Platelet count ≤150×109/L; Part C: Platelet count <150×109/L. For Part C, criteria 2a and 2b must be satisfied within 72 hours of the administration of rituximab
  • Total bilirubin ≥30 mmol/L (Part A only). Total bilirubin > 1.5×ULN (except patients with documented Gilbert's syndrome [≥3.0 mg/dL]) (Part C only).
  • Alkaline phosphatase (ALP) and alanine transaminase (ALT) ≥4×normal level (Part A only).
Show all 31Show fewer
  • Aspartate transaminase (AST), ALT or ALP >2.5×ULN (or >5.0×ULN with liver involvement by primary disease). (Part C only).
  • Creatinine ≥115 µmol/L (men), 97 µmol/L (women) (Part A only). Serum creatinine ≥1.5×ULN (Part C only).
  • Haemoglobin <9.0 g/dL (Part C only). 3. Known central nervous system (CNS) involvement of lymphoma. 4. Previous total body irradiation. 5. Positive test for human anti-murine antibody (HAMA) at screening. 6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre treatment with rituximab is allowed.
  • 7. Pregnant or lactating women. 8. Previous hematopoietic stem cell transplantation (autologous and allogenic). 9. Part A: Previous treatment with radioimmunotherapy. Part C: Not applicable. 10. Actively participating in another study or received an IMP within 4 weeks prior to enrolment.
  • 11. Receipt of live-attenuated vaccine within 30 days prior to enrolment. 12. Part A and Part C: Test positive for hepatitis B (HBsAg and anti-HBc). Part C only: Test positive for hepatitis C and human immunodeficiency virus (HIV).
  • 13. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin.
  • Part B:
  • Prior hematopoietic allogenic stem cell transplantation.
  • Patients with a prior autologous SCT are excluded unless at least two years have elapsed since transplantation.
  • Evidence of histological transformation from FL to diffuse large B-cell lymphoma (DLBCL) at time of screening (transformation to grade IIIB that was successfully treated with recurrence of grade I-IIIA initial clone is accepted).
  • Previous total body irradiation.
  • Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other systemic agent including any investigational agent) within 4 weeks prior to start of study treatment (corticosteroid treatment at doses of ≤ 20 mg/day, topical or inhaled corticosteroids, granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor [GM-CSF] are permitted up to 2 weeks prior to start of rituximab)..
  • Patients who are receiving any other investigational medicinal products.
  • Patients with known or suspected CNS involvement of lymphoma.
  • History of malignancy other than FL within 5 years prior to screening( i.e. patients with cancer diagnosed within 5 years prior to screening or who were diagnosed prior to 5 years and were not in CR or were on treatment within 5 years prior to screening), with the exception of malignancies with a negligible risk of metastasis or death (e.g. 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
  • .9. Pregnant or breastfeeding women. 10. Exposure to another CD37 targeting drug. 11. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin.
  • 12. Has received a live-attenuated vaccine within 30 days prior to enrolment. 13. Evidence of severe or uncontrolled systemic diseases:
  • Uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment.
  • Pulmonary conditions e.g. unstable or uncompensated respiratory disease.
  • Hepatic, renal, neurological, or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
  • Psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study.
  • History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
  • Cardiac conditions in the previous 24 weeks (before date of consent), including
  • history of acute coronary syndromes (including unstable angina). ii. class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • known uncontrolled arrhythmias (except sinus arrhythmia).

Trial locations and contacts

96 sites in 24 countries.

96 sites in 24 countries

United States14 sites

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Baylor College of Medicine

    Dallas, Texas, 75246

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University Of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94143

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

Other trials in United States

Turkey (Türkiye)10 sites

  • Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali

    Adana

  • Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic

    Ankara

  • Hacettepe University Oncology Hospital

    Ankara

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar

    Eskişehir

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Fatih

  • Ege Universitesi Tip Fakültesi

    Izmir

  • Celal Bayar Universitesi Tip Fakultesi

    Manisa

  • Ondokuz Mayis Universitesi

    Samsun

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

    Şehitkamil

Other trials in Turkey (Türkiye)

Spain9 sites

  • Corporacio Sanitaria Parc Taulí

    Barcelona

  • Hospital Universitario Puerta del Mar

    Cadiz

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda

  • Complexo Hospitalario Universitario de Ourense

    Ourense

  • Clinica Universidad De Navarra

    Pamplona

  • Hospital Clinico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen Macarena

    Seville

  • Health Research Institute La Fe - Hospital La Fe

    Valencia, 46020

  • Hospital Universitario Doctor Peset

    Valencia, 46026

Other trials in Spain

United Kingdom9 sites

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Western General Hospital

    Edinburgh

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Imperial College Healthcare NHS Trust, Hammersmith Hospital

    London, W12 0HS

  • University College London Hospitals Nhs Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Derriford Hospital

    Plymouth

  • Dorset Cancer Centre Poole Hospital

    Poole, Dorset, BH15 2JB

  • The Royal Marsden NHS Foundation Trust

    Sutton

Other trials in United Kingdom

Italy8 sites

  • SS Antonio & Biagio and C. Arrigo Hospital

    Alessandria

  • "Istituto di Ematologia ed Oncologia Medica "" L. & A. Seragnoli""-Policlinico S. Orsola Malpighi"

    Bologna, 40138

  • Universita Degli Studi Di Firenze-Azienda Ospedaliero-Universitaria Careggi (AOUC)

    Florence, 50134

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

    Meldola

  • Istituto Europeo di Oncologia (IEO)

    Milan

  • "Istituto Nazionale Tumori Fondazione G. Pascale"

    Naples

  • Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia

  • AO Ordine Mauriziano di Torino

    Torino

Other trials in Italy

France6 sites

  • Institut Bergonie

    Bordeaux

  • Chu Grenoble - Hopital Michallon

    Grenoble

  • Hôpital Saint Louis

    Paris, 75010

  • AP-HP La Pitié salpétrière

    Paris, 75013

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

    Tours

Other trials in France

Israel6 sites

  • Haemek Medical Center

    Afula

  • Asaf Harofeh Medical Center

    Be’er Ya‘aqov

  • Bnai Zion Medical Center (BZMC)

    Haifa

  • Rambam Health Care Campus (RHCC)

    Haifa

  • יHadassah Ein Karem Medical Center

    Jerusalem

  • Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Belgium3 sites

  • Universitair Ziekenhuis Gent (UZ Gent)

    Ghent, 9000

  • CH Jolimont

    La Louvière

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • London Health Sciences Centre

    London, N6A 5W9

  • Sault Area Hospital

    Sault Ste. Marie, P6B 0A8

  • Princes Margaret Cancer Centre

    Toronto, M5G 2M

Other trials in Canada

Ireland3 sites

  • Mater Misericordiae University Hospital

    Dublin

  • St James's Hospital

    Dublin

  • University Hospital Galway

    Galway

Other trials in Ireland

Norway3 sites

  • Haukeland Universitetssjukehus

    Bergen

  • The Norwegian Radium Hospital

    Oslo, 0310

  • St Olav Hospital

    Trondheim, 7006

Other trials in Norway

Poland3 sites

  • Szpital Morski Im.Pck W Gdynia

    Gdynia

  • Pratia MCM Kraków

    Krakow, 50-510

  • Centrum Onkologii

    Warsaw, 02-097

Other trials in Poland

South Korea3 sites

  • Chonbuk National University Hospital

    Jeonju

  • Samsung Medical Center

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

Austria2 sites

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I

    Vienna, 1090

Other trials in Austria

Czechia2 sites

  • University Hospital Olomouc

    Olomouc, 779 00

  • FNsP Ostrava

    Ostrava-Poruba, 708 52

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus, DK-8000

  • Odense Univerisity Hospital

    Odense, DK-5000

Other trials in Denmark

Finland2 sites

  • Helsinki University Hospital Comprehensive Cancer Center

    Helsinki

  • Central Hospital Of Central Finland

    Jyväskylä

Other trials in Finland

Hungary2 sites

  • Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly

    Budapest

  • Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly

    Budapest

Other trials in Hungary

Australia1 site

  • Royal Hobart Hospital

    Hobart, 7000

Other trials in Australia

Croatia1 site

  • Clinical Hospital Centre Zagreb

    Zagreb, 10 000

Other trials in Croatia

Netherlands1 site

  • University Medical Center Groningen

    Groningen

Other trials in Netherlands

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

Sweden1 site

  • Cancercentrum -Center of Oncology

    Umeå

Other trials in Sweden

Switzerland1 site

  • Kantonsspital Graubünden

    Chur

Other trials in Switzerland

About this study

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

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).

Read the detailed description

Part A of the study was a Phase 1/2a study to assess the safety and preliminary efficacy of different treatment regimens of Betalutin with expansion at the candidate recommended Phase 2 doses. Part B was a dedicated Phase 2b randomized substudy to further assess the efficacy and safety of the candidate recommended Phase II doses. Part C was a Phase 2a fixed dose expansion cohort planned to obtain supplementary pharmacokinetic data.

Being tested
10 MBq/kg Betalutin, 15 MBq/kg Betalutin, 20 MBq/kg Betalutin, 40 mg lilotomab, 100 mg/m2 lilotomab
Keywords
Radioimmunotherapy, Lu-177, Phase I study, Phase II study, Betalutin
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 MBq/kg BetalutinDrug

  • 15 MBq/kg BetalutinDrug

  • 20 MBq/kg BetalutinDrug

  • 40 mg lilotomabDrug

  • 100 mg/m2 lilotomabDrug

  • 60 mg/m2 lilotomabDrug

  • RituximabDrug

  • 12.5 mBq/kg BetalutinDrug

Study groups in NCT01796171
Study groupRoleWhat they receive
Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 10 MBq/kg Betalutin; Drug: 40 mg lilotomab
Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab
Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 20 MBq/kg Betalutin; Drug: 40 mg lilotomab
Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosingExperimental10 MBq/kg (based on body weight) Betalutin without pre-dosing
Receives: Drug: 10 MBq/kg Betalutin
Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin without pre-dosing
Receives: Drug: 15 MBq/kg Betalutin
Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing
Receives: Drug: 15 MBq/kg Betalutin; Drug: Rituximab
Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Receives: Drug: 15 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Receives: Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosingExperimental20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing
Receives: Drug: 20 MBq/kg Betalutin; Drug: 60 mg/m2 lilotomab
Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab
Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosingExperimental20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing
Receives: Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 40 mg lilotomab; Drug: 12.5 mBq/kg Betalutin
Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosingExperimental15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing
Receives: Drug: 15 MBq/kg Betalutin; Drug: 40 mg lilotomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A, Phase I

    Number of participants with dose limiting toxicities (DLTs) in Part A

    Measured: 12 weeks

  2. Part A, Phase IIa

    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).

    Measured: 5 years

  3. Part B, Phase IIb

    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

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study startDec 2012
  3. Primary completion25 Oct 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796171
Sponsor's protocol ID
EudraCT: 2011-000033-36
Acronym
LYMRIT-37-01
Status last verified
Dec 2023
First submitted
19 Feb 2013
Last updated
21 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dahle J, Repetto-Llamazares AH, Mollatt CS, Melhus KB, Bruland OS, Kolstad A, Larsen RH. Evaluating antigen targeting and anti-tumor activity of a new anti-CD37 radioimmunoconjugate against non-Hodgkin's lymphoma. Anticancer Res. 2013 Jan;33(1):85-95.

    PubMed 23267131

  • Repetto-Llamazares AH, Larsen RH, Mollatt C, Lassmann M, Dahle J. Biodistribution and dosimetry of (177)Lu-tetulomab, a new radioimmunoconjugate for treatment of non-Hodgkin lymphoma. Curr Radiopharm. 2013 Mar;6(1):20-7. doi: 10.2174/1874471011306010004.

    PubMed 23256748

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

  • Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

    PubMed 25113753

  • Larsen RH, Kolstad A, Fossa A, Repetto-Llamazares A, Smerud KT, Illidge T, Bruland OS. A Phase II Study of 177Lu-Lilotomab Satetraxetan, a CD37 Antibody-Radionuclide Conjugate, as Third- or Later-Line Treatment of Rituximab-Refractory Follicular B-Cell Lymphoma Patients. Pharmaceuticals (Basel). 2026 Feb 1;19(2):250. doi: 10.3390/ph19020250.

    PubMed 41754790

  • Londalen A, Blakkisrud J, Revheim ME, Madsbu UE, Dahle J, Kolstad A, Stokke C. 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. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1902-1914. doi: 10.1007/s00259-020-05098-x. Epub 2020 Nov 16.

    PubMed 33196921

  • Kolstad A, Illidge T, Bolstad N, Spetalen S, Madsbu U, Stokke C, Blakkisrud J, Londalen A, O'Rourke N, Beasley M, Jurczak W, Fagerli UM, Kascak M, Bayne M, Obr A, Dahle J, Rojkjaer L, Pascal V, Holte H. Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2020 Sep 8;4(17):4091-4101. doi: 10.1182/bloodadvances.2020002583.

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Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 10 MBq/kg Betalutin, 15 MBq/kg Betalutin and 20 MBq/kg Betalutin in people with Non-Hodgkin Lymphoma and Follicular Lymphoma, run by Nordic Nanovector at 96 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, Turkey (Türkiye), Spain, United Kingdom, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A, Phase I (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01796171, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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