A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)

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).

Study Overview

• Status: Completed
• Conditions: Follicular Lymphoma; Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: Rituximab; Drug: 10 MBq/kg Betalutin; Drug: 40 mg lilotomab; Drug: 15 MBq/kg Betalutin; Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab; Drug: 60 mg/m2 lilotomab; Drug: 12.5 mBq/kg Betalutin

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.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Hobart, Australia, 7000
    • Royal Hobart Hospital
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitaet Innsbruck
  • Wien, Austria, 1090
    • Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I
• Belgium
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent (Uz Gent)
  • La Louvière, Belgium
    • CH Jolimont
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • London, Canada, N6A 5W9
    • London Health Sciences Centre
  • Sault Ste Marie, Canada, P6B 0A8
    • Sault Area Hospital
  • Toronto, Canada, M5G 2M
    • Princes Margaret Cancer Centre
• Croatia
  • Zagreb, Croatia, 10 000
    • Clinical Hospital Centre Zagreb
• Czechia
  • Olomouc, Czechia, 779 00
    • University Hospital Olomouc
  • Ostrava-Poruba, Czechia, 708 52
    • FNsP Ostrava
• Denmark
  • Aarhus, Denmark, DK-8000
    • Aarhus Universitetshospital
  • Odense, Denmark, DK-5000
    • Odense Univerisity Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital Comprehensive Cancer Center
  • Jyväskylä, Finland
    • Central Hospital of Central Finland
• France
  • Bordeaux, France
    • Institut Bergonie
  • Grenoble, France
    • CHU Grenoble - Hôpital MICHALLON
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75013
    • AP-HP La pitié Salpêtrière
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud
  • Tours, France
    • Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau
• Hungary
  • Budapest, Hungary
    • Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly
  • Budapest, Hungary
    • Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly
• Ireland
  • Dublin, Ireland
    • Mater Misericordiae University Hospital
  • Dublin, Ireland
    • St James's Hospital
  • Galway, Ireland
    • University Hospital Galway
• Israel
  • Afula, Israel
    • Haemek Medical Center
  • Be'er Ya'aqov, Israel
    • Asaf Harofeh Medical Center
  • Haifa, Israel
    • Bnai Zion Medical Center (BZMC)
  • Haifa, Israel
    • Rambam Health Care Campus (RHCC)
  • Jerusalem, Israel
    • יHadassah Ein Karem Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
• Italy
  • Alessandria, Italy
    • Ss Antonio & Biagio and C. Arrigo Hospital
  • Bologna, Italy, 40138
    • "Istituto di Ematologia ed Oncologia Medica "" L. & A. Seragnoli""-Policlinico S. Orsola Malpighi"
  • Firenze, Italy, 50134
    • Universita Degli Studi Di Firenze-Azienda Ospedaliero-Universitaria Careggi (AOUC)
  • Meldola, Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
  • Milano, Italy
    • Istituto Europeo di Oncologia (IEO)
  • Napoli, Italy
    • "Istituto Nazionale Tumori Fondazione G. Pascale"
  • Reggio Emilia, Italy
    • Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS
  • Torino, Italy
    • AO Ordine Mauriziano di Torino
• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
• Norway
  • Bergen, Norway
    • Haukeland Universitetssjukehus
  • Oslo, Norway, 0310
    • The Norwegian Radium Hospital
  • Trondheim, Norway, 7006
    • St Olav Hospital
• Poland
  • Gdynia, Poland
    • Szpital Morski Im.Pck W Gdynia
  • Krakow, Poland, 50-510
    • Pratia MCM Krakow
  • Warszawa, Poland, 02-097
    • Centrum Onkologii
• Singapore
  • Singapore, Singapore
    • National University Hospital
• Spain
  • Barcelona, Spain
    • Corporacio Sanitaria Parc Tauli
  • Cadiz, Spain
    • Hospital Universitario Puerta del Mar
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Ourense, Spain
    • Complexo Hospitalario Universitario de Ourense
  • Pamplona, Spain
    • Clinica Universidad de Navarra
  • Salamanca, Spain
    • Hospital Clínico Universitario de Salamanca
  • Seville, Spain
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46020
    • Health Research Institute La Fe - Hospital La Fe
  • Valencia, Spain, 46026
    • Hospital Universitario Doctor Peset
• Sweden
  • Umeå, Sweden
    • Cancercentrum -Center of Oncology
• Switzerland
  • Chur, Switzerland
    • Kantonsspital Graubunden
• Turkey
  • Adana, Turkey
    • Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali
  • Ankara, Turkey
    • Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Ankara, Turkey
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic
  • Ankara, Turkey
    • Hacettepe University Oncology Hospital
  • Eskişehir, Turkey
    • Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar
  • Fatih, Turkey
    • Istanbul Universitesi Istanbul Tip Fakultesi
  • Manisa, Turkey
    • Celal Bayar Universitesi Tip Fakultesi
  • Samsun, Turkey
    • Ondokuz Mayis Üniversitesi
  • İzmir, Turkey
    • Ege Universitesi Tip Fakultesi
  • Şehitkamil, Turkey
    • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • Edinburgh, United Kingdom
    • Western General Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West Of Scotland Cancer Centre
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare NHS Trust, Hammersmith Hospital
  • London, United Kingdom
    • University College London Hospitals Nhs Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie Nhs Foundation Trust
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Sutton, United Kingdom
    • The Royal Marsden NHS Foundation Trust
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Dorset Cancer Centre Poole Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • San Francisco, California, United States, 94143
      • University of California, San Francisco (UCSF)
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Part A and Part C:

Inclusion Criteria:

1. 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.
2. Age ≥ 18 years.
3. Part A: A pre-study WHO performance status of 0-1; Part C: WHO performance status of 0-2.
4. Life expectancy should be ≥3 months.
5. <25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
6. Measurable disease by radiological methods.

7. Women of childbearing potential must:

   1. understand that the study medication is expected to have teratogenic risk.
   2. have a negative pregnancy test.
   3. 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.
8. Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months.
9. Patients previously treated with native rituximab are eligible.
10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow up visits and examination.
11. The patient has been fully informed about the study and has signed the informed consent form.

Exclusion Criteria:

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:

1. Absolute neutrophil counts (ANC) ≤1.5×109/L.
2. 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
3. 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).

4. Alkaline phosphatase (ALP) and alanine transaminase (ALT) ≥4×normal level (Part A only).

   Aspartate transaminase (AST), ALT or ALP >2.5×ULN (or >5.0×ULN with liver involvement by primary disease). (Part C only).

5. Creatinine ≥115 µmol/L (men), 97 µmol/L (women) (Part A only). Serum creatinine ≥1.5×ULN (Part C only).

6. 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:

   Inclusion Criteria:

   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:

i. 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:

1. understand that the study medication is expected to have teratogenic risk.
2. have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy test at screening.
3. 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).

ii. 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.

Exclusion Criteria

1. Prior hematopoietic allogenic stem cell transplantation.
2. Patients with a prior autologous SCT are excluded unless at least two years have elapsed since transplantation.
3. 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).
4. Previous total body irradiation.
5. 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)..
6. Patients who are receiving any other investigational medicinal products.
7. Patients with known or suspected CNS involvement of lymphoma.
8. 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:

1. 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.
2. Pulmonary conditions e.g. unstable or uncompensated respiratory disease.
3. Hepatic, renal, neurological, or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
4. 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.
5. History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
6. Cardiac conditions in the previous 24 weeks (before date of consent), including

i. 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.

iii. known uncontrolled arrhythmias (except sinus arrhythmia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Arm 1: 10 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 10 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 10 MBq/kg Betalutin; Drug: 40 mg lilotomab
Experimental: Part A, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 40 mg lilotomab; Drug: 15 MBq/kg Betalutin
Experimental: Part A, Arm 1: 20 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 20 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 40 mg lilotomab; Drug: 20 MBq/kg Betalutin
Experimental: Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing; 10 MBq/kg (based on body weight) Betalutin without pre-dosing	Drug: 10 MBq/kg Betalutin
Experimental: Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing; 15 MBq/kg (based on body weight) Betalutin without pre-dosing	Drug: 15 MBq/kg Betalutin
Experimental: Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing; 15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing	Drug: Rituximab; Drug: 15 MBq/kg Betalutin
Experimental: Part A, Arm 4: 15 MBq/kg Betalutin with higher dose lilotomab pre-dosing; 15 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing	Drug: 15 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Experimental: Part A, Arm 4: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing; 20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing	Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Experimental: Part A, Arm 5: 20 MBq/kg Betalutin with intermediate dose lilotomab pre-dosing; 20 MBq/kg (based on body weight) Betalutin with 60 mg/m2 (based on body surface area) lilotomab pre-dosing	Drug: 20 MBq/kg Betalutin; Drug: 60 mg/m2 lilotomab
Experimental: Part B, Arm 1: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 40 mg lilotomab; Drug: 15 MBq/kg Betalutin
Experimental: Part B, Arm 2: 20 MBq/kg Betalutin with higher dose lilotomab pre-dosing; 20 MBq/kg (based on body weight) Betalutin with 100 mg/m2 (based on body surface area) lilotomab pre-dosing	Drug: 20 MBq/kg Betalutin; Drug: 100 mg/m2 lilotomab
Experimental: Part B, Arm 3: 12.5 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 12.5 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 40 mg lilotomab; Drug: 12.5 mBq/kg Betalutin
Experimental: Part C: 15 MBq/kg Betalutin with lower dose lilotomab pre-dosing; 15 MBq/kg (based on body weight) Betalutin with 40 mg lilotomab pre-dosing	Drug: 40 mg lilotomab; Drug: 15 MBq/kg Betalutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A, Phase I	Number of participants with dose limiting toxicities (DLTs) in Part A	12 weeks
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).	5 years
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	up to 5 years

Collaborators and Investigators

• Sponsor: Nordic Nanovector
• Collaborators: ICON Clinical Research
• Investigators: Study Director: Chris Freitag, Nordic Nanovector

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimated): February 21, 2013

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radioimmunotherapy; Lu-177; Phase I study; Phase II study; Betalutin
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: EudraCT: 2011-000033-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No