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

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

This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B and C, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study.

Study Overview

• Status: Active, not recruiting
• Conditions: Follicular Lymphoma; Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: Betalutin; Drug: Betalutin; Drug: Betalutin; Drug: Betalutin; Drug: Betalutin; Drug: Betalutin

• 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 Bergonié
  • Grenoble, France
    • CHU Grenoble - Hopital 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
    • Corporació Sanitària Parc Taulí
  • 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 Clinico 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 Graubünden
• 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 Universitesi
  • 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
• Genders Eligible for Study: All

Description

Part A and Part C:

Inclusion Criteria:

• Histologically confirmed (by WHO classification) relapsed incurable non- Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA, marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
• Age ≥ 18 years
• A pre-study WHO performance status of 0-1
• Life expectancy should be ≥ 3 months
• <25% tumour cells in bone marrow biopsy
• Measurable disease by radiological methods

Exclusion Criteria:

• Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l
• Platelet count ≤ 150 x 109 /l
• Total bilirubin ≥ 30 mmol/l
• ALP and ALAT ≥ 4x normal level
• Creatinine ≥ 115 µmol/l (men), 97 µmol/l (women))
• Known CNS involvement of lymphoma
• Previous total body irradiation
• Known history of HAMA
• Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pretreatment with rituximab is allowed
• Previous hematopoietic stem cell transplantation (autologous and allogenic)
• Previous treatment with radioimmunotherapy
• Receipt of live, attenuated vaccine within 30 days prior to enrolment
• Test positive for hepatitis B (HBsAg and anti-HBc)
• A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin

Part B:

Inclusion Criteria:

Histologically confirmed (by WHO classification) relapsed non-Hodgkin B-cell FL (follicular grade I-IIIA).

2. Male or female aged ≥ 18 years. 3. Received at least 2 prior anti-neoplastic or immunotherapy-based regimens (maintenance therapy following a CR/PR is not considered to be a separate line of therapy).

4. Prior therapy must include rituximab/anti-CD20 agent and an alkylating agent. Prior exposure to other systemic anti-neoplastic agents (including idelalisib or other phosphatidylinositol 3-kinase (PI3K) inhibitors etc.) is also allowed.

5. Patients must be refractory to any previous regimen containing rituximab or an anti-CD20 agent, defined as: no response (no CR/PR) during therapy, or 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 within 28 days prior to start of treatment.

10. ANC ≥ 1.5 x 109/L. 11. Platelet count ≥ 100 x 109/L . 12. Haemoglobin ≥ 9.0 g/dL. 13. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome [< 3.0 mg/dL]).

14. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or ALP ≤ 2.5 x ULN (or ≤ 5.0 x ULN with liver involvement by primary disease).

15. Adequate renal function as demonstrated by a serum creatinine < 1.5 x 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 medication therapy and the following 12 months.

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 Hepatitis B (negative HBsAG and anti-HBC), Hepatitis C and HIV test at screening

Exclusion Criteria:

Prior hematopoietic allogenic stem cell transplantation. Patients with a prior autologous stem cell transplanted (SCT) are excluded unless at least two years have elapsed since transplantation and the patient has been without grade ≥1 Graft vs Host Disease (GvHD) in the 8 weeks before date of consent.

3. Evidence of histological transformation from FL to diffuse large B-cell lymphoma (DLBCL) at time of screening. 4. Previous total body irradiation. 5. Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other 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 study treatment). Note: excludes pre-treatment with rituximab as part of this study.

6. Patients who are receiving any other investigational medicinal products. 7. Patients with known or suspected CNS involvement of lymphoma. 8. History of a previous treated cancer except for the following:

a. adequately treated local basal cell or squamous cell carcinoma of the skin. b. cervical carcinoma in situ. c. superficial bladder cancer. d. localised prostate cancer undergoing surveillance or surgery. e. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy.

f. other adequately treated Stage 1 or 2 cancer currently in CR. 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: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Arm 1: with lilotomab pre-dosing; Betalutin, 10 MBq/kg b.w. in escalated doses with lilotomab pre-dosing. COMPLETED enrolment into this arm	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
Experimental: Part A, Arm 2: without pre-dosing; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing. COMPLETED enrolment into this arm	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
Experimental: Part A, Arm 3: with rituximab pre-dosing; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing. COMPLETED enrolment into this arm	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
Experimental: Part A, Arm 4: with higher dose lilotomab pre-dosing; Betalutin, 15 MBq/kg b.w. in escalated doses with a higher dose lilotomab pre-dosing regimen. COMPLETED enrolment into this arm	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
Experimental: Part A, Arm 5: with intermediate dose lilotomab pre-dosing; Betalutin, 20 MBq/kg b.w. with an intermediate dose lilotomab pre-dosing regimen. COMPLETED enrolment into this arm	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
Experimental: Part B and Part C; Available dosing arm - '40/15' Completed enrolment	Drug: Betalutin; Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing; Drug: Betalutin; Betalutin, 15 MBq/kg b.w. with 40mg lilotomab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A, Phase I	To define Maximum tolerated dose (MTD) of Betalutin Adverse events and abnormal laboratory values will be graded for toxicity according to CTCAE version 4.	12 weeks
Part A, Phase IIa	To explore tumour response rates in patients receiving Betalutin	3 months - 5 years
Part B, Phase IIb	Overall response rate	3 months - 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.
• Løndalen 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 (177)Lu-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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

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
• 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