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

NCT ID: NCT01796171

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2022-10-27

Brief 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).

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.

Conditions

Non-Hodgkin Lymphoma; Follicular Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

10 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

20 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

Part A, Arm 2: 10 MBq/kg Betalutin with no pre-dosing

10 MBq/kg (based on body weight) Betalutin without pre-dosing

Group Type: EXPERIMENTAL

10 MBq/kg Betalutin

Intervention Type: DRUG

Part A, Arm 2: 15 MBq/kg Betalutin with no pre-dosing

15 MBq/kg (based on body weight) Betalutin without pre-dosing

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

Part A, Arm 3: 15 MBq/kg Betalutin with rituximab pre-dosing

15 MBq/kg (based on body weight) Betalutin with rituximab pre-dosing

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

100 mg/m2 lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

20 MBq/kg Betalutin

Intervention Type: DRUG

100 mg/m2 lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

20 MBq/kg Betalutin

Intervention Type: DRUG

60 mg/m2 lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

20 MBq/kg Betalutin

Intervention Type: DRUG

100 mg/m2 lilotomab

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

40 mg lilotomab

Intervention Type: DRUG

12.5 mBq/kg Betalutin

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

15 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

Interventions

10 MBq/kg Betalutin

Intervention Type: DRUG

15 MBq/kg Betalutin

Intervention Type: DRUG

20 MBq/kg Betalutin

Intervention Type: DRUG

40 mg lilotomab

Intervention Type: DRUG

100 mg/m2 lilotomab

Intervention Type: DRUG

60 mg/m2 lilotomab

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

12.5 mBq/kg Betalutin

Intervention Type: DRUG

Eligibility Criteria

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.

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

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:

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

Nordic Nanovector

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Freitag

Role: STUDY_DIRECTOR

Nordic Nanovector

Locations

University Of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Pacific Shores Medical Group

Long Beach, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Dallas, Texas, United States

Royal Hobart Hospital

Hobart, , Australia

Medizinische Universitaet Innsbruck

Innsbruck, , Austria

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

Vienna, , Austria

Universitair Ziekenhuis Gent (UZ Gent)

Ghent, , Belgium

CH Jolimont

La Louvière, , Belgium

UZ Leuven

Leuven, , Belgium

London Health Sciences Centre

London, , Canada

Sault Area Hospital

Sault Ste. Marie, , Canada

Princes Margaret Cancer Centre

Toronto, , Canada

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

University Hospital Olomouc

Olomouc, , Czechia

FNsP Ostrava

Ostrava-Poruba, , Czechia

Aarhus Universitetshospital

Aarhus, , Denmark

Odense Univerisity Hospital

Odense, , Denmark

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, , Finland

Central Hospital Of Central Finland

Jyväskylä, , Finland

Institut Bergonie

Bordeaux, , France

Chu Grenoble - Hopital Michallon

Grenoble, , France

Hôpital Saint Louis

Paris, , France

AP-HP La Pitié salpétrière

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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

Tours, , France

Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly

Budapest, , Hungary

Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly

Budapest, , Hungary

Mater Misericordiae University Hospital

Dublin, , Ireland

St James's Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

Haemek Medical Center

Afula, , Israel

Asaf Harofeh Medical Center

Be’er Ya‘aqov, , Israel

Bnai Zion Medical Center (BZMC)

Haifa, , Israel

Rambam Health Care Campus (RHCC)

Haifa, , Israel

יHadassah Ein Karem Medical Center

Jerusalem, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

SS Antonio & Biagio and C. Arrigo Hospital

Alessandria, , Italy

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

Bologna, , Italy

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

Florence, , Italy

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

Meldola, , Italy

Istituto Europeo di Oncologia (IEO)

Milan, , Italy

"Istituto Nazionale Tumori Fondazione G. Pascale"

Napoli, , Italy

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , Italy

AO Ordine Mauriziano di Torino

Torino, , Italy

University Medical Center Groningen

Groningen, , Netherlands

Haukeland Universitetssjukehus

Bergen, , Norway

The Norwegian Radium Hospital

Oslo, , Norway

St Olav Hospital

Trondheim, , Norway

Szpital Morski Im.Pck W Gdynia

Gdynia, , Poland

Pratia MCM Kraków

Krakow, , Poland

Centrum Onkologii

Warsaw, , Poland

National University Hospital

Singapore, , Singapore

Chonbuk National University Hospital

Jeonju, , South Korea

Samsung Medical Center

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Corporacio Sanitaria Parc Taulí

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, , Spain

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

Clinica Universidad De Navarra

Pamplona, , Spain

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Health Research Institute La Fe - Hospital La Fe

Valencia, , Spain

Hospital Universitario Doctor Peset

Valencia, , Spain

Cancercentrum -Center of Oncology

Umeå, , Sweden

Kantonsspital Graubünden

Chur, , Switzerland

Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali

Adana, , Turkey (Türkiye)

Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic

Ankara, , Turkey (Türkiye)

Hacettepe University Oncology Hospital

Ankara, , Turkey (Türkiye)

Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar

Eskişehir, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi

Fatih, , Turkey (Türkiye)

Ege Universitesi Tip Fakültesi

Izmir, , Turkey (Türkiye)

Celal Bayar Universitesi Tip Fakultesi

Manisa, , Turkey (Türkiye)

Ondokuz Mayis Universitesi

Samsun, , Turkey (Türkiye)

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

Şehitkamil, , Turkey (Türkiye)

Dorset Cancer Centre Poole Hospital

Poole, Dorset, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, , United Kingdom

University College London Hospitals Nhs Foundation Trust

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Croatia; Czechia; Denmark; Finland; France; Hungary; Ireland; Israel; Italy; Netherlands; Norway; Poland; Singapore; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 23267131 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23256748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17242396 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25113753 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33196921 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32877524 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Part A main SAP

View Document

Document Type: Statistical Analysis Plan: Part A SAP addendum

View Document

Document Type: Statistical Analysis Plan: Part B and C SAP

View Document

Other Identifiers

EudraCT: 2011-000033-36

Identifier Type: -

Identifier Source: org_study_id