Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02658968 |
Recruitment Status :
Completed
First Posted : January 20, 2016
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Relapsed, Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma | Drug: Betalutin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Dose Finding Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) in Patients With Relapsed/Refractory, Diffuse Large B-cell Lymphoma, Not Eligible for Autologous Stem Cell Transplant |
Actual Study Start Date : | March 2, 2017 |
Actual Primary Completion Date : | June 4, 2021 |
Actual Study Completion Date : | July 10, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Betalutin
10 MBq/kg b.w., in escalated doses with lilotomab pre-dosing
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Drug: Betalutin
Dose finding study, starting on 10 MBq/kg b.w. Betalutin® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.
Other Name: Betalutin, lutetium (177Lu)-lilotomab satetraxetan |
- Determine the Maximum Tolerated Dose [ Time Frame: 12 weeks ]To determine the maximum tolerated dose of Betalutin that can be given to patients with relapsed/refractory, diffuse large B-cell lymphoma, not eligible for autologous stem cell transplant.
- The best overall tumour response rate [ Time Frame: 3 months - 2 years ]Efficacy evaluations are measured by tumour response rates using CT and PET/CT imaging with responses classified according to revised response criteria for NHL (Cheson, 2014).
- Dosimetry [ Time Frame: 3 weeks ]Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female aged ≥18 years.
- Histologically confirmed DLBCL (WHO classification).
- Received at least one prior line of therapy including immuno-chemotherapy.
- In first or subsequent relapse, or refractory to the last treatment (defined as less than a complete metabolic response to the last treatment, or within 6 months from the last treatment).
- Not suitable for, or declined high dose chemotherapy and autologous stem cell transplantation (ASCT).
- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (at least one objectively bi-dimensionally measurable (nodal) lesion (>2 cm in its largest dimension by CT scan).
- Negative human anti-murine antibody (HAMA) test.
- Life expectancy of at least 3 months.
- Bone marrow tumour infiltration <25% tumour cells.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
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Normal organ and bone marrow function defined as:
- Absolute neutrophil count ≥1.5 x 109/L;
- Platelet count ≥150 x 109/L;
- Haemoglobin ≥9 g/dL;
- Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome);
- Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN if liver involvement by primary disease);
- Adequate renal function as demonstrated by a serum creatinine ≤1.5 mg/dL or a creatinine clearance >60 mL/min;
- Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ≤1.3 ULN range acceptable).
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Women of childbearing potential must
- understand that the study medication may have teratogenic risk
- have a negative serum pregnancy test at screening and before Betalutin injection
-
commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ≤ 1%. without interruption from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are:
- Combined (estrogen 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
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system ( IUS)
- Bilateral tubal occlusion
- Vasectomised partner
- Male patients must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
- Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
- Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
- A negative Hepatitis B test (HBsAg and anti-HBc) and negative HIV test during screening
Exclusion Criteria:
- Prior hematopoietic allogenic stem cell transplantation.
- Prior autologous stem cell transplantation.
- Previous total body irradiation, or irradiation of >25% of the patient's bone marrow.
- 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, G-CSF or GM CSF are permitted up to 2 weeks prior to start of study treatment.). Note: excluding pre-treatment with rituximab as part of this study
- Patients who are receiving any other investigational agents.
- Patients with known or suspected central nervous system involvement of lymphoma.
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History of a previous treated cancer except for the following:
- adequately treated local basal cell or squamous cell carcinoma of the skin;
- cervical carcinoma in situ;
- superficial bladder cancer;
- localized prostate cancer undergoing surveillance or surgery;
- localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy;
- other adequately treated Stage 1 or 2 cancer currently in complete remission;
- Pregnant or breastfeeding women.
- Exposure to another CD37 targeting drug.
- Allergy to X ray contrast agents.
- A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin.
- Has received a live attenuated vaccine within 30 days prior to enrolling in the study.
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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;
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cardiac conditions, including
- history of acute coronary syndromes (including unstable angina)
- 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) in the past 24 weeks.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658968
United States, California | |
University of California, San Diego (UCSD) - Moores Cancer Center | |
San Diego, California, United States, 92093 | |
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances | |
San Francisco, California, United States, 94117 | |
United States, Florida | |
Sylvester Comprehensive Cancer Centre | |
Miami, Florida, United States, 33146 | |
Germany | |
Klinikum rechts der Isar der TU München | |
Munich, Germany, 81675 | |
Italy | |
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi | |
Bologna, Italy, 40138 | |
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino | |
Torino, Italy, 10126 | |
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento | |
Verona, Italy, 37134 | |
Spain | |
Hospital Universitari i Politècnic La Fe | |
Valencia, Spain, 46026 | |
United Kingdom | |
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre | |
Bristol, United Kingdom, BS2 8ED | |
Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 4BX |
Principal Investigator: | Timothy Illidge, PhD MB BS | University of Manchester, The Christie NHS Foundation Trust |
Responsible Party: | Nordic Nanovector |
ClinicalTrials.gov Identifier: | NCT02658968 |
Other Study ID Numbers: |
EudraCT: 2015-001933-26 |
First Posted: | January 20, 2016 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Betalutin Radioimmunotherapy Lu-177 Phase I study ARC Antibody Radionuclide Conjugate HH1 Rituximab 177Lu-DOTA-HH1 Lilotomab Lutetium (177Lu)-lilotomab satetraxetan Additional relevant MeSH terms: |
Lymphoma Lymphoma, Non-Hodgkin Immune System Diseases Immunoproliferative Disorders Diffuse Large B-Cell Lymphoma Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type DLBCL Refractory DLBCL Relapsed DLBCL |
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |