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Non Hodgkin LymphomaPhase 1LYMRIT-37-07NCT03806179

Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL

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

Completed

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

Official record
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Trial summary

This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
10 MBq/kg Betalutin and 15 MBq/kg Betalutin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesin 2 countries
Study dates
4 Oct 2018to 8 Aug 2022
Phase
Phase 1
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

  • Patient must be ≥18 years at the time of signing the informed consent
  • ECOG performance status of 0-2
  • Histologically confirmed diagnosis (by 2008 World Health Organization [WHO] classification) of follicular lymphoma (grade 1, 2 or 3a)
  • At least one (but not more than 3) prior regimens with an anti-CD20 antibody (alone or in combination with chemotherapy), with documented relapsed, refractory disease (must not be anti-CD20 antibody-refractory) or PD
  • Presence of at least one bi-dimensionally measurable lesion by CT or MRI: longest diameter (LDi) >1.5 cm for a nodal lesion; LDi >1.0 cm for an extranodal lesion within 28 days prior to start of treatment
  • Normal organ and bone marrow function defined as:
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  • 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 [<3.0 mg/dL]);
  • 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 within the upper limit of normal range
  • Bone marrow involvement by lymphoma <25%
  • Life expectancy >3 months
  • Negative hepatitis B, hepatitis C and human immunodeficiency virus (HIV) screening tests
  • Patients must agree to use effective contraception for 12 months following last study drug administration

Who cannot join

  • Previous haematopoietic stem cell transplantation (autologous and allogenic)
  • Evidence of histological transformation from FL to DLBCL at time of screening.
  • Previous total body irradiation
  • Chemotherapy, immunotherapy or investigational therapy within 28 days before the start of study drug administration (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) or failure to recover from AEs associated with prior treatment
  • Previous treatment with radioimmunotherapy
  • Patients who are receiving any other investigational medicinal products
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  • Known or suspected central nervous system (CNS) involvement of lymphoma
  • 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 or localised 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 CR
  • Pregnant or lactating women
  • Exposure to another CD37 targeting drug
  • A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in RTX, lilotomab or Betalutin
  • Receipt of live, attenuated vaccine within 30 days prior to enrolment
  • Evidence of severe or uncontrolled systemic diseases (e.g. ongoing infection, respiratory, cardiac, hepatic or psychiatric conditions) which in the Investigator's opinion would compromise the protocol objectives

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Czechia1 site

  • Klinika Hematoonkologie

    Ostrava, Porubá, 807-52

Other trials in Czechia

Norway1 site

  • Oslo University Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)

This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab.

Being tested
10 MBq/kg Betalutin, 15 MBq/kg Betalutin
Keywords
Radioimmunotherapy, Lu-177, Betalutin, Phase 1b, Combination, Rituximab
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

    10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

  • 15 MBq/kg BetalutinDrug

    15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

Study groups in NCT03806179
Study groupRoleWhat they receive
10 MBq/kg Betalutin with rituximab treatmentExperimental10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years
Receives: Drug: 10 MBq/kg Betalutin
15 MBq/kg Betalutin with rituximab treatmentExperimental15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years
Receives: Drug: 15 MBq/kg Betalutin

What is being measured

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

  1. Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03)

    Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin

    Measured: 12 weeks

Secondary outcomes (1)

  1. Preliminary Anti-tumour Activity

    Best overall response of combination treatment using tumour responses based on CT and PET/CT imaging (classified as as complete response, partial response, no response/stable disease or progressive disease as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification")

    Measured: 25 months

Timeline

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

  1. First posted16 Jan 2019
  2. Study start4 Oct 2018
  3. Primary completion8 Aug 2022
  4. Study completion8 Aug 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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806179
Sponsor's protocol ID
LYMRIT -37-07(Archer-1)
Other IDs
2017-004506-18, 2017
Acronym
LYMRIT-37-07
Status last verified
Dec 2023
First submitted
14 Jan 2019
Last updated
22 Dec 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Repetto-Llamazares AHV, Malenge MM, O'Shea A, Eiriksdottir B, Stokke T, Larsen RH, Dahle J. Combination of 177 Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin's lymphoma. Eur J Haematol. 2018 Oct;101(4):522-531. doi: 10.1111/ejh.13139. Epub 2018 Aug 31.

    PubMed 29993152

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 10 MBq/kg Betalutin and 15 MBq/kg Betalutin in people with Non Hodgkin Lymphoma and Follicular Lymphoma, run by Nordic Nanovector at 2 sites in 2 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 16 inclusion and 18 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Norway. 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 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.

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 22 Dec 2023). 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?

Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03) (time frame: 12 weeks). 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 NCT03806179, which also lists 2 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 22 Dec 2023.

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