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Non-Hodgkin LymphomaPhase 1NCT02657447

Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)

A Phase 1 study testing Betalutin with lilotomab dose 1 and Betalutin with lilotomab dose 2 in people with Non-Hodgkin Lymphoma, run by Nordic Nanovector at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
Betalutin with lilotomab dose 1 and Betalutin with lilotomab dose 2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
19 Dec 2017to Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA), Marginal zone lymphoma (exclusion of MZL if large lymphocytes > 50%), Small lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no blastoid MCL).
  • Requiring initiation of treatment for the NHL.
  • Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
  • Exhausted and/or ineligible for all standard treatment options.
  • Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in progression after successful stem cell collection before before high-dose therapy and autologous stem cell transplantation may be considered for enrolment.
  • Age ≥ 18 years..
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  • A pre-study ECOG performance status of 0-2. In selected patients an ECOG score of 3 can be acceptable if it is clearly lymphoma-associated at the discretion of the investigator.
  • Life expectancy should be ≥ 3 months.
  • 9. < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).
  • All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan). Patients without such a target lesion can be accepted on an individual basis if histological organ involvement can be evaluated for response e.g. involvement of the skin or the gastrointestinal tract.
  • Women of childbearing potential must:
  • have a negative serum pregnancy test at screening and before Betalutin injection
  • understand that the study medication is expected to have teratogenic risk
  • agree to use, and be able to comply with, highly effective method of birth control with a Pearl-Index ≤ 1%. Contraception is required without interruption, 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.
  • Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
  • Patients previously treated with native rituximab are eligible.
  • The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
  • The patient has been fully informed about the study and has signed the informed consent form.
  • Negative HAMA test.
  • CD37 positive, re-biopsy or test on existing tumour material if not known

Who cannot join

  • Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
  • Laboratory values during screening :
  • 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
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  • GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.
  • Known or suspected CNS involvement of lymphoma
  • Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
  • Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
  • Earlier treatment with radioimmunotherapy.
  • Exposure to another CD37 targeting drug.
  • Concurrent participation in another therapeutic treatment trial.
  • Previous hematopoietic stem cell transplantation (autologous and allogenic).
  • Pregnant or lactating women.
  • Transformed or potentially transformed NHL from indolent to aggressive
  • 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
  • Malignant disease, other than that being treated in this study. Exceptions include: malignancies that were treated curatively and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancers; completely resected carcinoma in situ of any type.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma

This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.

Being tested
Betalutin with lilotomab dose 1, Betalutin with lilotomab dose 2
Keywords
Radioimmunotherapy, Lu-177, Phase I study, Betalutin, ARC, Antibody Radionuclide Conjugate, HH1, Rituximab, 177Lu-DOTA-HH1, Lymphoma, Lymphoma Non-Hodgkin, Immune System Diseases, Follicular Lymphoma, Marginal Zone Lymphoma, Lymphoplasmacytoid, Lymphatic Diseases, Lymphoproliferative Disorders, Neoplasms, Neoplasms by Histological Type, Small Lymphocytic Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, AIDS-Related Complex, Lymphoma, Immune System Diseases, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphatic Diseases, Lymphoproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Betalutin with lilotomab dose 1Drug

    Also called Betalutin, Lymrit 37-02, lutetium (177Lu) lilotomab satetraxetan, HH1

    15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1

  • Betalutin with lilotomab dose 2Drug

    Also called Betalutin, Lymrit 37-02, lutetium (177Lu) lilotomab satetraxetan, HH1

    15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2

Study groups in NCT02657447
Study groupRoleWhat they receive
Arm 1: Betalutin with lilotomab dose 1ExperimentalBetalutin 15 MBq/kg b.w. with lilotomab pre-dosing
Receives: Drug: Betalutin with lilotomab dose 1
Arm 2: Betalutin with lilotomab dose 2ExperimentalBetalutin 15MBq/kg b.w. with lilotomab pre-dosing
Receives: Drug: Betalutin with lilotomab dose 2

What is being measured

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

  1. Dosimetry

    Estimation of individual tumour/organ uptake and retention of radioactivity.

    Measured: 3 weeks

Secondary outcomes (3)

  1. The number of participants with adverse events as assessed by NCTCAE.

    Adverse events by treatment group.

    Measured: 12 weeks

  2. Efficacy (Best overall response rate)

    Best overall response rate by treatment group as measured by Cheson Criteria.

    Measured: 3 months - 1 year

  3. Lilotomab pharmacokinetics

    Estimation using decay correction measurements

    Measured: 3 weeks

Timeline

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

  1. First posted15 Jan 2016 (estimated)
  2. Study start19 Dec 2017
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2020 (estimated)

Why it stopped: Study is no longer relevant

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657447
Sponsor's protocol ID
EudraCT: 2013-003908-39
Status last verified
Jan 2019
First submitted
22 Dec 2015
Last updated
10 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23267131

  • 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.

    PubMed 23256748

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Betalutin with lilotomab dose 1 and Betalutin with lilotomab dose 2 in people with Non-Hodgkin Lymphoma, run by Nordic Nanovector at 1 site in Germany.

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 20 inclusion and 20 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: withdrawn, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Dosimetry (time frame: 3 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 NCT02657447, 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 10 Jan 2019.

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