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

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. Identifier: NCT02657447
Recruitment Status : Withdrawn (Study is no longer relevant)
First Posted : January 15, 2016
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Nordic Nanovector

Brief 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. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Drug: Betalutin with lilotomab dose 1 Drug: Betalutin with lilotomab dose 2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Arm 1: Betalutin with lilotomab dose 1
Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 1
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1
Other Names:
  • Betalutin
  • Lymrit 37-02
  • lutetium (177Lu) lilotomab satetraxetan
  • HH1
  • 177Lu-DOTA-HH1

Experimental: Arm 2: Betalutin with lilotomab dose 2
Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 2
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2
Other Names:
  • Betalutin
  • Lymrit 37-02
  • lutetium (177Lu) lilotomab satetraxetan
  • HH1
  • 177Lu-DOTA-HH1

Primary Outcome Measures :
  1. Dosimetry [ Time Frame: 3 weeks ]
    Estimation of individual tumour/organ uptake and retention of radioactivity.

Secondary Outcome Measures :
  1. The number of participants with adverse events as assessed by NCTCAE. [ Time Frame: 12 weeks ]
    Adverse events by treatment group.

  2. Efficacy (Best overall response rate) [ Time Frame: 3 months - 1 year ]
    Best overall response rate by treatment group as measured by Cheson Criteria.

  3. Lilotomab pharmacokinetics [ Time Frame: 3 weeks ]
    Estimation using decay correction measurements

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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).
  2. Requiring initiation of treatment for the NHL.
  3. Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
  4. Exhausted and/or ineligible for all standard treatment options.
  5. 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.
  6. Age ≥ 18 years..
  7. 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.
  8. Life expectancy should be ≥ 3 months.
  9. 9. < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).
  10. 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.
  11. 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.
  12. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
  13. Patients previously treated with native rituximab are eligible.
  14. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
  15. The patient has been fully informed about the study and has signed the informed consent form.
  16. Negative HAMA test.
  17. CD37 positive, re-biopsy or test on existing tumour material if not known

Exclusion Criteria:

  1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
  2. 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
    • GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.
  3. Known or suspected CNS involvement of lymphoma
  4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
  5. Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
  6. Earlier treatment with radioimmunotherapy.
  7. Exposure to another CD37 targeting drug.
  8. Concurrent participation in another therapeutic treatment trial.
  9. Previous hematopoietic stem cell transplantation (autologous and allogenic).
  10. Pregnant or lactating women.
  11. Transformed or potentially transformed NHL from indolent to aggressive
  12. Receipt of live, attenuated vaccine within 30 days prior to enrolment
  13. Test positive for hepatitis B (HBsAg and anti-HBc)
  14. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
  15. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02657447

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Universitätsklinikum Würzburg
Würzburg, Germany
Sponsors and Collaborators
Nordic Nanovector
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Principal Investigator: Andreas Buck, Prof. MD Wuerzburg University Hospital
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Responsible Party: Nordic Nanovector Identifier: NCT02657447    
Other Study ID Numbers: EudraCT: 2013-003908-39
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordic Nanovector:
Phase I study
Antibody Radionuclide Conjugate
Lymphoma Non-Hodgkin
Immune System Diseases
Follicular Lymphoma
Marginal Zone Lymphoma
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histological Type
Small Lymphocytic Lymphoma
Classical Mantle Cell Lymphoma
Lutetium (177Lu) lilotomab satetraxetan
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action