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

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Recruitment Status : Withdrawn (Study is no longer relevant)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

Tracking Information
First Submitted Date  ICMJE December 22, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE December 19, 2017
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
Dosimetry [ Time Frame: 3 weeks ]
Estimation of individual tumour/organ uptake and retention of radioactivity.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • The number of participants with adverse events as assessed by NCTCAE. [ Time Frame: 12 weeks ]
    Adverse events by treatment group.
  • Efficacy (Best overall response rate) [ Time Frame: 3 months - 1 year ]
    Best overall response rate by treatment group as measured by Cheson Criteria.
  • Lilotomab pharmacokinetics [ Time Frame: 3 weeks ]
    Estimation using decay correction measurements
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • The number of participants with adverse events as assessed by NCTCAE. [ Time Frame: 12 weeks ]
    Adverse events by treatment group.
  • Efficacy (Best overall response rate) [ Time Frame: 3 months - 1 year ]
    Best overall response rate by treatment group as measured by Chesson Criteria.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin Lymphoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1: Betalutin with lilotomab dose 1
    Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing
    Intervention: Drug: Betalutin with lilotomab dose 1
  • Experimental: Arm 2: Betalutin with lilotomab dose 2
    Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
    Intervention: Drug: Betalutin with lilotomab dose 2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
12
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657447
Other Study ID Numbers  ICMJE EudraCT: 2013-003908-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nordic Nanovector
Study Sponsor  ICMJE Nordic Nanovector
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Buck, Prof. MD Wuerzburg University Hospital
PRS Account Nordic Nanovector
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP