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Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL (LYMRIT-37-07)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03806179
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : September 10, 2019
ICON Clinical Research
Information provided by (Responsible Party):
Nordic Nanovector

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Safety and Tolerability: frequency and severity of adverse events (CTCAE v4.03) [ Time Frame: 12 weeks ]
Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03806179 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
Preliminary Anti-tumour Activity [ Time Frame: 3 months - 5 years ]
Preliminary anti-tumour activity of combination treatment based on tumour response rates per Cheson 2014
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL
Official Title  ICMJE A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)
Brief 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 in combination with rituximab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Hodgkin Lymphoma
  • Follicular Lymphoma
  • Relapsed Follicular Lymphoma
Intervention  ICMJE Drug: Betalutin
Betalutin 10, 15 MBq/kg; lilotomab 40mg, rituximab 375 mg/m2
Study Arms  ICMJE Experimental: Betalutin with rituximab treatment
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
Intervention: Drug: Betalutin
Publications * Repetto-Llamazares AHV, Malenge MM, O'Shea A, Eiríksdóttir 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1. Absolute neutrophil count ≥1.5 x 109/L;
    2. Platelet count ≥150 x 109/L;
    3. Haemoglobin ≥9 g/dL;
    4. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome [<3.0 mg/dL]);
    5. 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);
    6. 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

Exclusion criteria:

  • 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
  • Known or suspected central nervous system (CNS) involvement of lymphoma
  • History of a previous treated cancer except for the following:

    1. adequately treated local basal cell or squamous cell carcinoma of the skin
    2. cervical carcinoma in situ
    3. superficial bladder cancer or localised prostate cancer undergoing surveillance or surgery
    4. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
    5. 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
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: Clinical Trials 00 47 22183301
Listed Location Countries  ICMJE Czechia,   Norway,   Poland,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03806179
Other Study ID Numbers  ICMJE LYMRIT -37-07(Archer-1)
2017-004506-18 ( Other Identifier: EudraCT )
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 Not Provided
Responsible Party Nordic Nanovector
Study Sponsor  ICMJE Nordic Nanovector
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Principal Investigator: Arne Kolstad, MD.PhD Oslo University Hospital
PRS Account Nordic Nanovector
Verification Date September 2019

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