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

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ClinicalTrials.gov Identifier: NCT03806179
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Nordic Nanovector

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.

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Follicular Lymphoma Relapsed Follicular Lymphoma Drug: Betalutin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Betalutin with rituximab treatment
Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7
Drug: Betalutin
Betalutin 10, 15 MBq/kg; lilotomab 40mg, rituximab 375 mg/m2




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03806179


Contacts
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Contact: Clinical Trials 00 47 22183301 clinicaltrials@nordicnanovector.com

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, N-0310
Sponsors and Collaborators
Nordic Nanovector
ICON Clinical Research
Investigators
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Principal Investigator: Arne Kolstad, MD Oslo University Hospital

Publications:
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Responsible Party: Nordic Nanovector
ClinicalTrials.gov Identifier: NCT03806179     History of Changes
Other Study ID Numbers: EudraCT: 2017-004506-18
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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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:
Radioimmunotherapy
Lu-177
Betalutin
Phase 1b
Combination
Rituximab

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents