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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. Read our disclaimer for details. Identifier: NCT03806179
Recruitment Status : Active, not recruiting
First Posted : January 16, 2019
Last Update Posted : March 2, 2022
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)
Actual Enrollment : 7 participants
Allocation: N/A
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 : October 2022
Estimated Study Completion Date : December 2022

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, then every 3 months for 2 years
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: 25 months ]
    Preliminary anti-tumour activity of combination treatment based on tumour response rates per Cheson 2014

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:

  • 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 identifier (NCT number): NCT03806179

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Klinika Hematoonkologie
Ostrava-, Porubá, Czechia, 807-52
Oslo University Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Nordic Nanovector
ICON Clinical Research
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Principal Investigator: Alexander Fosså, MD.PhD Oslo University Hospital
Additional Information:
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Responsible Party: Nordic Nanovector Identifier: NCT03806179    
Other Study ID Numbers: LYMRIT -37-07(Archer-1)
2017-004506-18 ( Other Identifier: EudraCT )
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 1b
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin