Description:
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.
Title
- Brief Title: Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL
- Official Title: A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)
Clinical Trial IDs
- ORG STUDY ID:
LYMRIT -37-07(Archer-1)
- SECONDARY ID:
2017-004506-18
- NCT ID:
NCT03806179
Conditions
- Non Hodgkin Lymphoma
- Follicular Lymphoma
- Relapsed Follicular Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Betalutin | | Betalutin with rituximab treatment |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Betalutin with rituximab treatment | Experimental | 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 | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and Tolerability: frequency and severity of adverse events (CTCAE v4.03) |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | 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
Measure: | Preliminary Anti-tumour Activity |
Time Frame: | 3 months - 5 years |
Safety Issue: | |
Description: | Preliminary anti-tumour activity of combination treatment based on tumour response rates per Cheson 2014 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Nordic Nanovector |
Trial Keywords
- Radioimmunotherapy
- Lu-177
- Betalutin
- Phase 1b
- Combination
- Rituximab
Last Updated
January 3, 2020