World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 January 2019
Main ID:  EUCTR2017-004506-18-NO
Date of registration: 02/01/2018
Prospective Registration: Yes
Primary sponsor: Nordic Nanovector ASA
Public title: Treatment of lymphoma with targeted internal radiation therapy (Betalutin) in combination with rituximab
Scientific title: A phase 2 open-label study of Betalutin in combination with rituximab in patients with relapsed/refractory follicular lymphoma (Archer-1)
Date of first enrolment: 13/06/2018
Target sample size: 25
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004506-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Norway
Contacts
Name: Clinical Research Manager   
Address:  Kjelsåsveien 168B N-0884 Oslo Norway
Telephone: +4793066092
Email: aostengen@nordicnanovector.com
Affiliation:  Nordic Nanovector ASA
Name: Clinical Research Manager   
Address:  Kjelsåsveien 168B N-0884 Oslo Norway
Telephone: +4793066092
Email: aostengen@nordicnanovector.com
Affiliation:  Nordic Nanovector ASA
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patient must be = 18 years at the time of signing the informed consent
2. A pre-study ECOG performance status of 0-2
3. Histologically confirmed diagnosis (by 2008 WHO classification) of indolent non-Hodgkin B-cell follicular lymphoma (grade 1, 2 or 3a)
4. 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
5. Presence of at least one bi-dimensionally measurable lesion by CT: 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
6. Normal organ and bone marrow function defined as:
a. Absolute neutrophil count =1.5 x 10*9/L;
b. Platelet count =150 x 10*9/L;
c. Haemoglobin =9 g/dL;
d. Total bilirubin =1.5 x upper limit of normal (ULN) (except patients with documented Gilbert’s syndrome [< 3.0 mg/dL]);
e. Liver enzymes: 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);
f. Adequate renal function as demonstrated by a serum creatinine <1.5 x ULN;
7. Bone marrow involvement by lymphoma <25%
8. Life expectancy >3 months
9. Negative hepatitis B, hepatitis C and HIV screening tests
10. Negative ADA test at screening for lilotomab/Betalutin
11. Women of childbearing potential (see Protocol Appendix 3) must:
a. have a negative serum pregnancy test at screening and before Betalutin injection
b. understand that the study medication is expected to have teratogenic risk
c. 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, from 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhea
12. Male patients must agree to use condoms (See Protocol Appendix 3) during intercourse throughout study drug therapy and the following 12 months
13. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination
14. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion criteria:
1. Previous haematopoietic stem cell transplantation (autologous and allogenic)
2. Evidence of histological transformation from FL to DLBCL at time of screening.
3. Previous total body irradiation
4. Chemotherapy, immunotherapy, radioimmunotherapy, or investigational therapy within 28 days before the start of study drug treatment (corticosteroid treatment at doses of = 20 mg/day, topical or inhaled corticosteroids, G-CSF or GM CSF are permitted up to 2 weeks prior to start of study treatment) or failure to recover from adverse events (AEs) associated with prior treatment
5. Patients who are receiving any other investigational medicinal products
6. Known or suspected central nervous system (CNS) involvement of lymphoma
7. History of a previous treated cancer except for the following:
a. adequately treated local basal cell or squamous cell carcinoma of the skin
b. cervical carcinoma in situ
c. superficial bladder cancer
d. localised prostate cancer undergoing surveillance or surgery
e. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
f. other adequately treated Stage 1 or 2 cancer currently in CR
8. Pregnant or lactating women (See Protocol Appendix 3)
9. Exposure to another CD37 targeting drug
10. A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin
11. Receipt of live, attenuated vaccine within 30 days prior to enrolment
12. Evidence of severe or uncontrolled systemic diseases:
a. Uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment
b. Pulmonary conditions e.g. unstable or uncompensated respiratory disease
c. Hepatic, renal, neurological, or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives
d. Psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study
e. History of erythema multiforme, toxic epidermal necrolysis, or Stevens Johnson syndrome
f. Cardiac conditions, including:
i. history of acute coronary syndromes (including unstable angina)
ii. class II, III, or IV heart failure as defined by the NYHA functional classification system
iii. known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cancer [C04]
Follicular lymphoma
MedDRA version: 20.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intervention(s)

Product Name: Betalutin
Product Code: Lutetium (177Lu)-lilotomab satetraxetan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lutetium (177Lu)-lilotomab satetraxetan
CAS Number: 1453362-90-7
Current Sponsor code: 177Lu-DOTA-HH1
Other descriptive name: 177LU-TETRAXETAN-HH1
Concentration unit: MBq/ml megabecquerel(s)/millilitre
Concentration type: range
Concentration number: 770-5200

Product Name: Lilotomab
Product Code: HH1
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Lilotomab
CAS Number: 1453362-55-4
Current Sponsor code: HH1
Other descriptive name: TETULOMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: MabThera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Primary Outcome(s)
Main Objective: Primary
• To evaluate preliminary anti-tumour activity of combination treatment based on Investigator assessment of tumour response rates

Primary end point(s): • Responses [(overall response rate (ORR), CR, PR, stable disease (SD), progressive disease (PD)] as per Cheson 2014
Secondary Objective: Secondary
• To evaluate the duration of tumour control in patients receiving Betalutin in combination with RTX
• To characterize the safety and tolerability of Betalutin combined with RTX
• To investigate the immunogenicity of Betalutin in combination with RTX
Timepoint(s) of evaluation of this end point: From baseline and up to 5 years post injection
Secondary Outcome(s)
Secondary end point(s): • Duration of response (DoR)
• Progression free survival (PFS)
• Time to progression (TTP)
• Overall survival (OS)
• Frequency and severity of adverse events (AEs) and laboratory abnormalities graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
• Monitoring of the anti-drug antibody (ADA) response towards lilotomab, Betalutin and/or RTX
Timepoint(s) of evaluation of this end point: From baseline and up to 5 years post injection
Secondary ID(s)
LYMRIT-37-07
Source(s) of Monetary Support
Kreftforeningen
Skattefunn
Innovation Norway
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history