Non Hodgkin Lymphoma Clinical Trial

Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)

Summary

This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerable dose of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and toxicity, pharmacokinetics, biodistribution and efficacy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female aged ≥18 years.
Histologically confirmed DLBCL (WHO classification).
Received at least one prior line of therapy including immuno-chemotherapy.
In first or subsequent relapse, or refractory to the last treatment (defined as less than a complete metabolic response to the last treatment, or disease progression within 6 months from the last treatment).
Not suitable for, or declined/unwilling to undergo intensive therapy, including high dose chemotherapy and autologous stem cell transplantation (ASCT).
Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (at least one objectively bi-dimensionally measurable (nodal) lesion (>1.5 cm in its largest dimension by CT scan).
Negative human anti-mouse antibody (HAMA) test.
Life expectancy of at least 3 months.
Bone marrow tumour infiltration <25% tumour cells.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

Normal organ and bone marrow function defined as:

Absolute neutrophil count ≥1.5 x 109/L
Platelet count ≥150 x 109/L;
Haemoglobin ≥9 g/dL
Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome)
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)
Adequate renal function as demonstrated by a serum creatinine ≤1.5 mg/dL or a creatinine clearance >60 mL/min
Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ≤1.3 ULN range acceptable)

Women of childbearing potential must:

Understand that the study medication may have teratogenic risk
Have a negative serum pregnancy test at screening and before Betalutin injection

Commit to continued abstinence from heterosexual intercourse (excluding periodic abstinence or the withdrawal method) or begin two acceptable methods of birth control with a Pearl-Index ≤ 1%. 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 amenorrhoea. Apart from abstinence, acceptable methods of birth control are:

Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner
Male patients must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
Ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
A negative Hepatitis B test (HBsAg and anti-HBc) and negative HIV test during screening

Exclusion Criteria:

Prior hematopoietic allogenic stem cell transplantation.
Prior autologous stem cell transplantation.
Previous total body irradiation.
Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other investigational agent), excluding corticosteroids within 4 weeks prior to start of study treatment (i.e. rituximab) (G-CSF or GM-CSF are permitted up to 2 weeks prior to start of study treatment.)
Patients who are receiving any other investigational agents.
Patients with known or suspected central nervous system involvement of lymphoma.

History of a previous treated cancer except for the following:

Adequately treated local basal cell or squamous cell carcinoma of the skin
Cervical carcinoma in situ
Superficial bladder cancer
Localized prostate cancer undergoing surveillance or surgery
Localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
Other adequately treated Stage 1 or 2 cancer currently in complete remission
Pregnant or breastfeeding women.
Exposure to another CD37 targeting drug.
Allergy to X ray contrast agents.
A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, lilotomab or Betalutin.
Has received a live attenuated vaccine within 30 days prior to enrolling in the study.

Evidence of severe or uncontrolled systemic diseases:

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
Pulmonary conditions e.g. unstable or uncompensated respiratory disease
Hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives
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
History of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome

Cardiac conditions, including:

history of acute coronary syndromes (including unstable angina)
class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT02658968

Recruitment Status:

Completed

Sponsor:

Nordic Nanovector

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There are 10 Locations for this study

See Locations Near You

University of California, San Diego (UCSD) - Moores Cancer Center
San Diego California, 92093, United States
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances
San Francisco California, 94117, United States
Sylvester Comprehensive Cancer Centre
Miami Florida, 33146, United States
Klinikum rechts der Isar der TU München
Munich , 81675, Germany
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona , 37134, Italy
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT02658968

Recruitment Status:

Completed

Sponsor:


Nordic Nanovector

How clear is this clinincal trial information?

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