Status and phase
Conditions
Treatments
About
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 tolerated dose (MTD) 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 tolerability, pharmacokinetics, biodistribution and efficacy.
Enrollment
Sex
Ages
Volunteers
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:
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:
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informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.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:
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:
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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