BCD-283-1 "A double-blind clinical trial with randomized assignment of the pharmacokinetics, safety, and immunogenicity of BCD-283 in patients with relapsed/refractory classical Hodgkin's lymphoma".
The BCD-283-1 clinical trial will study the equivalence of pharmacokinetics and similarity of the safety and immunogenicity profiles of BCD-283 and the reference product when administered intravenously to patients with relapsed/refractory classical Hodgkin's lymphoma who:
Have reached the age of 18 years at the time of signing the informed consent form;
Have a body weight under 100 kg at the time of signing the informed consent form;
Have a documentary evidence of a histologically verified diagnosis of relapsed/refractory classical Hodgkin's lymphoma:
Either after auto-HSCT1 that was performed not less than 12 weeks prior to the first planned brentuximab vedotin infusion in this study;
Or after at least two lines of prior therapy when auto-HSCT or combination chemotherapy is not considered a treatment option;
Have a CD30+ lymphoma immunophenotype confirmed immunohistochemically by central pathomorphologic review of the last available tumor tissue specimen after refractoriness/relapse has been established;
Have a positive metabolic response on positron emission tomography (PET) scan at screening, corresponding to a Deauville score of 4 or 52;
Have a measurable tumor lesion on computed tomography;
Have an ECOG3 performance score of 0–1.
The clinical Study Protocol provides for a biopsy of the accessible tumor site followed by a pathomorphological assessment of the lymphoma immunophenotype or a review of archived biomaterial (i.e., a tumor sample taken prior to the signing of the clinical trial participant information sheet with the informed consent form) as part of the clinical trial.
This clinical trial has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, the exclusion criteria are:
A history of myelodysplastic syndrome, acute myeloid leukemia, or malignant neoplasm (MN), except for the following:
Carcinoma in situ or non-melanoma skin cancer,
MN diagnosed and radically treated more than 3 years prior to signing the clinical trial participant information sheet with informed consent form, with no evidence of progression or relapse at the time of screening4,
Prior allogeneic hematopoietic stem cell transplantation (alloHSCT) or a history of CAR-T cellular therapy,
Prior treatment with the following drug products:
Brentuximab vedotin less than 6 months prior to randomization5,
Brentuximab vedotin more than 6 months prior to randomization, provided that therapy was interrupted due to disease progression (in the absence of a previous partial or complete response to brentuximab vedotin therapy) or due to unacceptable toxicity,
Control point inhibitor group drugs less than 3 months prior to randomization,
Control point inhibitor group drugs more than 3 months prior to randomization, if partial response, stabilization, or indeterminate response persists at last follow-up,
Prior chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to the first infusion of brentuximab vedotin in this study,
Subjects with life-threatening acutely developing complications of the underlying disease (including massive, requiring intervention, pleural, pericardial or peritoneal effusion, superior vena cava compression syndrome, tumor lysis syndrome, or other) at the time of signing the informed consent form,
A diagnosis of grade 2 or higher peripheral neuropathy according to the CTCAE classification6 at the time of signing the informed consent form,
Evidence of active lesions of brain matter and/or meninges associated with Hodgkin's lymphoma, including progressive multifocal leukoencephalopathy (PML), or a history of PML. Eligible to participate are treated patients with a history of lesions of brain matter and/or meninges (other than a history of PML) who have no evidence of disease activity at screening,
HIV infection, active hepatitis C or hepatitis B.
The CT participant may be provided with transportation services for the relevant trips, as well as accommodation services for undergoing visits within the BCD-283-1 clinical trial, if required, as agreed upon with the Clinical Investigator, and upon the CT participant’s consent. Reimbursement of transportation/accommodation costs associated with participation in the BCD-283-1 clinical trial is provided by JSC BIOCAD.
The BCD-283-1 clinical trial is being conducted in study centers in different cities of the Russian Federation and the Republic of Belarus, including Moscow, St. Petersburg, Novosibirsk, Syktyvkar, Sochi, Kaluga, Krasnoyarsk, Tver, Kirov, Kazan, Omsk, Ufa, Saratov, Minsk, Vitebsk.
To ask questions about potential participation in a clinical trial, including contact details of study centers, please use a special form at ct.biocad.ru.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and/or their attending physician.
Clinical Study Authorization No. 407 dated September 09, 2025 of the Ministry of Health of the Russian Federation and the list of authorized study centers are published in the State Register of Medicines.
Clinical Study Authorization No. 129/1043/2025 dated September 12, 2025 of the Ministry of Health of the Republic of Belarus and the list of authorized study centers on the territory of the Republic of Belarus are published inthe State Register of Clinical Trials of the Republic of Belarus.
Auto-HSCT is the autologous hematopoietic stem cell transplantation.
Deauville is a visual evaluation scale (Deauville or 5-point scale) used to evaluate the intensity of fluorodeoxyglucose absorption in a tumor in comparison to its absorption in the liver and mediastinum.
ECOG scale is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical study according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.
Randomization is a random assignment of clinical trial subjects to one of the treatment groups.
CTCAE are the Common Toxicity Criteria for Adverse Events.