Peripheral T-cell Lymphoma
Conditions
Keywords
PTCL, Peripheral T-Cell Lymphoma, brentuximab vedotin
Brief summary
There is no data comparing the effectiveness of the 4 most relevant first-line therapy programs for peripheral T-cell lymphomas (CHOEP, CHOP, CHEP-BV, CHP-BV) in a single study. For the first time, the effectiveness and toxicity of various first-line PTCL therapy programs in patients with T-cell lymphoma will be analyzed in the conditions of a single medical center of the N.N.Petrov National Research Medical Center of Oncology and optimal therapeutic tactics will be determined, taking into account significant prognostic factors based on effectiveness and toxicity a specific chemotherapy regimen.
Detailed description
A non-randomized retrospective cohort study with prospective inclusion is planned. Patients with a confirmed diagnosis of PTCL (who meet the inclusion criteria) who were treated at the same center of the NN Petrov National Medical Cancer Research Center from 2013 to 2024, depending on the first-line therapy regimen, will be included in the retrospective part of the study and divided into 2 groups: Group 1: CHOEP regimen Group 2: CHOP regimen The prospective part of this study is planned to include patients (who meet the inclusion criteria) who are hospitalized at the NN Petrov National Medical Cancer Research Center for treatment from January 2024 to January 2027. Patients will be divided into 2 groups depending on the chemotherapy regimen: Group 3: chemoimmunotherapy according to the CHP-BV regimen Group 4: chemoimmunotherapy according to the CHEP-BV regimen Based on the data from the medical documentation of patients, the main statistical indicators of the effectiveness of first-line treatment regimens will be calculated using objective methods for assessing the antitumor effect (PET CT, CT), the toxicity of each of the regimens will be assessed, as well as possible prognostic factors for all patient groups.
Interventions
DRUGDoxorubicin
doxorubicin 50 mg/m2, day 1
DRUGVincristine
vincristine 1.4 mg/m2, (maximum dose 2 mg) day 1
DRUGEtoposide
Etoposide 100 mg/m2, 1-3 days
DRUGcyclophosphamide
cyclophosphamide 750 mg/m2, day 1
DRUGPrednisone
prednisone 100 mg, 1-5 days
brentuximab vedotin 1.8 mg / kg, day 1
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly diagnosed mature T-cell lymphomas * absence of acute infectious diseases during treatment diseases, chronic diseases in the stage of decompensation * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion criteria
* the presence of a history of other malignant neoplasms during the 5-year period before the start of first-line therapy, In addition to in situ neoplasms treated according to appropriate treatment protocols, * there are acute infectious diseases and chronic diseases in the decompensation stage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate | Up to 8 months | \- Primary endpoints: the complete response rate - The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 8 months | Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. |
| Progression-free Survival | up to 1 year | The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first. |
| Overall Survival (OS) | up to 1 year | The time from randomization to death due to any cause. |
Outcome results
None listed