Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)
The aim of the trial is to evaluate the molecular characteristics and MDD/MRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET/CT in assessment of the completeness of remission. The following primary study questions are going to be analyzed: - the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates. - the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates. - the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by "second-line" block VICI in order to improve results Secondary study questions will address - additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates - kinetics of immune reconstitution after treatment
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 16, 2027 |
Est. primary completion date | May 16, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | Inclusion Criteria: - Age at diagnosis 0 to 18 years. - The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL - Informed consent of the patient parents (guardians) to be treated Exclusion Criteria: - previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency - hypersensitivity to rituximab or to ingredients of other IMPs. - no informed consent of the patient parents (guardians) to be treated |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology | Moscow | RF |
Lead Sponsor | Collaborator |
---|---|
Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival | Event-free survival The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies. | 3 years after the start of therapy | |
Primary | Event-free survival | Event-free survival The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies. | 7 years after the start of therapy | |
Secondary | assessment of MDD and MRD indicators, p53 and 11qLOH status in patients on the B-NHL-M-2021 protocol | 3 years after the start of therapy | ||
Secondary | assessment of MDD and MRD indicators, p53 and 11qLOH status in patients on the B-NHL-M-2021 protocol | 7 years after the start of therapy | ||
Secondary | assessment of PET-CT results - initial and control points (early PET response).after the 2nd block | measurement of tumor volume at diagnosis and measurement of tumor volume reduction after therapy in percent after the 2nd block - CT with CL of the involved areas, PET-CT examination on the 14th day (maximum on the 17th day) after the last injection of CT, IPT, MRD in the bone marrow | after the 2nd block - CT with CL of the involved areas, PET-CT examination on the 14th day (maximum on the 17th day) after the last injection of CT, IPT, MRD in the bone marrow - after 4th block - CT with the CL of the involved areas | |
Secondary | assessment of PET-CT results - initial and control points (early PET response) after 4th block | measurement of tumor volume at diagnosis and measurement of tumor volume reduction after therapy in percent after 4th block - CT with the CL of the involved areas , PET-CT examination on the 14th day (maximum on the 17th day) after the last administration of CT, MRD in the bone marrow if present after the 2nd block After the 6th block - CT with CL of the involved areas | PET-CT examination on the 14th day (maximum on the 17th day) after the last administration of CT, MRD in the bone marrow if present after the 2nd block | |
Secondary | Relapse-free survival (RFS) | RFS is defined as time from start of treatment up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse. | 3 years after the start of therapy | |
Secondary | Relapse-free survival (RFS) | RFS is defined as time from start of treatment up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse. | 7 years after the start of therapy | |
Secondary | Response rate (RR) [ and after second course and after two injections of rituximab]. Complete response, partial remission, stable disease or progressive disease | 3 years after the start of therapy | ||
Secondary | Response rate (RR) [ and after second course and after two injections of rituximab]. Complete response, partial remission, stable disease or progressive disease | 7 years after the start of therapy | ||
Secondary | Rate of patients achieving normal immunoglobulin level | 12 months after start of treatment | ||
Secondary | Rate of patients with normal lymphocyte subpopulations in the peripheral blood 12 months after start of treatment | 12 months after start of treatment | ||
Secondary | Interval to normal lymphocyte subpopulations in the peripheral blood. | 7 years after the start of therapy | ||
Secondary | Rate of patients with sufficient titers after vaccination one year after start of treatment | 1 year after start of treatment | ||
Secondary | Immune reconstitution rate (only in R1/R2 patients) | 1 year after start of treatment | ||
Secondary | Time interval from start of treatment to normal CD19 positive B-cells in the peripheral blood. | 1 year after start of treatment |
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