Trial Title:
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021
NCT ID:
NCT05518383
Condition:
Non-hodgkin Lymphoma,B Cell
Burkitt Lymphoma
Primary Mediastinal Lymphoma
Primary CNS Lymphoma
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Burkitt Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Cytarabine
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Melphalan
Ifosfamide
Isophosphamide mustard
Doxorubicin
Liposomal doxorubicin
Methotrexate
Etoposide
Etoposide phosphate
Vincristine
Idarubicin
Carboplatin
BB 1101
Conditions: Keywords:
B-cell mature non-Hodgkin's lymphoma
Burkitt's lymphoma
Diffuse large B-cell lymphoma
primary mediastinal lymphoma, primary CNS lymphoma
rituximab
children, adolescents
treatment
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate
Description:
For patients with very limited disease (R1- stage I/II СR), the addition of rituximab
might allow the omission of anthracyclines and vincristine without jeopardizing survival
rates but reducing acute and long term toxicities. In this treatment arm, it is tested
whether the event-free survival is similar to that of the historical control
Arm group label:
R1: stage I and II
Intervention type:
Drug
Intervention name:
Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine
Description:
R2: Drug: Rituximab 2 doses of Rituximab (375 mg/m²) before the start of the first
chemotherapy cycle, 2 doses of Rituximab before the start of the second chemotherapy
cycle
Arm group label:
R2: incomplete, stage I and II
Intervention type:
Drug
Intervention name:
Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine
Description:
2 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, 2
doses of Rituximab before the start of the second
Arm group label:
R3: incomplete, stage III and LDH < 2 x ULN
Intervention type:
Drug
Intervention name:
Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU/ BCNU, Melphalan, Idarubicin
Description:
Rituximab 4 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy
cycle, Further
Arm group label:
R4: stage III and LDH ≥ 2 x ULN, stage IV/B-AL and CNS negative; CNS +
Summary:
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
Detailed description:
Detailed Description:
Risk group stratification:
R1: resection status: complete, stage I and II R2: resection status: incomplete, stage I
and II R3: resection status: incomplete, stage III and LDH < 2 x ULN R4: resection
status: incomplete, stage III and LDH ≥ 2 x ULN, stage IV/B-AL and CNS negative; CNS +
For patients with very limited disease (R1- stage I/II СR), the addition of rituximab
might allow the omission of anthracyclines and vincristine without jeopardizing survival
rates but reducing acute and long term toxicities. In this treatment arm, it is tested
whether the event-free survival is similar to that of the historical control For patients
with limited disease (R2- stage I/II NR), the addition of rituximab might allow the
omission of anthracyclines without jeopardizing survival rates but reducing acute and
long term toxicities.
For patients with limited disease (R3 - stage III and LDH < 2 x ULN ), the addition of
rituximab might allow reduce the number of blocks to four without jeopardizing survival
rates but reducing toxicities For patients with obligate factors of poor prognosis
(additional adverse cytogenetic findings (TP-53, 11qLOH) it is tested whether the
event-free survival can be improved by adding rituximab and adding blocks R-VICI
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
1 Day
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
Address:
City:
Moscow
Zip:
117198
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Yulia Abugova
Start date:
May 25, 2022
Completion date:
May 16, 2027
Lead sponsor:
Agency:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Agency class:
Other
Source:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518383
