R-BL-M-04 Versus R-(DA)-EPOCH and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit (HGBL DH) and High-Grade B-cell Lymphoma Not Otherwise Specified (HGBL NOS)
NCT ID: NCT03479918
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2018-03-15
2024-03-15
Brief Summary
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Detailed Description
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the first arm R-DA-EPOCH-21 the second arm R-BL-M-04 the third arm R-DA-EPOCH-21 + auto-SCT the fourth arm of R-BL-M-04 + auto-SCT Patients who achieved complete remission after 6 cycles of R-DA-EPOCH-21 or 4 cycles of R-BL-M-04 immunochemotherapy continue to be under observation (1st and 2nd arms) or continue treatment with Rituximab + BCNU+Etoposid+Ara-C+Melphalan (R-BEAM) followed by auto-SCT (3rd and 4th arms).
Patients who did not achieve complete remission with PET-CT data (4-5 Deauville points) are removed from the protocol and undergoing second-line therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-DA-EPOCH-21
The protocol involves 4-6 cycles. Intrathecal administration of dexamethasone 4 mg, methotrexate 15 mg and cytarabine 30 mg is required once during chemotherapy. In case of CNS involvement intrathecal administration is repeated 3 times a week till the normal cell count in cerebrospinal liquid.
R-DA-EPOCH-21
R-DA-EPOCH-21 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-BL-M-04
Course A:
Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Methotrexate 1500 mg/m2 12 h IV 1 day, Ifosfamide 800 mg/m2/day 1 h IV 1 - 5 days, Etoposide 100 mg/m2/day IV 4, 5 days, Doxorubicin 50 mg/m2/day IV day 3, Vincristine 2 mg IV 1 day, Cytarabine 150 mg/m2/day IV 1 h 4, 5 days.
Course C:
Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Methotrexate 1500 mg/m2 12 h IV 1 day, Vinblastine 5 mg/m2 IV day 1, Cytarabine 2000 mg/m2/day IV 3 h 2, 3 days, Etoposide 150 mg/m2/day IV 3-5 days.
Intrathecal administration of dexamethasone 4 mg, methotrexate 15 mg and cytarabine 30 mg is required once during chemotherapy. In case of CNS involvement intrathecal administration is repeated 3 times a week till the normal cell count in cerebrospinal liquid.
R-BL-M-04
R-BL-M-04 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-DA-EPOCH-21 + auto-SCT
The protocol involves 4-6 cycles. Patients with complete remission after 4 cycles undergo auto-SCT.
Intrathecal administration of dexamethasone 4 mg, methotrexate 15 mg and cytarabine 30 mg is required once during chemotherapy. In case of CNS involvement intrathecal administration is repeated 3 times a week till the normal cell count in cerebrospinal liquid.
R-DA-EPOCH-21 + auto-SCT
R-DA-EPOCH-21 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-BL-M-04 + auto-SCT
The protocol involves 4 cycles. Patients with complete remission after 4 cycles undergo auto-SCT.
Intrathecal administration of dexamethasone 4 mg, methotrexate 15 mg and cytarabine 30 mg is required once during chemotherapy. In case of CNS involvement intrathecal administration is repeated 3 times a week till the normal cell count in cerebrospinal liquid.
R-BL-M-04 + auto-SCT
R-BL-M-04 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
Interventions
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R-DA-EPOCH-21
R-DA-EPOCH-21 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-BL-M-04
R-BL-M-04 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-DA-EPOCH-21 + auto-SCT
R-DA-EPOCH-21 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
R-BL-M-04 + auto-SCT
R-BL-M-04 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No previous treatment with chemotherapy and/or radiation therapy of DLBCL
3. Informed consent of the patient.
Exclusion Criteria
2. HIV-associated lymphoma
3. Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction.
4. Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumour conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome).
5. Liver failure (except cases with liver tumour infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%.
6. Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea \> 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days).
7. Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumour infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment.
8. Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related to specific infiltration of a central nervous system.
9. Decompensated diabetes.
11\. Pregnancy.
18 Years
60 Years
ALL
No
Sponsors
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Elena N.Parovichnikova
NETWORK
Responsible Party
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Elena N.Parovichnikova
Head of BMT department, National Research Center for Hematology, Russia
Principal Investigators
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Elena Parovichnokva, PhD
Role: PRINCIPAL_INVESTIGATOR
National Research Center for Hematology, Moscow, Russian Federation
Locations
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National Research Center for Hematology
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HGBL DH and HGBL NOS
Identifier Type: -
Identifier Source: org_study_id
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