Status:
UNKNOWN
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)
Lead Sponsor:
Elena N.Parovichnikova
Conditions:
Lymphoma, High-Grade
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-BL-04 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with Hig...
Detailed Description
Patients initially are randomized into 4 arms: 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...
Eligibility Criteria
Inclusion
- First established the diagnosis of HGBL DH or HGBL-NOS.
- No previous treatment with chemotherapy and/or radiation therapy of DLBCL
- Informed consent of the patient.
Exclusion
- Pretreated lymphoma.
- HIV-associated lymphoma
- Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction.
- 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).
- 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%.
- 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).
- 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.
- Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related to specific infiltration of a central nervous system.
- Decompensated diabetes.
- 11\. Pregnancy.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03479918
Start Date
March 15 2018
End Date
March 15 2024
Last Update
March 27 2018
Active Locations (1)
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1
National Research Center for Hematology
Moscow, Russia, 125167