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)

NCT03479918 | Unknown Phase 3

• 1 other identifier: HGBL DH and HGBL NOS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise Specified.

Conditions

Lymphoma, High-Grade

Outcome Measures

Primary Outcomes (3)

• Overall survival

  Overall survival

  2 years

• Relapse-free survival

  Relapse-free survival

  2 years

• Progression

  Frequency of progression

  2 years

Secondary Outcomes (2)

• Complete remission

  1 year

• Partial remission

  1 year

Other Outcomes (1)

• Probability of relapse or progression

  2 years

Study Arms (4)

R-DA-EPOCH-21

ACTIVE COMPARATOR

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.

Drug: R-DA-EPOCH-21

R-BL-M-04

ACTIVE COMPARATOR

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.

Drug: R-BL-M-04

R-DA-EPOCH-21 + auto-SCT

ACTIVE COMPARATOR

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.

Drug: R-DA-EPOCH-21 + auto-SCT

R-BL-M-04 + auto-SCT

ACTIVE COMPARATOR

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.

Drug: R-BL-M-04 + auto-SCT

Interventions

R-DA-EPOCH-21 DRUG

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.

Also known as: R-DA-EPOCH

R-DA-EPOCH-21

R-BL-M-04 DRUG

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-BL-M-04

R-DA-EPOCH-21 + auto-SCT DRUG

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.

Also known as: R-DA-EPOCH + auto-SCT

R-DA-EPOCH-21 + auto-SCT

R-BL-M-04 + auto-SCT DRUG

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.

R-BL-M-04 + auto-SCT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Pregnancy.

Sponsors & Collaborators

• Elena N.Parovichnikova: lead

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Elena Parovichnokva, PhD

  National Research Center for Hematology, Moscow, Russian Federation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Misyurina, PhD

CONTACT

9096373249; anna.lukina1@gmail.com

Sergey Kravchenko, PhD

CONTACT

+74956132446; krav-hsc-ramn@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of BMT department, National Research Center for Hematology, Russia

Model Details: Factorial Assignment

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 27, 2018
• Study Start: March 15, 2018
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2024
• Last Updated: March 27, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)