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)

March 26, 2018 updated by: Elena N.Parovichnikova

Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-BL-M-04 and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise Specified

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 125167
        • Recruiting
        • National Research Center for Hematology
        • Contact:
        • Sub-Investigator:
          • Sergey Kravchenko, MD, PhD
        • Sub-Investigator:
          • Anna Misyurina, MD, PhD
        • Sub-Investigator:
          • Aminat Magomedova, MD, PhD
        • Sub-Investigator:
          • Sergey Kulikov, PhD
        • Sub-Investigator:
          • Alla Kovrigina, PhD
        • Sub-Investigator:
          • Tatiana Obukhova, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. First established the diagnosis of HGBL DH or HGBL-NOS.
  2. No previous treatment with chemotherapy and/or radiation therapy of DLBCL
  3. Informed consent of the patient.

Exclusion Criteria:

  1. Pretreated lymphoma.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • R-DA-EPOCH
Active Comparator: 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.
Drug: 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.
Active Comparator: 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.
Drug: 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.
Other Names:
  • R-DA-EPOCH + auto-SCT
Active Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Overall survival
2 years
Relapse-free survival
Time Frame: 2 years
Relapse-free survival
2 years
Progression
Time Frame: 2 years
Frequency of progression
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission
Time Frame: 1 year
Frequency of complete remission
1 year
Partial remission
Time Frame: 1 year
Frequency of partial remission
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probability of relapse or progression
Time Frame: 2 years
Probability of relapse or progression
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elena N.Parovichnikova

Investigators

  • Principal Investigator: Elena Parovichnokva, PhD, National Research Center for Hematology, Moscow, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Anticipated)

March 15, 2021

Study Completion (Anticipated)

March 15, 2024

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGBL DH and HGBL NOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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