NCT02842931

Brief Summary

Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with DLBCL with intermediate and high risk.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

March 11, 2016

Last Update Submit

July 20, 2016

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

DLBCL, R-DA-EPOCH-21, R-mNHL-BFM-90, auto-SCT

Outcome Measures

Primary Outcomes (1)

  • complete response

    (physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy).

    168 day

Secondary Outcomes (3)

  • overall survival

    Five-year survival

  • disease-free survival

    Five-year survival

  • event-free survival

    Five-year survival

Study Arms (4)

R-DA-EPOCH-21

ACTIVE COMPARATOR

Protocol involves 6 cycles.

Drug: R-DA-EPOCH-21

R-DA-EPOCH-21 + auto-SCT

ACTIVE COMPARATOR

Protocol involves 6 cycles. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP

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

R-mNHL-BFM-90

ACTIVE COMPARATOR

Course A: Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Methotrexate 1000 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 25 mg/m2/day IV 1, 2 days, Vincristine 2 mg IV 1 day, Cytarabine 100 mg/m2/day IV 1 h 4, 5 days. Course B: Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Cyclophosphamide 200 mg/m2/day IV 1 h 1 - 5 days, Methotrexate 1000 mg/m2 12 h IV 1 day, Doxorubicin 25 mg/m2/day IV 4, 5 days, Vincristine 2 mg IV 1 day. Protocol involves 6 cycles : A-B-A-B-A-B. One cycle continues 21 days.

Drug: R-mNHL-BFM-90

R-mNHL-BFM-90 + auto-SCT

ACTIVE COMPARATOR

Protocol involves 6 cycles R-mNHL-BFM-90: A-B-A-B-A-B. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP

Drug: R-mNHL-BFM-90 + auto-SCT

Interventions

R-DA-EPOCH-21DRUG

R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI

R-DA-EPOCH-21
R-DA-EPOCH-21 + auto-SCTDRUG

R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI

R-DA-EPOCH-21 + auto-SCT
R-mNHL-BFM-90DRUG

R-mNHL-BFM-90 without auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI

R-mNHL-BFM-90
R-mNHL-BFM-90 + auto-SCTDRUG

R-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI

R-mNHL-BFM-90 + auto-SCT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed DLBCL,
  • No previous treatment with chemotherapy and/or radiation therapy of DLBCL
  • Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
  • Age 18-60 years.

You may not qualify if:

  • Transformation of mature cell lymphomas in DLBCL.
  • B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Hodgkin's lymphoma
  • B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma
  • DLBCL of central nervous system (CNS)
  • testicular DLBCL
  • Primary mediastinal large B-cell lymphoma
  • Pretreated DLBCL.
  • HIV-associated DLBCL
  • 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 tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome).
  • Liver failure (except cases with liver tumor 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 tumor 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 with specific infiltration of central nervous system.
  • Decompensated diabetes.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Center for Hematology

Moscow, 125167, Russia

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elena N Parovichnikova, MD PhD

    National Research Center for Hematology, Russia

    STUDY CHAIR

Central Study Contacts

Aminat Magomedova, MD, PhD

CONTACT

495-613-2446maminat@mail.ru

Sergay Kravchenko, MD PhD

CONTACT

495-613-2446krav-hsc-ramn@mail.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 11, 2016

First Posted

July 25, 2016

Study Start

February 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2023

Last Updated

July 25, 2016

Record last verified: 2016-07

Locations

RU(1)