NCT02777736

Brief Summary

Comparison of cumulative incidence of CNS relapses in patients with diffuse large B-cell lymphoma with intermediate or high risk of CNS relapse treated with CNS prophylaxis: either with 2 doses of intravenous methotrexate 3g/m2 i.v.(arm A) or 6 doses of intrathecal methotrexate 12mg (arm B) and in patients with low risk of CNS relapse without CNS prophylaxis (arm C).

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
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2015

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

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

July 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

3.4 years

First QC Date

May 12, 2016

Last Update Submit

June 3, 2016

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Lymphoma, B cellCentral nervous system relapseMethotrexateIntrathecal chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of CNS relapse in patients treated either with methotrexate i.v. or methotrexate i.t. or without CNS prophylaxis

    1 year

Secondary Outcomes (4)

  • Complete remission rate

    1 year

  • Overall response rate

    1 year

  • Overall survival

    2 years

  • Progression-free survival

    2 years

Study Arms (3)

Arm A - Methotrexate i.v.

EXPERIMENTAL

Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive 2 cycles of methotrexate 3g/m2 i.v. after the 3rd and 6th cycle of systemic chemotherapy (R CHOP or DA EPOCH R).

Drug: Methotrexate

Arm B - Methotrexate i.t.

ACTIVE COMPARATOR

Patients with risk factors for CNS relapse ≥ 2 or with occult meningeal involvement will receive intrathecal methotrexate 12mg in each cycle of systemic chemotherapy (6x).

Drug: Methotrexate

Arm C - no Methotrexate

NO INTERVENTION

Patients with 0-1 risk factor for CNS relapse will not receive CNS prophylaxis.

Interventions

MethotrexateDRUG

i.v. or intrathecal CNS prophylaxis

Also known as: Methotrexate,manufactured by EBEWE, Methotrexate, manufactured by HOSPIRA
Arm A - Methotrexate i.v.Arm B - Methotrexate i.t.

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed DLBCL
  • age 18-72 years
  • signed informed consent with the study
  • first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR

You may not qualify if:

  • DLBCL and concomitant initial CNS involvement
  • PMBL (primary mediastinal B-cell lymphoma)
  • treatment with another chemotherapy than R CHOP or DA EPOCH R
  • HIV positive, or active hepatitis B or C
  • other concomitant serious disease (based on the decision of the physician-investigator)
  • non-compliance of a patient
  • any contraindication for application of anthracycline based chemotherapy or high dose methotrexate
  • pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Brno-Bohunice

Brno, 62500, Czechia

RECRUITING

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

RECRUITING

University Hospital Ostrava

Ostrava, 708 52, Czechia

RECRUITING

University Hospital Pilsen

Pilsen, 304 60, Czechia

RECRUITING

University Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

RECRUITING

General University Hospital Prague

Prague, 12808, Czechia

RECRUITING

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, B-Cell

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Heidi Mocikova, M.D., Ph.D.

    University Hospital Kralovske Vinohrady, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

  • Marek Trněný, prof.M.D.

    General University Hospital, Prague

    STUDY DIRECTOR

Central Study Contacts

Heidi Mocikova, M.D., Ph.D.

CONTACT

+420267163554heidi.mocikova@fnkv.cz

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 19, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

June 6, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

CZ(6)