NCT05054426

Brief Summary

Central nervous system (CNS) relapse is a devastating event of diffuse large B cell lymphoma (DLBCL). It occurs in 4%-7% of DLBCL in general and the rate is considerably higher in high-risk patients, resulting in a poor outcome.Effective methods of CNS prophylaxis have not yet been developed. Evidence for intrathecal or intravenous MTX are both controversial. In one previous study of PUMCH, IV MTX at a dose of 1g/m2 could significantly decrease the 2 year CNS relapse rate of high risk DLBCL(1.1% vs 12.1% for historic cohort, P=0.003). In current study, the investigators are aiming to confirm its efficacy through phase III study with intrathecal MTX as the controlled arm.

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
488

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2021

Typical duration 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

First Submitted

Initial submission to the registry

September 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

4 years

First QC Date

September 1, 2021

Last Update Submit

September 21, 2021

Conditions

Diffuse Large B Cell LymphomaCentral Nervous System Lymphoma

Keywords

central nervous system prophylaxismethotrexate

Outcome Measures

Primary Outcomes (1)

  • 2 year CNS relapse rate

    CNS relapse was defined as positive CSF conventionalcytology, CSF flow cytometry, or biopsy. For those who had clinical symptoms indicating a CNS involvement and typical lesions on MRI, the investigators also considered a recurrence

    2 year

Secondary Outcomes (2)

  • progression free survival

    2 year

  • overall survival

    2 year

Study Arms (2)

intravenous MTX

EXPERIMENTAL

intravenous methotrexate at a dose of 1g/m2 for 4 courses

Drug: Methotrexate

intrathecal MTX

EXPERIMENTAL

intrathecal methotrexate 10mg at a time for 4 courses

Drug: Methotrexate

Interventions

MethotrexateDRUG

intravenous versus intrathecal methotrexate

intrathecal MTXintravenous MTX

Eligibility Criteria

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

You may qualify if:

  • age ≥ 18 years
  • with high CNS risk, which was defined as involvement of more than one extranodal site, or involvement of particular extranodal sites such as bone marrow, breasts, testes, paranasal sinuses, epidural space, adrenal glands, kidney and female genital system;
  • first-line treatment planned to be RCHOP
  • absence of CNS involvement at presentation

You may not qualify if:

  • primary CNS lymphoma
  • already have CNS involvement at diagnosis
  • primary mediastinal lymphoma, intravascular large B-cell lymphoma, DLBCL leg-type, Burkitt lymphoma, high-grade lymphomas, double expressor lymphoma
  • with active infection or other malignancy
  • severe liver or kidney insufficiency
  • allergy to any medication we plan to use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (1)

  • Wang W, Zhang Y, Zhang L, Yang C, Feng J, Cai H, Chen M, Cao X, Zhuang J, Zhu T, Duan M, Zhang W, Li J, Zhou D. Intravenous methotrexate at a dose of 1 g/m2 incorporated into RCHOP prevented CNS relapse in high-risk DLBCL patients: A prospective, historic controlled study. Am J Hematol. 2020 Apr;95(4):E80-E83. doi: 10.1002/ajh.25723. Epub 2020 Jan 22. No abstract available.

    PMID: 31925808RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, 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

  • Daobin Zhou, MD.

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Wei Wang, MD.

CONTACT

8613810131294wangweipumc@163.com

Daobin Zhou, MD.

CONTACT

8613901113623zhoudb@pumch.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 23, 2021

Study Start

October 8, 2021

Primary Completion

October 8, 2025

Study Completion

October 8, 2025

Last Updated

September 23, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)