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Status unknownNCT03123718Updated Apr 24, 2017

High-dose Intravenous Methotrexate Versus Intrathecal Methotrexate for Central Nervous System Prophylaxis in DLBCL

A Phase 3 interventional study of Intrathecal methotrexate and High-dose intravenous methotrexate in DLBCL, sponsored by Chonnam National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Chonnam National University Hospital · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a subgroup of patients with a high risk of CNS relapse.

Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested as an alternative approach. Considering the lack of evidence supporting the role of ITMTX, the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.

02

Conditions studied

  • DLBCL

Keywords

  • methotrexate
03

In context

Lead sponsor

Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥18 years \<80
  • Newly diagnosed, histologically confirmed DLBCL

  • High-risk of CNS recurrence at diagnosis:

    1. Age-adjusted IPI (aaIPI) ≥2 or IPI ≥4 with extranodal involvement of >1 site plus serum lactate dehydrogenase (LDH) > normal OR
    2. Involvement of high-risk locations: bone marrow, nasal or paranasal sinuses, testis, epidural disease (paravertebral or vertebra), breast, adrenal or kidney
  • Estimated life expectancy of more than 90 days
  • Performance status (ECOG) ≤ 2
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol

  • DLBCL or following subtypes:

    1. Primary mediastinal large B-cell lymphoma
    2. Grey zone lymphoma)
    3. Primary cutaneous DLBCL
  • Previous immunochemotherapeutic treatment for DLBCL other than short-term use of corticosteroids (≤ 8 days before randomization)
  • Previous radiotherapy
  • CNS involvement of DLBCL at diagnosis
  • HIV positive
  • Any contraindication for application of RCHOP or high dose methotrexate

  • Any of following laboratory results

    1. Absolute neutrophil count \< 1,500 cells/mm3 (1.5 x 109/L),
    2. Platelet count \< 100,000/mm3 (100 x 109/L), or \< 75,000 /mm3 in patients with bone marrow involvement,
    3. Serum aspartate transaminase or serum alanine transaminase ≥3.0 x upper limit of normal (ULN),
    4. Serum total bilirubin > 2 x ULN (with the exception of hemolytic anemia),
  • Serum creatinine >2.0 x ULN or creatinine clearance \<50 mL/min
  • Active cancer except curable basal cell carcinoma, cervical cancer in situ, and/or papillary thyroid cancer during the last five years
  • Ejection fraction \< 45% on echocardiography
  • Uncontrolled active hepatitis
  • Pregnancy or breast-feeding
  • Men and women of reproductive potential no agreeing to use an acceptable method of birth control during treatment
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
205 participants (estimated)

Study arms

  • Other
    Intrathecal Methotrexate

    Drug: Intrathecal methotrexate

  • Active comparator
    High-dose Intravenous Methotrexate

    Drug: High-dose intravenous methotrexate

Interventions

  • DrugIntrathecal methotrexate

    Intrathecal administration of 2nd, 3rd, and 4th doses of methotrexate 15 mg and hydrocortisone 50mg on day 2 or 3 of 2nd, 3rd, and 4th cycles of immunochemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP), respectively.

  • DrugHigh-dose intravenous methotrexate

    Intravenous administration of 1st and 2nd doses of methotrexate 3g/m2 on day 15 of 2nd and 6th cycles of immunochemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP), respectively. \* Dose of intravenous methotrexate will be reduced to 2g/m2 for patients aged \>70 years.

06

What researchers measure

Primary outcomes

  1. Cumulative incidence of CNS relapse

    The rate of relapse will be analyzed by the cumulative incidence method

    Time frame: 2 year

Secondary outcomes

  1. Toxicity

    Toxicity will be graded according to NCI-CTCAE v.4.03

    Time frame: 2 year

  2. Progression-free survival (PFS)

    PFS will be calculated from randomization to the date of CNS relapse and/or systemic disease progression, death, or last follow-up, as appropriate.

    Time frame: 2 year

07

Study locations

1 site
  • Chonnam National University Hwasun Hospital
    Hwasun-gun, Jeollanam-do 519-809, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03123718
Lead sponsor
Chonnam National University Hospital
Collaborators
Consortium for Improving Survival of Lymphoma
Responsible party
Deok-Hwan Yang (Principal Investigator, Chonnam National University Hospital) — Principal investigator
First posted
Apr 21, 2017
Start date
Jul 1, 2017 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Apr 24, 2017

Study contacts

Deok-Hwan Yang
Contact
drydh1685@hotmail.com
+82-61-379-7636
Seung-Ah Yahng
Contact
saymd@catholic.ac.kr
+82-32-280-5893

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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