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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05054426
Other study ID # PUMCH-NHL-011
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 8, 2021
Est. completion date October 8, 2025

Study information

Verified date September 2021
Source Peking Union Medical College Hospital
Contact Wei Wang, MD.
Phone 8613810131294
Email wangweipumc@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In this prospective, phase III, multicenter, randomized, controlled study, the investigatirs aim to compare the efficacy of intravenous MTX(IV arm) at a dose of 1g/m2 with intrathecal MTX(IT arm) in terms of preventing CNS relapse. All the patients will recieve RCHOP regimen as front-line treatment of DLBCL. Patients in IV arm will recieve 4 course of IV MTX, which is incorporated into the RCHOP, naming R-MTX-CHOP regimen. Patients in IT arm will be given intrathecal MTX for 4 courses (one time for each course). 2 year CNS relapse rate is the primary endpoint while 2 year PFS, 2 year OS and safety are the secondary endpoint.


Recruitment information / eligibility

Status Recruiting
Enrollment 488
Est. completion date October 8, 2025
Est. primary completion date October 8, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Drug:
Methotrexate
intravenous versus intrathecal methotrexate

Locations

Country Name City State
China Peking union medical college hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & 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/m(2) incorporated into RCHOP prevented CNS relapse in high-risk DLBCL patients: A prospective, histor — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 progression free survival from diagnosis to any event including progression, relapse and death 2 year
Secondary overall survival from diagnosis to death 2 year
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