Who is sponsoring NCT04516655?

NCT04516655 is sponsored by Fudan University.

What drugs are being tested in NCT04516655?

Interventions in NCT04516655: chidamide combined with rituximab and high-dose methotrexate.

What condition does NCT04516655 study?

NCT04516655 studies Central Nervous System Lymphoma.

Is NCT04516655 still recruiting?

NCT04516655 is currently status unknown. Last updated 18 August 2020.

Last reviewed 2020-08-18 · How we verify

NCT04516655: C-R-HDMTX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients

Status unknown Phase 2 Last updated 18 August 2020

What this trial tests

Phase 2 trial testing chidamide combined with rituximab and high-dose methotrexate in Central Nervous System Lymphoma in 51 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 September 2021

30 August 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	1 September 2020
Primary completion	1 September 2021
Estimated completion	30 August 2023

Drugs / interventions tested

chidamide combined with rituximab and high-dose methotrexate — full drug profile →

Conditions studied

Central Nervous System Lymphoma — all drugs for Central Nervous System Lymphoma →

Sponsor

Fudan University

Who can join

Adults 18 to 80, any sex, with Central Nervous System Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the efficacy, safety and patient reported outcomes of chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma. The primary study endpoint will be complete response (CR) rate as assessed by the investigator. The hypothesis is previously untreated patients with primary central nervous system lymphoma could achieve a CR rate of 80% with C-R-HDMTX.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914
Novel insights into the biomarkers and therapies for primary central nervous system lymphoma.
Zhai Y, Zhou X, Wang X. · · 2022 · cited 7× · PMID 35558005 · DOI 10.1177/17588359221093745
New hopes and challenges in targeted therapy and immunotherapy for primary central nervous system lymphoma.
Yang C, Ren X, Cui Y, Jiang H, et al · · 2025 · cited 4× · PMID 40040699 · DOI 10.3389/fimmu.2025.1438001

Verify or expand the search:

Other recruiting trials for Central Nervous System Lymphoma

Currently open trials in the same condition.

NCT07416890 — Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Ref · Phase 2 · recruiting
NCT06213636 — Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL). · Phase 1, PHASE2 · recruiting
NCT05698147 — Selinexor in Combination With MTX+Ritu to Treat R/R CNSL · Phase 1, PHASE2 · recruiting
NCT05625594 — Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/Mem T-lymphocytes) · Phase 1 · recruiting
NCT05651178 — Human CD19-CD22 Targeted T Cells Injection for Refractory/Relapsed Central Nervous System Leukemia/Lymphoma Patients · EARLY_PHASE1 · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04516655 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fudan University
Last refreshed: 18 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04516655.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing