NCT01622439 (VALFRID) is a Phase 1/Phase 2 clinical trial of Valproate in Diffuse Large B-cell Lymphoma, sponsored by Lund University Hospital.

Who is sponsoring NCT01622439?

NCT01622439 is sponsored by Lund University Hospital.

What drugs are being tested in NCT01622439?

Interventions in NCT01622439: Valproate, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone.

What condition does NCT01622439 study?

NCT01622439 studies Diffuse Large B-cell Lymphoma.

Is NCT01622439 still recruiting?

NCT01622439 is currently completed. Last updated 9 March 2018.

Last reviewed 2018-03-09 · How we verify

NCT01622439: VALFRID

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

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

Completed Phase 1/Phase 2 Last updated 9 March 2018

What this trial tests

Phase 1/Phase 2 trial testing Valproate in Diffuse Large B-cell Lymphoma in 50 participants. Completed in 1 March 2018.

Timeline

1 June 2012

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	Lund University Hospital
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2012
Primary completion	1 March 2018
Estimated completion	1 March 2018
Sites	1 location across Sweden

Drugs / interventions tested

Valproate — full drug profile →
Rituximab — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
Doxorubicin
Vincristine (vincristine) — full drug profile →
Prednisone (prednisone) — full drug profile →

Conditions studied

Diffuse Large B-cell Lymphoma — all drugs for Diffuse Large B-cell Lymphoma →

Sponsor

Lund University Hospital

Who can join

Adults 18 to 80, any sex, with Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Establishment of maximum tolerable dose of valproate.
Time frame: Participating patients will be followed during study treatment (6 cycles of chemotherapy); 12 weeks or 18 weeks depending on cycle length (14 or 21 days).

Sponsor's own description

Patients with previously untreated diffuse large B-cell lymphoma will receive standard treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD 20-expression. Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.

Publications & conference data

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

Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
The epigenetic hallmarks of immune cells in cancer.
Ji Y, Xiao C, Fan T, Deng Z, et al · · 2025 · cited 28× · PMID 40038722 · DOI 10.1186/s12943-025-02255-4
Valproate in combination with rituximab and CHOP as first-line therapy in diffuse large B-cell lymphoma (VALFRID).
Drott K, Hagberg H, Papworth K, Relander T, et al · · 2018 · cited 24× · PMID 29903707 · DOI 10.1182/bloodadvances.2018019240
Recent Advances in the Targeting of Epigenetic Regulators in B-Cell Non-Hodgkin Lymphoma.
Ribeiro ML, Reyes-Garau D, Armengol M, Fernández-Serrano M, et al · · 2019 · cited 20× · PMID 31681423 · DOI 10.3389/fgene.2019.00986
The histone deacetylase inhibitor valproic acid sensitizes diffuse large B-cell lymphoma cell lines to CHOP-induced cell death.
Ageberg M, Rydström K, Relander T, Drott K. · · 2013 · cited 18× · PMID 23573362
Epimutational profile of hematologic malignancies as attractive target for new epigenetic therapies.
Fratta E, Montico B, Rizzo A, Colizzi F, et al · · 2016 · cited 17× · PMID 27329599 · DOI 10.18632/oncotarget.10033
Pharmacologically relevant doses of valproate upregulate CD20 expression in three diffuse large B-cell lymphoma patients in vivo.
Damm JK, Gordon S, Ehinger M, Jerkeman M, et al · · 2015 · cited 17× · PMID 25973343 · DOI 10.1186/2162-3619-4-4
Histone Modifications and Their Targeting in Lymphoid Malignancies.
Fernández-Serrano M, Winkler R, Santos JC, Le Pannérer MM, et al · · 2021 · cited 10× · PMID 35008680 · DOI 10.3390/ijms23010253

Verify or expand the search:

Other trials of Valproate

Trials testing the same drug.

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Other recruiting trials for Diffuse Large B-cell Lymphoma

Currently open trials in the same condition.

NCT06977711 — Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large · Phase 1 · recruiting
NCT06846463 — Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+ · Phase 2 · recruiting
NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers · Phase 1 · active not recruiting
NCT06651853 — Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL · Phase 2 · recruiting
NCT06503263 — Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL · Phase 2 · recruiting

Other Lund University Hospital trials

Trials by the same sponsor.

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NCT06248996 — a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Ne · Phase 3 · recruiting
NCT06840639 — The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region. · completed

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 NCT01622439 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Lund University Hospital
Last refreshed: 9 March 2018

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/NCT01622439.

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