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Clinical trialNCT04774068CompletedPhase 1Interventional

Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas

SponsorWalter HanelEnrollment5Recurrent Anaplastic Large Cell LymphomaRecurrent Mature T-Cell and NK-Cell Non-Hodgkin LymphomaRecurrent Primary Cutaneous T-Cell Non-Hodgkin LymphomaRecurrent Transformed Mycosis FungoidesRefractory Anaplastic Large Cell LymphomaRefractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma+3 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase I trial finds the appropriate parsaclisib dose level in combination with romidepsin for the treatment of T-cell lymphomas that have come back (relapsed) or that have not responded to standard treatment (refractory). The other goals of this trial are to find the proportion of patients whose cancer is put into complete remission or significantly reduced by romidepsin and parsaclisib, and to measure the effectiveness of romidepsin and parsaclisib in terms of patient survival. Romidepsin blocks certain enzymes (histone deacetylases) and acts by stopping cancer cells from dividing. Parsaclisib is a PI3K inhibitor. The PI3K pathway promotes cancer cell proliferation, growth, and survival. Parsaclisib, thus, may stop the growth of cancer cells by blocking PI3K enzymes needed for cell growth. Giving romidepsin and parsaclisib in combination may work better in treating relapsed or refractory T-cell lymphomas compared to either drug alone.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Walter Hanel, MD, PhD

    Ohio State University Comprehensive Cancer Center

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ParsaclisibRomidepsin
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Sept 2021
Primary completion
27 Oct 2024
Completion
27 Oct 2024
Last update posted
17 Jan 2025
Registered enrollment
5
Registry id
NCT04774068

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.