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

NCT04774068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-01-17

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Transformed Mycosis Fungoides
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory Transformed Mycosis Fungoides
  • T-Cell Non-Hodgkin Lymphoma

Interventions

DRUG

Parsaclisib

Given PO

DRUG

Romidepsin

Given IV

Sponsors & Collaborators

  • Walter Hanel

    lead OTHER

Principal Investigators

  • Walter Hanel, MD, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-10-27
Completion
2024-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774068 on ClinicalTrials.gov