Romidepsin

Generic Name: Romidepsin

Brand Names: Istodax

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₆N_₄O_₆S_₂

CAS Number: 128517-07-7

Unique Ingredient Identifier: CX3T89XQBK

Background: Romidepsin is a selective inhibitor of histone deacetylase, approved in the US in 2009 for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Indication: 用于在已接受至少1次既往全身治疗的患者中皮肤T-细胞淋巴瘤的治疗(CTCL)。

Associated Conditions: Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trials

Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents

Phase 1

Recruiting

Conditions: Bladder Cancer

Interventions: Drug: Romidepsin
Drug: Durvalumab

First Posted Date: 2025-05-09

Last Posted Date: 2025-05-09

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 12

Registration Number: NCT06963346

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load

Phase 1

Recruiting

Conditions: HIV-1-infection, Subtype b

Interventions: Drug: Decitabine cycle 1
Drug: Romidepsin cycle 1
Drug: Decitabine cycle 2
Drug: Romidepsin cycle 2
Drug: Decitabine cycle 3
Drug: Romidepsin cycle 3
Drug: Decitabine cycle 4
Drug: Romidepsin cycle 4

First Posted Date: 2022-02-08

Last Posted Date: 2024-10-30

Lead Sponsor: ANRS, Emerging Infectious Diseases

Target Recruit Count: 15

Registration Number: NCT05230368

Locations: 🇧🇪
CHU Saint-Pierre, Bruxelles, Belgium

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

Phase 1

Completed

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

Interventions: Drug: Parsaclisib
Drug: Romidepsin

First Posted Date: 2021-02-26

Last Posted Date: 2025-01-17

Lead Sponsor: Walter Hanel

Target Recruit Count: 5

Registration Number: NCT04774068

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

Phase 2

Recruiting

Conditions: PTCL

Interventions: Drug: Azacytidine
Drug: Romidepsin
Drug: Belinostat
Drug: Pralatrexate
Drug: Gemcitabine

First Posted Date: 2021-02-10

Last Posted Date: 2024-08-07

Lead Sponsor: University of Virginia

Target Recruit Count: 50

Registration Number: NCT04747236

Locations: 🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
University of Virginia, Charlottesville, Virginia, United States

and more 2 locations

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Phase 1

Withdrawn

Conditions: Adult T-cell Leukemia/Lymphoma
Extranodal NK-/T-cell Lymphoma, Nasal Type
Enteropathy-Associated T-Cell Lymphoma
Monomorphic Epiteliotrophic Intestinal T-cell Lymphoma
Hepatosplenic T-cell Lymphoma

Interventions: Drug: CC-486 (5-azacitidine)
Drug: Duvelisib
Drug: Romidepsin
Drug: Doxorubicin

First Posted Date: 2020-11-23

Last Posted Date: 2022-11-04

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04639843

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies

Phase 1

Active, not recruiting

Conditions: Cutaneous T-Cell Lymphoma
Mature T-cell Malignancies
Peripheral T-Cell Lymphoma
Relapsed/ Refractory T-cell Malignancies

Interventions: Drug: Romidepsin
Drug: Lenalidomide
Drug: CC-486 (5-azacitidine)
Drug: Dexamethasone

First Posted Date: 2020-06-25

Last Posted Date: 2024-07-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT04447027

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer

Phase 1

Active, not recruiting

Conditions: Pancreatic Adenocarcinoma
Pancreas Cancer
Pancreatic Ductal Adenocarcinoma

Interventions: Drug: nab-Paclitaxel
Drug: Romidepsin
Drug: Durvalumab
Drug: Azacitidine
Drug: Lenalidomide capsule
Drug: Gemcitabine

First Posted Date: 2020-02-06

Last Posted Date: 2023-05-01

Lead Sponsor: GWT-TUD GmbH

Target Recruit Count: 75

Registration Number: NCT04257448

Locations: 🇩🇪
Universitätsklinikum Essen, Essen, Germany
🇩🇪
Universitätsmedizin Göttingen, Göttingen, Germany
🇩🇪
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

and more 6 locations

Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma

Phase 1

Withdrawn

Conditions: Lymphoma, T-Cell

Interventions: Drug: Copanlisib
Drug: Romidepsin

First Posted Date: 2020-01-18

Last Posted Date: 2020-08-13

Lead Sponsor: Columbia University

Registration Number: NCT04233697

Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma

Phase 1

Completed

Conditions: T Cell Lymphoma

Interventions: Drug: Tenalisib
Drug: Romidepsin

First Posted Date: 2018-12-10

Last Posted Date: 2022-10-28

Lead Sponsor: Rhizen Pharmaceuticals SA

Target Recruit Count: 33

Registration Number: NCT03770000

Locations: 🇺🇸
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
Rush University Cancer Center, Chicago, Illinois, United States

and more 12 locations

ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma

Completed

Conditions: Lymphoma, T-Cell, Peripheral

Interventions: Drug: Istodax

First Posted Date: 2018-11-15

Last Posted Date: 2023-12-06

Lead Sponsor: Celgene

Target Recruit Count: 150

Registration Number: NCT03742921

Locations: 🇯🇵
Nihon Seimei Hospital, Osaka, Japan

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