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)

Associated Therapies: -

Clinical Trials

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas

Phase 1

Completed

Conditions: Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Refractory Mantle Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Follicular Lymphoma
Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Recurrent Burkitt Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Alisertib
Other: Laboratory Biomarker Analysis
Drug: Romidepsin

First Posted Date: 2013-07-11

Last Posted Date: 2019-01-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 26

Registration Number: NCT01897012

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma

Phase 1

Completed

Conditions: Peripheral T-Cell Lymphoma
Diffuse Large B-Cell Lymphoma

Interventions: Drug: Gemcitabine
Drug: Dexamethasone
Drug: Cisplatin
Drug: Romidepsin

First Posted Date: 2013-05-03

Last Posted Date: 2023-08-04

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 21

Registration Number: NCT01846390

Locations: 🇨🇦
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
🇨🇦
Odette Cancer Centre, Toronto, Ontario, Canada
🇨🇦
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

and more 3 locations

Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma
Non-Hodgkin's Lymphoma

Interventions: Drug: Romidepsin
Drug: Lenalidomide

First Posted Date: 2012-12-24

Last Posted Date: 2024-11-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 49

Registration Number: NCT01755975

Locations: 🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Saint Francis/Mount Sinai Regional Cancer Center, Hartford, Connecticut, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

and more 4 locations

Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma

Phase 1

Terminated

Conditions: Stage IA Mycosis Fungoides/Sezary Syndrome
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IIB Mycosis Fungoides/Sezary Syndrome
Recurrent Mycosis Fungoides/Sezary Syndrome
Stage IVB Mycosis Fungoides/Sezary Syndrome
Stage IIA Mycosis Fungoides/Sezary Syndrome
Stage IIIB Mycosis Fungoides/Sezary Syndrome
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IB Mycosis Fungoides/Sezary Syndrome

Interventions: Drug: carfilzomib
Drug: romidepsin
Other: laboratory biomarker analysis

First Posted Date: 2012-11-30

Last Posted Date: 2019-08-29

Lead Sponsor: Northwestern University

Target Recruit Count: 7

Registration Number: NCT01738594

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

Phase 1

Active, not recruiting

Conditions: Neuroendocrine Neoplasm
Recurrent Lung Carcinoma
Stage III Pancreatic Cancer AJCC v6 and v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIC Colorectal Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Stage IV Colorectal Cancer AJCC v7
Stage IV Pancreatic Cancer AJCC v6 and v7
Lymphoma
Recurrent Adult Soft Tissue Sarcoma

Interventions: Other: Pharmacological Study
Drug: Romidepsin

First Posted Date: 2012-07-11

Last Posted Date: 2024-10-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 37

Registration Number: NCT01638533

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 9 locations

Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma

Phase 1

Completed

Conditions: Recurrent Hepatosplenic T-Cell Lymphoma
Mycosis Fungoides
Recurrent Anaplastic Large Cell Lymphoma
Refractory Angioimmunoblastic T-Cell Lymphoma
Refractory Hepatosplenic T-Cell Lymphoma
Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified
Refractory Anaplastic Large Cell Lymphoma
Refractory Enteropathy-Associated T-Cell Lymphoma
Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Recurrent Enteropathy-Associated T-Cell Lymphoma

Interventions: Drug: Carboplatin
Drug: Etoposide
Drug: Ifosfamide
Drug: Romidepsin

First Posted Date: 2012-05-03

Last Posted Date: 2018-09-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 22

Registration Number: NCT01590732

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma

Phase 3

Completed

Conditions: Refractory Peripheral T-Cell Lymphoma
Relapsed Peripheral T-Cell Lymphoma

Interventions: Drug: Alisertib
Drug: Pralatrexate
Drug: Gemcitabine
Drug: Romidepsin

First Posted Date: 2011-12-01

Last Posted Date: 2018-07-31

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 271

Registration Number: NCT01482962

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)

Phase 1

Completed

Conditions: Lymphoma, T-cell, Peripheral

Interventions: Drug: Romidepsin

First Posted Date: 2011-10-20

Last Posted Date: 2019-02-11

Lead Sponsor: Celgene

Target Recruit Count: 51

Registration Number: NCT01456039

Locations: 🇯🇵
Nagoya Daini Red Cross Hospital, Nagoya, Aichi, Japan
🇯🇵
Sapporo Hokuyu Hospital, Sapporo, Hokkaido, Japan
🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan

and more 14 locations

A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

Phase 2

Completed

Conditions: Lymphoma
Cancer

Interventions: Drug: Romidepsin

First Posted Date: 2011-05-16

Last Posted Date: 2019-11-25

Lead Sponsor: Celgene

Target Recruit Count: 19

Registration Number: NCT01353664

Locations: 🇬🇧
Sarah Cannon Research UK, London, United Kingdom
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

Phase 1

Completed

Conditions: Hematologic Malignancy
Malignant Lymphoma

Interventions: Drug: Romidepsin
Drug: Ketoconazole

First Posted Date: 2011-03-29

Last Posted Date: 2019-11-25

Lead Sponsor: Celgene

Target Recruit Count: 15

Registration Number: NCT01324310

Locations: 🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States
🇬🇧
Sarah Cannon Research UK, London, United Kingdom

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy