Clinical Trials

Romidepsin has been evaluated in numerous clinical trials from phase 1 through phase 3 across a spectrum of oncologic and infectious conditions, including cutaneous T-cell lymphoma, peripheral T-cell lymphoma, solid tumors, and HIV infection. These studies reflect various recruitment statuses—including active, recruiting, completed, terminated, and withdrawn—and are sponsored by academic medical centers, research institutes, and pharmaceutical entities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04747236 RECRUITING
PTCL
University of Virginia
 2021-02-19 PHASE2
NCT06963346 RECRUITING
Bladder Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2025-06-24 PHASE1
NCT03278782 ACTIVE_NOT_RECRUITING
Recurrent Anaplastic Large Cell Lymphoma; Recurrent Angioimmunoblastic T-Cell Lymphoma; Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Angioimmunoblastic T-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
M.D. Anderson Cancer Center
 2017-11-14 PHASE1; PHASE2
NCT02393794 ACTIVE_NOT_RECRUITING
Triple-Negative Breast Cancer; Breast Cancer
Priyanka Sharma
 2015-07-17 PHASE1; PHASE2
NCT02783625 COMPLETED
Lymphoma; Relapsed/Refractory T-cell Lymphomas
Memorial Sloan Kettering Cancer Center
 2016-05-23 PHASE1
NCT05230368 COMPLETED
HIV-1-infection, Subtype b
ANRS, Emerging Infectious Diseases
 2022-12-14 PHASE1
NCT01908777 COMPLETED
T Cell Non-Hodgkin Lymphoma
Memorial Sloan Kettering Cancer Center
 2013-07-16 PHASE2
NCT04774068 COMPLETED
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
Walter Hanel
 2021-09-01 PHASE1
NCT04257448 COMPLETED
Pancreas Cancer; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma
GWT-TUD GmbH
 2020-05-25 PHASE1; PHASE2
NCT04447027 COMPLETED
Cutaneous T-Cell Lymphoma; Mature T-cell Malignancies; Peripheral T-Cell Lymphoma; Relapsed/ Refractory T-cell Malignancies
National Cancer Institute (NCI)
 2020-12-17 PHASE1
NCT02512497 COMPLETED
Cutaneous T-cell Lymphoma; T-Prolymphocytic Leukemia; T-Large Granulocytic Leukemia; T-Lymphoblastic Leukemia/Lymphoma; Peripheral T-Cell Lymphoma
Ohio State University Comprehensive Cancer Center
 2017-12-08 PHASE1
NCT01755975 COMPLETED
Multiple Myeloma; Non-Hodgkin's Lymphoma
Memorial Sloan Kettering Cancer Center
 2012-12 PHASE1; PHASE2
NCT03161223 RECRUITING
Lymphoma, T-Cell
University of Virginia
 2018-05-30 PHASE1; PHASE2
NCT02341014 COMPLETED
T-cell Lymphomas; Relapsed or Refractory
Memorial Sloan Kettering Cancer Center
 2015-01-02 PHASE1; PHASE2
NCT04639843 WITHDRAWN
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
National Cancer Institute (NCI)
 2022-11-03 PHASE1
NCT01947140 COMPLETED
Lymphoid Malignancies; Multiple Myeloma; Lymphoma; Hodgkin Lymphoma; Non-hodgkin Lymphoma
Jennifer Amengual
 2013-09-09 PHASE1; PHASE2
NCT03432741 TERMINATED
Breast Adenocarcinoma; Metastatic Breast Carcinoma; Recurrent Breast Carcinoma; Recurrent Hodgkin Lymphoma; Recurrent Mycosis Fungoides; Recurrent Non-Hodgkin Lymphoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Breast Carcinoma; Refractory Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Nodal Marginal Zone Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Stage IV Breast Cancer AJCC v6 and v7
Mayo Clinic
 2018-03-27 PHASE1
NCT02616965 COMPLETED
Cutaneous T-cell Lymphoma (CTCL)
Fox Chase Cancer Center
 2017-02-22 PHASE1
NCT04233697 WITHDRAWN
Lymphoma, T-Cell
Columbia University
 2020-02 PHASE1
NCT02512172 COMPLETED
Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2016-02-19 PHASE1
NCT03041012 COMPLETED
Hiv
Aarhus University Hospital
 2017-01-20 PHASE2
NCT03619278 WITHDRAWN
HIV Infections
Judit Pich
 2020-11-01 PHASE1; PHASE2
NCT03770000 COMPLETED
T Cell Lymphoma
Rhizen Pharmaceuticals SA
 2019-03-12 PHASE1; PHASE2
NCT03534180 COMPLETED
Anaplastic Large Cell Lymphoma; Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
City of Hope Medical Center
 2018-08-21 PHASE2
NCT03703375 COMPLETED
Lymphoma, T-Cell
Celgene
 2018-11-06 PHASE3
NCT03593018 COMPLETED
Relapsed Angioimmunoblastic T-Cell Lymphoma; Refractory Angioimmunoblastic T-cell Lymphoma
The Lymphoma Academic Research Organisation
 2018-11-09 PHASE3
NCT02850016 COMPLETED
Human Immunodeficiency Virus (HIV)
Rockefeller University
 2017-01-06 PHASE2
NCT02223208 COMPLETED
Peripheral T-cell Lymphomas (PTCL); PTCL-NOS; Angioimmunoblastic T-cell Lymphoma (AITL); ALK- Anaplastic Large Cell Lymphoma (ALCL); Nodal Peripheral T-Cell Lymphoma of T Follicular Helper Cell Origin
Fondazione Italiana Linfomi - ETS
 2014-09 PHASE1; PHASE2
NCT02281279 WITHDRAWN
B-cell Adult Acute Lymphoblastic Leukemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Hairy Cell Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Testicular Lymphoma; Waldenström Macroglobulinemia
Mayo Clinic
 2016-10 PHASE1; PHASE2
NCT03547700 TERMINATED
Lymphoma, T-Cell, Peripheral
University of Michigan Rogel Cancer Center
 2018-09-26 PHASE1; PHASE2
NCT02232516 COMPLETED
Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Peripheral T-cell Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IA Mycosis Fungoides/Sezary Syndrome; Stage IB Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIA Mycosis Fungoides/Sezary Syndrome; Stage IIB Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIIA Mycosis Fungoides/Sezary Syndrome; Stage IIIB Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IVA Mycosis Fungoides/Sezary Syndrome; Stage IVB Mycosis Fungoides/Sezary Syndrome
Northwestern University
 2015-06-11 PHASE2
NCT03141203 COMPLETED
Peripheral T Cell Lymphoma
University of Birmingham
 2015-07-13 PHASE1; PHASE2
NCT01998035 TERMINATED
Lymphoid Malignancies; Lymphoma; Hodgkin Lymphoma; Non-hodgkin Lymphoma
Columbia University
 2013-11 PHASE1; PHASE2
NCT01796002 COMPLETED
Peripheral T-cell Lymphoma
The Lymphoma Academic Research Organisation
 2013-01 PHASE3
NCT02181218 COMPLETED
Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell, Peripheral; Hodgkin Disease; Lymphoma, Large B-Cell, Diffuse
Washington University School of Medicine
 2015-02-04 PHASE1
NCT03770000 Completed
T Cell Lymphoma
Rhizen Pharmaceuticals SA
 2019-03-12 Phase 1|Phase 2
NCT01638533 COMPLETED
Glioma; Hematopoietic and Lymphoid Cell Neoplasm; Lymphoma; Metastatic Malignant Solid Neoplasm; Neuroendocrine Neoplasm; Recurrent Adult Soft Tissue Sarcoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Colorectal Carcinoma; Recurrent Head and Neck Carcinoma; Recurrent Lung Carcinoma; Recurrent Malignant Solid Neoplasm; Recurrent Melanoma; Recurrent Pancreatic Carcinoma; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Recurrent Prostate Carcinoma; Recurrent Renal Cell Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Chronic Lymphocytic Leukemia; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Stage III Breast Cancer AJCC v7; Stage III Colorectal Cancer AJCC v7; Stage III Cutaneous Melanoma AJCC v7; Stage III Lung Cancer AJCC v7; Stage III Pancreatic Cancer AJCC v6 and v7; Stage III Prostate Cancer AJCC v7; Stage III Renal Cell Cancer AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Stage IV Colorectal Cancer AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Stage IV Lung Cancer AJCC v7; Stage IV Pancreatic Cancer AJCC v6 and v7; Stage IV Prostate Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7; Unresectable Solid Neoplasm
National Cancer Institute (NCI)
 2012-08-03 PHASE1
NCT02061449 TERMINATED
Cutaneous T-cell Lymphoma
NYU Langone Health
 2014-03 PHASE1
NCT03355768 WITHDRAWN
Lymphoma, T-Cell, Peripheral
Jennifer Amengual
 2018-09-01 PHASE3
NCT01897012 COMPLETED
MYC Positive; Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Burkitt Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Follicular Lymphoma; Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements; Recurrent Hodgkin Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Burkitt Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Follicular Lymphoma; Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements; Refractory Hodgkin Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
National Cancer Institute (NCI)
 2013-07-17 PHASE1
NCT01902225 COMPLETED
Lymphoma; T-Cell Lymphoma; Cutaneous Lymphoma
Weiyun Ai
 2014-03-04 PHASE1
NCT01590732 COMPLETED
Mycosis Fungoides; Recurrent Anaplastic Large Cell Lymphoma; Recurrent Angioimmunoblastic T-Cell Lymphoma; Recurrent Enteropathy-Associated T-Cell Lymphoma; Recurrent Hepatosplenic T-Cell Lymphoma; Recurrent Peripheral T-Cell Lymphoma, Not Otherwise Specified; Refractory Anaplastic Large Cell Lymphoma; Refractory Angioimmunoblastic T-Cell Lymphoma; Refractory Enteropathy-Associated T-Cell Lymphoma; Refractory Hepatosplenic T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
M.D. Anderson Cancer Center
 2012-10-29 PHASE1
NCT01933594 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-05-05 PHASE1; PHASE2
NCT02616965 Active not recruiting
Cutaneous T-cell Lymphoma (CTCL)
Fox Chase Cancer Center|Seagen Inc.|Celgene Corporation
 2017-02-22 Phase 1
NCT02757248 WITHDRAWN
PTCL; CTCL
Anne Beaven, MD
 2016-11 PHASE1
NCT01738594 TERMINATED
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IA Mycosis Fungoides/Sezary Syndrome; Stage IB Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIA Mycosis Fungoides/Sezary Syndrome; Stage IIB Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIIA Mycosis Fungoides/Sezary Syndrome; Stage IIIB Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IVA Mycosis Fungoides/Sezary Syndrome; Stage IVB Mycosis Fungoides/Sezary Syndrome
Northwestern University
 2013-03-22 PHASE1
NCT01979276 TERMINATED
Multiple Myeloma
Weill Medical College of Cornell University
 2013-11 PHASE1; PHASE2
NCT02616874 COMPLETED
HIV
IrsiCaixa
 2016-02 PHASE1
NCT01938833 TERMINATED
HER2-negative Breast Cancer; Inflammatory Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2014-04 PHASE1; PHASE2
NCT01742793 TERMINATED
Hodgkin's Lymphoma; Mature T-cell Lymphoma; Multiple Myeloma
Yale University
 2012-10 PHASE1
NCT01846390 COMPLETED
Peripheral T-Cell Lymphoma; Diffuse Large B-Cell Lymphoma
Canadian Cancer Trials Group
 2013-10-01 PHASE1
NCT02203578 TERMINATED
Graft Versus Host Disease
Rutgers, The State University of New Jersey
 2014-11
NCT01537744 COMPLETED
Solid Tumors; Virally Mediated Cancers and Liposarcoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2012-02 PHASE1
NCT02616874 Completed
HIV
IrsiCaixa|Germans Trias i Pujol Hospital|Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia|Hospital Clinic of Barcelona|Hospital de Sant Pau|HIVACAT|University of Oxford|BCN Checkpoint
 2016-02 Phase 1
NCT02092116 COMPLETED
HIV I Infection
Bionor Immuno AS
 2014-03 PHASE1; PHASE2
NCT01456039 COMPLETED
Lymphoma, T-cell, Peripheral
Celgene
 2011-12-01 PHASE1; PHASE2
NCT01482962 COMPLETED
Relapsed Peripheral T-Cell Lymphoma; Refractory Peripheral T-Cell Lymphoma
Millennium Pharmaceuticals, Inc.
 2012-06-11 PHASE3
NCT00007345 COMPLETED
Cutaneous T Cell Lymphoma; Peripheral T Cell Lymphoma
National Cancer Institute (NCI)
 2001-03-08 PHASE2
NCT01822886 COMPLETED
Peripheral T-cell Lymphoma
Fondazione Italiana Linfomi - ETS
 2013-01 PHASE2
NCT01302808 COMPLETED
Lung Cancer; Metastatic Cancer
University of Texas Southwestern Medical Center
 2009-09 PHASE1
NCT00963274 COMPLETED
Leukemia; Lymphoma
Virginia Commonwealth University
 2010-04-26 PHASE1
NCT01913119 COMPLETED
Histologically Proven Extranodal NKTcell Lymphoma
Samsung Medical Center
 2013-07 EARLY_PHASE1
NCT01280526 COMPLETED
Peripheral T Cell Lymphoma
The Lymphoma Academic Research Organisation
 2011-01 PHASE1; PHASE2
NCT01353664 COMPLETED
Lymphoma; Cancer
Celgene
 2011-05-01 PHASE2
NCT01324323 COMPLETED
Hematologic Malignancy; Malignant Lymphoma
Celgene
 2011-04-01 PHASE1
NCT01324310 COMPLETED
Hematologic Malignancy; Malignant Lymphoma
Celgene
 2011-04-01 PHASE1
NCT00431990 UNKNOWN
Multiple Myeloma
Peter MacCallum Cancer Centre, Australia
 2006-11 PHASE1; PHASE2
NCT00383565 TERMINATED
Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
 2006-09 PHASE2
NCT00426764 COMPLETED
Peripheral T-cell Lymphoma
Celgene
 2007-06-19 PHASE2
NCT00048334 COMPLETED
Neoplasms
National Cancer Institute (NCI)
 2002-10-26 PHASE1
NCT00765102 TERMINATED
Multiple Myeloma
Celgene
 2008-09-01 PHASE2
NCT00098813 COMPLETED
Recurrent Thyroid Cancer; Stage IV Follicular Thyroid Cancer; Stage IV Papillary Thyroid Cancer
National Cancer Institute (NCI)
 2004-10 PHASE2
NCT00084682 COMPLETED
Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx
National Cancer Institute (NCI)
 2005-06 PHASE2
NCT00112463 COMPLETED
Adult Alveolar Soft-part Sarcoma; Adult Angiosarcoma; Adult Epithelioid Sarcoma; Adult Extraskeletal Chondrosarcoma; Adult Extraskeletal Osteosarcoma; Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Fibrous Histiocytoma; Adult Malignant Hemangiopericytoma; Adult Malignant Mesenchymoma; Adult Neurofibrosarcoma; Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Gastrointestinal Stromal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Adult Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
 2005-01-07 PHASE2
NCT00379639 COMPLETED
Pancreatic Cancer
Celgene
 2006-07-01 PHASE1
NCT00106431 COMPLETED
Cutaneous T-cell Lymphoma
Celgene
 2005-01-01 PHASE2
NCT00066638 COMPLETED
DS Stage II Plasma Cell Myeloma; DS Stage III Plasma Cell Myeloma; Refractory Plasma Cell Myeloma
National Cancer Institute (NCI)
 2003-06 PHASE2
NCT00091195 TERMINATED
Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
National Cancer Institute (NCI)
 2004-09 PHASE2
NCT00062075 COMPLETED
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Promyelocytic Leukemia (M3); Recurrent Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2003-05 PHASE2
NCT00086827 COMPLETED
Recurrent Small Cell Lung Cancer
National Cancer Institute (NCI)
 2004-05 PHASE2
NCT00106301 COMPLETED
Carcinoma, Renal Cell; Prostatic Neoplasms
Celgene
 2004-04-01 PHASE2
NCT00106418 COMPLETED
Prostate Cancer; Metastases
Celgene
 2003-05-07 PHASE2
NCT00114257 COMPLETED
Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
National Cancer Institute (NCI)
 2005-05 PHASE1
NCT00053963 COMPLETED
Blastic Phase Chronic Myelogenous Leukemia; Childhood Central Nervous System Germ Cell Tumor; Childhood Choroid Plexus Tumor; Childhood Chronic Myelogenous Leukemia; Childhood Craniopharyngioma; Childhood Grade I Meningioma; Childhood Grade II Meningioma; Childhood Grade III Meningioma; Childhood High-grade Cerebral Astrocytoma; Childhood Infratentorial Ependymoma; Childhood Low-grade Cerebral Astrocytoma; Childhood Spinal Cord Neoplasm; Childhood Supratentorial Ependymoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway and Hypothalamic Glioma; Refractory Chronic Lymphocytic Leukemia; Relapsing Chronic Myelogenous Leukemia; Unspecified Childhood Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2002-09 PHASE1
NCT00077194 COMPLETED
Lymphoma
National Cancer Institute (NCI)
 2004-01 PHASE2
NCT00098397 COMPLETED
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2005-02 PHASE2
NCT00079443 TERMINATED
Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Small Lymphocytic Lymphoma
National Cancer Institute (NCI)
 2004-01 PHASE2
NCT00098527 TERMINATED
Adenocarcinoma of the Esophagus; Adenocarcinoma of the Stomach; Recurrent Esophageal Cancer; Recurrent Gastric Cancer
National Cancer Institute (NCI)
 2004-10 PHASE2
NCT00042822 COMPLETED
Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
Memorial Sloan Kettering Cancer Center
 2002-05 PHASE2
NCT00084461 TERMINATED
Gastrinoma; Glucagonoma; Insulinoma; Metastatic Gastrointestinal Carcinoid Tumor; Pancreatic Polypeptide Tumor; Pulmonary Carcinoid Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Regional Gastrointestinal Carcinoid Tumor; Somatostatinoma
National Cancer Institute (NCI)
 2004-03 PHASE2
NCT00106613 COMPLETED
Carcinoma, Renal Cell; Neoplasm Metastasis
Celgene
 2003-05-01 PHASE2
NCT00077337 COMPLETED
Colorectal Cancer
SWOG Cancer Research Network
 2004-04 PHASE2
NCT00019318 COMPLETED
Lymphoma
National Cancer Institute (NCI)
 1997-08 PHASE1
NCT00024180 COMPLETED
Leukemia; Lymphoma
Ohio State University Comprehensive Cancer Center
 2002-01 PHASE1
NCT01445340 TERMINATED
Mycosis Fungoides; Cutaneous T-Cell Lymphoma; Neoplasms
National Cancer Institute (NCI)
 2007-04-21 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-21)

Check the Romidepsin (FK228) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Romidepsin is a prodrug that undergoes intracellular reduction to generate a sulfhydryl species that binds zinc in the active site of histone deacetylases 1 and 2, blocking enzymatic activity and inducing histone hyperacetylation along with cell cycle arrest and apoptosis. This epigenetic modulation inhibits tumor cell growth and upregulates death receptors, providing the biological foundation for its therapeutic efficacy in T-cell lymphomas and solid neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.