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A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

ABSTRACT: This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

DISEASE(S): Peripheral T-cell Lymphomas Nec,T-cell Lymphoma Stage Iii,T-cell Lymphoma Stage Iv,T-cell Lymphoma Stage Ii,Adult T-cell Lymphomas/leukaemias,Intestinal T-cell Lymphomas,Lymphoma,Rollover Study Supporting All Indications From Prior Romidepsin Protocols Eligible For Participation In This Study.estudio De Extensión Que Recoge Todas Las Indicaciones De Protocolos Anteriores D...,T-cell Unclassifiable Lymphomas,Rollover Study Supporting All Indications From Prior Romidepsin Protocols Eligible For Participation In This Study.estudio De Extensión Que Recoge Todas Las Indicaciones De Protocolos Anteriores De Romidepsina Elegibles Para Participación En Este Estudio.,T-cell Lymphoma Stage I,T-cell Lymphoma Refractory,T-cell Lymphoma Recurrent,T-cell Lymphoma,Angioimmunoblastic T-cell Lymphomas,Cancer

PROVIDER: 2106666 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Terminalia arjuna (Roxb.) Wight & Arn., a well known Traditional medicine an. popularly known as Arjuna, has a long antiquity of its role as a cardiac stimulant, and has been stipulated in the treatment of hypercholesterolemia, heart failure and atherosclerosis. The present study was carried out to access the effects of Terminalia arjuna as an adjuvant therapy in angiographically proven patients with stable coronary artery disease who were on conventional medications. The goal of the study was to establish whether Terminalia arjuna exerts beneficial effects in targetting disease signatures which remain unresponsive to the standard therapies currently employed in the clinics. The present study scientifically validates the therapeutic effects of this medicinal plant as an adjuvant therapy along with conventional drugs routinely used in the clinics for prevention and treatment of coronary artery disease. To access the effect of T.arjuna, a placebo-controlled, double blind randomized study was carried out in 100 angiographically proven non-diabetic patients with coronary artery disease having disease more than 3 months prior to their enrollment and using any combination of cardiac-related medications including ASA, ACEIs, ARBs, β-blockers and statins (Trial Registration Number : REF/2013/03/004810). Out of total 100 patients, 50 patients were on drug A and 50 patients were on drug B for a total duration of 6 months (Follow-up at 3 and 6 months). Both Drug as well as placebo was given in the form of capsule (500mg) provided by The Himalaya Drug Company, Bangalore. Method of concealment was through coded identical containers. All the participants, investigator, outcome Assessor and data-entry operator were blinded during the whole study. Micro-array was performed in 2 randomly selected patients in each sub-group i.e. Terminalia arjuna or Placebo at 3 and 6 months respectively. RNA extraction and hybridization was carried out using Affymetrix microarrays. Differential expression of genes in T.arjuna-treated and Placebo groups was studied to understand the specificity, efficacy and mechanism of action of T.arjuna.

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A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

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