NCT01742793|TerminatedPhase 1DMC
Study Stopped
The study was terminated due to withdrawal of institutional support, Phase II never began.
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The study was terminated due to withdrawal of institutional support, Phase II never began.
RID
Sponsor study identifier
Secondary identifiers
OTHER · FDA
interventional
12
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study Completion
August 2016
Actual (reported)The study hypothesis is that lenalidomide and romidepsin (and dexamethasone for patients with myeloma) will have an acceptable toxicity profile and that in combination will have sufficient activity in the target population (including those previously refractory to HDACi monotherapy) to warrant further investigation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 21, 2012
Actual (reported)December 5, 2012
Actual (reported)August 2016
Actual (reported)August 2016
Actual (reported)Overall Rate of Clinical Response (Complete Response + Partial Response)
Overall response rate is a combination of partial response and complete response according to specific response criteria that will be used throughout the study.
12 months
Overall Rate of Clinical Response (Complete Response + Partial Response)
Overall response rate is a combination of partial response and complete response according to specific response criteria that will be used throughout the study.
24 months
Rate of Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to 70 months.
The following dosing steps will be applied to the dose-escalation, phase-I component of the study for patients with lymphoma who are eligible to enter Arm L: Dose Level Arm L Lenalidomide dose Oral Romidepsin Dose Intravenous * 2 10mg D1-7, D15-21 6mg D1, 8, 15 * 1 10mg D1-7, D15-21 8mg D1, 8, 15 1. 10mg D1-21 8mg D1, 8, 15 2 15mg D1-21 8mg D1, 8, 15 3 15mg D1-21 10mg D1, 8, 15 4 15mg D1-21 12mg D1, 8, 15 5 15mg D1-21 14mg D1, 8, 15 6 25mg D1-21 14mg D1, 8, 15 * The first patient in arm L will be entered into the study at dosing level one.
The following dosing steps will be applied to the dose-escalation, phase-I component of the study for patients with myeloma who are eligible to enter Arm M: Dose Level Arm M Lenalidomide dose Oral Romidepsin Dose Intravenous Dexamethasone * 2 15mg D1-7, D15-21 6mg D1, 8, 15 20mg D1,8,15,22 * 1 15mg D1-7, D15-21 8mg D1, D8, 15 20mg D1,8,15,22 1. 15mg D1-21 8mg D1, 8, 15 20mg D1,8,15,22 2 25mg D1-21 8mg D1, 8, 15 20mg D1,8,15,22 3 25mg D1-21 10mg D1, 8, 15 20mg D1,8,15,22 4 25mg D1-21 12mg D1, 8, 15 20mg D1,8,15,22 5 25mg D1-21 14mg D1, 8, 15 20mg D1,8,15,22 * The first patient in arm M will be entered into the study at dosing level one.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
lenalidomide (Revlimid) and romidepsin (Istodax)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordYale Cancer Center
New Haven, Connecticut, 06519, United States
Francine Foss, MD
Yale University
12 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2012
First Posted
December 5, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2016
Actual (reported)Study Completion
August 2016
Actual (reported)Last Updated
March 4, 2020
Record last verified: 2017-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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