Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-20 @ 12:33 PM
Study NCT ID:
NCT01742793
Status:
TERMINATED
Last Update Posted:
2020-03-04
First Post:
2012-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study)
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
An Open Label, International, Multi-centre, Phase I/IIa Study of Lenalidomide (Revlimid) and Romidepsin (Istodax) for Relapsed /Refractory Hodgkin Lymphoma, Mature T-cell Lymphoma and Multiple Myeloma. (RId Study)
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to withdrawal of institutional support, Phase II never began.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RID
Brief Summary:
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.
Detailed Description:
Summary of rationale:
1. As individual agents, both the histone deacetylase inhibitors and lenalidomide have significant activity in each of the diseases in this study;
2. There is potential for the agents to synergize (to improve upon the response rates as there are both overlapping and disparate mechanisms of action.) Both agents may synergize to induce cell death through caspase 8-mediated and other mechanisms; both induce p21 and cell cycle arrest; both agents have anti-angiogenic effects; both are likely to interfere with PI3K/Akt signaling. One particularly attractive aspect of this combination is the potential for synergistic immunological effects, particularly related to T-cell polarization, NK cell activation, STAT signaling and cytokine production, as discussed above;
3. With respect to PTCL, CTCL and HL, there is a clear path for further drug development and registration if this trial proves that this is a safe and efficacious combination;
4. Myeloma is incurable and this is due to the persistence of a drug-resistant sub-clone of tumor-propagating cells that is drug insensitive. Preclinical data suggests that both HDACi and lenalidomide may target these tumor-propagating cells. This argues for examining this combination as part of early treatment in these diseases. This trial is the first step to examine the feasibility of combining an HDACi with what is front-line therapy in myeloma in the USA - lenalidomide.
5. Incorporating three separate arms (as opposed to three separate studies) will allow;
i. The investigators to accumulate data on this novel combination across the three groups and evaluate the toxicity profiles to make informed decisions around dose-escalation. Because it is a single study, valid comparisons can be made across the groups, which would not be possible if they were separate studies.
ii. combined and simplified collection of correlative tests across the three studies.
This study was terminated and Phase 2 portion never was initiated.
1. As individual agents, both the histone deacetylase inhibitors and lenalidomide have significant activity in each of the diseases in this study;
2. There is potential for the agents to synergize (to improve upon the response rates as there are both overlapping and disparate mechanisms of action.) Both agents may synergize to induce cell death through caspase 8-mediated and other mechanisms; both induce p21 and cell cycle arrest; both agents have anti-angiogenic effects; both are likely to interfere with PI3K/Akt signaling. One particularly attractive aspect of this combination is the potential for synergistic immunological effects, particularly related to T-cell polarization, NK cell activation, STAT signaling and cytokine production, as discussed above;
3. With respect to PTCL, CTCL and HL, there is a clear path for further drug development and registration if this trial proves that this is a safe and efficacious combination;
4. Myeloma is incurable and this is due to the persistence of a drug-resistant sub-clone of tumor-propagating cells that is drug insensitive. Preclinical data suggests that both HDACi and lenalidomide may target these tumor-propagating cells. This argues for examining this combination as part of early treatment in these diseases. This trial is the first step to examine the feasibility of combining an HDACi with what is front-line therapy in myeloma in the USA - lenalidomide.
5. Incorporating three separate arms (as opposed to three separate studies) will allow;
i. The investigators to accumulate data on this novel combination across the three groups and evaluate the toxicity profiles to make informed decisions around dose-escalation. Because it is a single study, valid comparisons can be made across the groups, which would not be possible if they were separate studies.
ii. combined and simplified collection of correlative tests across the three studies.
This study was terminated and Phase 2 portion never was initiated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 115541 | OTHER | FDA | View |