Hodgkin's LymphomaPhase 1RIDNCT01742793
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)
A Phase 1 study testing lenalidomide (Revlimid) and romidepsin (Istodax) in people with Hodgkin's Lymphoma and Mature T-cell Lymphoma, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hodgkin's Lymphoma, Mature T-cell Lymphoma, Multiple Myeloma
- What is being tested?
- lenalidomide (Revlimid) and romidepsin (Istodax)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have a biopsy-proven diagnosis of one of the following malignancies that meets the additional disease-specific inclusion criteria.
- Mature T-Cell lymphoma. The following entities are eligible. PTCL or CTCL (including MF and SS) but excluding adult T-cell leukemia/lymphoma, primary cutaneous CD30+ lymphoma, lymphomatoid papulosis, and NK or LGL leukemia.(The complete WHO classification of T-cell lymphoma can be found in the appendices).
- Peripheral T-cell lymphoma: patients must have relapsed or progressed after: at least one prior chemotherapy-based treatment, or not suitable for a conventional chemotherapeutic approach as judged by the investigator.
- Sezary syndrome/ Mycosis Fungoides: patients must have relapsed or progressed after at least one prior systemic therapy.
- Hodgkin lymphoma
- At least one prior chemotherapy-based treatment.
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- Prior autograft in those eligible for autologous transplantation according to institutional guidelines.
- Myeloma
- Relapsed after at least one prior systemic therapy that includes thalidomide (unless intolerant or contraindicated) or lenalidomide. Those who have received prior lenalidomide must have had a response that exceeded 6 months.
- Patients who are candidates for autologous stem cell transplant in first remission are not eligible.
- Patients must have failed/relapsed after bortezomib therapy.
- ECOG performance status <2
- Age >18 years.
- Life expectancy ≥90 days.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count >1.0 x109/L (or greater than 0.75x109/L if >50% plasma cells or >50% lymphoma in the bone marrow) Neutrophil count must not be supported by G-CSF prior to study entry. platelets >100 x109/L (or >75 x 109 if >50% plasma cells or >50% lymphoma in the bone marrow).
- (Transfusion to achieve these goals would not qualify the patient) total bilirubin <1.5x the institutional upper limit of normal. (<2.5x for Gilbert's disease).
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- Creatinine clearance >60 mL/min/1.73 m2 in the dose escalation phase, and >30 mL/min/1.73 m2 in phase II.
- Serum potassium \& magnesium Serum potassium ≥3.8 mmol/L Serum magnesium ≥1.8mg/dL /0.75mmol/L (supplementation is allowed)
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
Who cannot join
- Patients receiving any other investigational agents within 4 weeks.
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not adequately recovered from grade III/IV adverse events due to agents administered more than 4 weeks earlier.
- Prior exposure to lenalidomide, in patients with myeloma, except if a response (including stable disease) was maintained for at least 6 months. (Washout period of 4 weeks required)
- Prior treatment with HDAC inhibitor (not including sodium valproate for neurological or psychiatric disorders), except if response (including stable disease) was maintained for at least 3 months. (Washout period of 4 weeks required)
- Concomitant treatment with sodium valproate (washout 4 weeks required).
- Central nervous system involvement by lymphoma or myeloma.
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- A history of allergic reaction to romidepsin or lenalidomide, boron or mannitol.
- A history of Gr III/IV drug-related non-hematological toxicity, excluding thromboembolism or sepsis, in a prior exposure to either lenalidomide or a histone deacetylase inhibitor.
- Concomitant corticosteroid except for patients on a stable dose of ≤10mg prednisone/day for at least 4 weeks prior to screening.
- Congenital long QT syndrome, or a QTc interval >450 milliseconds
- Patients who have had a myocardial infarction within twelve months of study entry.
- Patients who have active coronary artery disease (for example NYHA class II or above angina).
- Any patient in whom coronary artery disease is suspected should be referred for a cardiology consultation and if active myocardial ischemia is demonstrated, the patient should be excluded. If a non-invasive imaging study is equivocal, it may be necessary to proceed to coronary angiography.
- Patients with a baseline ECG showing evidence of cardiac ischaemia (ST depression of ≥2mm)
- Patients with NYHA-class congestive heart failure ≥II
- Patients with cardiac ejection fraction less than the institutional lower limited of normal by a gated heart-pool scan, or echocardiogram.
- Patients with a history of sustained VT, VF, torsade de pointes or cardiac arrest unless that issue is currently managed with an implantable cardioverter defibrillator (AICD).
- Patients with a cardiomyopathy of any cause.
- Patients with uncontrolled hypertension ie. SBP ≥160mmHg or DBP ≥95mmHg
- Patients with cardiac arrythmia requiring anti-arrythmic medication other than a beta blocker or calcium channel blocker. Patients in who digitalis can not be discontinued are excluded from the study.
- Patients with mobitz-II second degree heart block that do not have a pacemaker.
- Patients with first degree or Mobitz-I second degree block, bradyarrhythmia or sick sinus syndrome require holter monitoring and evaluation for eligibility by a cardiologist.
- Patients with other cardiac disease may be excluded at the discretion of the PI following consultation with a cardiologist.
- Patients who require concomitant use of drugs known to cause significant prolongation of the QT interval.
- Patients who require concomitant use of warfarin, due to potential for drug interaction.
- Pregnancy in female patients. Lactating females must agree not to breast feed while taking lenalidomide.
- Patients with known HIV infection.
- Patients with known Hepatitis B infection.
- Prior allotransplantation, unless the patient has been completely weaned off immunosuppressive agents for ≥3 months.
- Myeloma, patient who is a candidate for autologous stem cell transplant
- Pre-existing motor or sensory neuropathy ≥ grade 3.
- Other serious and / or uncontrolled medication condition
- Prior diagnosis of cancer that was:
- more than 3 years prior to current diagnosis with estimated clinical expectation of progression greater than 10% within next 2 years.
- within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix or localised cancer treated curatively with local therapy only.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Summary of rationale:
- As individual agents, both the histone deacetylase inhibitors and lenalidomide have significant activity in each of the diseases in this study;
- 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;
- 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;
- 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.
- Incorporating three separate arms (as opposed to three separate studies) will allow;
- 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.
- Conditions
- Hodgkin's Lymphoma, Mature T-cell Lymphoma, Multiple Myeloma
- Being tested
- lenalidomide (Revlimid) and romidepsin (Istodax)
- Keywords
- relapsed /refractory Hodgkin lymphoma, mature T-cell lymphoma, multiple myeloma
- Medical subject headings
- Hodgkin Disease, Lymphoma, T-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomide (Revlimid) and romidepsin (Istodax)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm L: subjects with lymphoma | Experimental | 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. Receives: Drug: lenalidomide (Revlimid) and romidepsin (Istodax) |
| Arm M: subjects with myeloma | Experimental | 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. Receives: Drug: lenalidomide (Revlimid) and romidepsin (Istodax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (1)
Rate of Overall survival (OS)
Measured: From date of randomization until the date of death from any cause, assessed up to 70 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: The study was terminated due to withdrawal of institutional support, Phase II never began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Responsible party
- Principal investigator, Francine Foss, Yale University
- Investigators
- Francine Foss, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742793
- Sponsor's protocol ID
- 1112009392
- Other IDs
- 115541
- Acronym
- RID
- Status last verified
- Feb 2017
- First submitted
- 21 Nov 2012
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01742793
- Acronym / sponsor ID
- RID / 1112009392
- Conditions
- Hodgkin's Lymphoma, Mature T-cell Lymphoma, Multiple Myeloma
- Keywords
- relapsed /refractory Hodgkin lymphoma, mature T-cell lymphoma, multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to withdrawal of institutional support, Phase II never began.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- As individual agents, both the histone deacetylase inhibitors and lenalidomide have significant activity in each of the diseases in this study;
- 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;
- 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;
- 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.
- Incorporating three separate arms (as opposed to three separate studies) will allow;
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm L: subjects with lymphoma | Experimental | Drug: lenalidomide (Revlimid) and romidepsin (Istodax)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. |
| Arm M: subjects with myeloma | Experimental | Drug: lenalidomide (Revlimid) and romidepsin (Istodax)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- All patients must have a biopsy-proven diagnosis of one of the following malignancies that meets the additional disease-specific inclusion criteria.
- ECOG performance status <2
- Age >18 years.
- Life expectancy ≥90 days.
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (35 listed)
- Patients receiving any other investigational agents within 4 weeks.
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not adequately recovered from grade III/IV adverse events due to agents administered more than 4 weeks earlier.
- Prior exposure to lenalidomide, in patients with myeloma, except if a response (including stable disease) was maintained for at least 6 months. (Washout period of 4 weeks required)
- Prior treatment with HDAC inhibitor (not including sodium valproate for neurological or psychiatric disorders), except if response (including stable disease) was maintained for at least 3 months. (Washout period of 4 weeks required)
- Concomitant treatment with sodium valproate (washout 4 weeks required).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomide (Revlimid) and romidepsin (Istodax) | Drug | Arm L: subjects with lymphoma, Arm M: subjects with myeloma |
Primary outcome
Overall Rate of Clinical Response (Complete Response + Partial Response)
Time frame: 12 months
Overall response rate is a combination of partial response and complete response according to specific response criteria that will be used throughout the study.
Overall Rate of Clinical Response (Complete Response + Partial Response)
Time frame: 24 months
Overall response rate is a combination of partial response and complete response according to specific response criteria that will be used throughout the study.
1 secondary outcome
Rate of Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 70 months.
Results and safety
The study was stopped early (reason given: The study was terminated due to withdrawal of institutional support, Phase II never began.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Yale Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francine Foss, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenalidomide (Revlimid) and romidepsin (Istodax) in people with Hodgkin's Lymphoma and Mature T-cell Lymphoma, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to withdrawal of institutional support, Phase II never began.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Rate of Clinical Response (Complete Response + Partial Response) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.