Peripheral T-Cell Non-Hodgkin's LymphomaPhase 1/2LenVoDexNCT00972842
Lenalidomide, Vorinostat and Dexamethasone in Relapsed Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
A Phase 1/2 study testing Vorinostat, Lenalidomide in people with Peripheral T-Cell Non-Hodgkin's Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 5 sites in Austria.
Trial summary
A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Non-Hodgkin's Lymphoma
- What is being tested?
- Vorinostat, Lenalidomide
- How many people
- 20 participants
- Where
- 5 sitesAustria
- Study dates
- Sep 2009to Jul 2012
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL
- Age ≥ 18 years.
- Adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
- Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
- Total bilirubin ≤ 2,5 x ULN
- Creatinine clearance ≥ 50 ml/min
- Female subjects of childbearing potential† must: Understand that the study medication could have an expected teratogenic risk and agree to use, and be able to comply with, effective contraception and agree to have a medically supervised pregnancy test
- Male subjects must agree to use condoms and agree not to donate semen
Who cannot join
- Prior history of malignancies, other than PTCL, unless the subject has been free of the disease for ≥ 3 years
- Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
- Prior treatment with a HDAC inhibitor
- Prior treatment with Lenalidomide (patients previously treated with Thalidomide may be enrolled)
- Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, A-6020
Krankenhaus der Elisabethinen Linz
Linz, A-4010
Krankenhaus der Stadt Linz
Linz, A-4020
Universitaetsklinik f. Innere Medizin III
Salzburg, A-5020
Hanusch Krankenhaus
Vienna, A-1140
About this study
Official title: Phase I/II Trial of Lenalidomide in Combination With Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens.
The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.
- Conditions
- Peripheral T-Cell Non-Hodgkin's Lymphoma
- Being tested
- Vorinostat, Lenalidomide
- Keywords
- PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorinostat, LenalidomideDrug
Also called Revlimid®, Zolinza®
Lenalidomide: Dose escalation 10 /15 /20 /25mg/d d1-21 q28d; for 6 treatment cycles
Vorinostat: 400 mg d1-21 q28d, for 6 treatment cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.
Measured: 6 months
Secondary outcomes (1)
Remission rate of a combination therapy with Lenalidomide, Vorinostat, and Dexamethasone in a treatment refractory or relapsed population, defined as the percentage of patients achieving a complete response (CR) or partial response (PR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-Cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Georg Hopfinger, MD, Principal investigator, Hanusch Krankenhaus Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972842
- Sponsor's protocol ID
- AGMT_PTCL1
- Other IDs
- EudraCT 2008-006919-20
- Acronym
- LenVoDex
- Status last verified
- Dec 2013
- First submitted
- 7 Sep 2009
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Lenalidomide in Combination With Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT00972842
- Acronym / sponsor ID
- LenVoDex / AGMT_PTCL1
- Conditions
- Peripheral T-Cell Non-Hodgkin's Lymphoma
- Keywords
- PTCL, Peripheral T-Cell Non-Hodgkin's Lymphoma, Vorinostat, Lenalidomid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Celgene Corporation
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Sep 2009 (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.
A standard therapy is neither established in first-line patients nor in relapsed patients with PTCL, and there is still an unmet medical need to identify novel efficacious and safe therapy regimens.
The aim of this study is to evaluate the potential of a Lenalidomide plus Vorinostat and Dexamethasone combination therapy as an effective and safe therapeutic regimen, in the treatment of relapsed PTCL following failure of prior regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with relapsed PTCL according to WHO criteria who have received max. two previous treatments for PTCL
- Age ≥ 18 years.
- Adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and thrombocytes > 75,000/µl.
- Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
- Total bilirubin ≤ 2,5 x ULN
Key exclusion criteria (5 listed)
- Prior history of malignancies, other than PTCL, unless the subject has been free of the disease for ≥ 3 years
- Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic bone marrow transplant within 4 weeks of the initiation of vorinostat administration
- Prior treatment with a HDAC inhibitor
- Prior treatment with Lenalidomide (patients previously treated with Thalidomide may be enrolled)
- Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)
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 |
|---|---|---|
| Vorinostat, LenalidomideAlso: Revlimid®, Zolinza®Lenalidomide: Dose escalation 10 /15 /20 /25mg/d d1-21 q28d; for 6 treatment cycles Vorinostat: 400 mg d1-21 q28d, for 6 treatment cycles | Drug | – |
Primary outcome
The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.
Time frame: 6 months
1 secondary outcome
Remission rate of a combination therapy with Lenalidomide, Vorinostat, and Dexamethasone in a treatment refractory or relapsed population, defined as the percentage of patients achieving a complete response (CR) or partial response (PR)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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.
Georg Hopfinger, MD principal investigator
Hanusch Krankenhaus Wien
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vorinostat, Lenalidomide in people with Peripheral T-Cell Non-Hodgkin's Lymphoma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 5 sites in Austria.
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 8 inclusion and 5 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: slow recruitment). 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?
The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level. (time frame: 6 months). 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 24 Dec 2013.