Peripheral T Cell Lymphoma (PTCL)Phase 2NCT00299351
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.
A Phase 2 study testing Depsipeptide in people with Peripheral T Cell Lymphoma (PTCL), run by Royal Marsden NHS Foundation Trust.
Trial summary
To evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide clinical trials, and in the opinion of their physician/ investigator might benefit from continued treatment with depsipeptide Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma (PTCL)
- What is being tested?
- Depsipeptide
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent/ authorization Patient has completed 6 cycles of therapy in a prior Gloucester-sponsored depsipeptide clinical trial Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Gloucester-sponsored depsipeptide clinical trial Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Gloucester-sponsored depsipeptide clinical trial and such response must be ongoing at the time of enrollment Patient must have serum potassium levels >4.0mEq/L and serum magnesium levels >2.0mg/dL Negative urine or serum pregnancy test on females of childbearing potential Sexually active females of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy after entering the trial Sexually active males must be willing to practice reliable methods of birht control after entering the trial
Who cannot join
- Patients wiht known cardiac abnormalities such as
- congenital long QT syndrome
- QTc interval >480 milliseconds Patients with any cardiac arrhythmia requiring anti-arrhythmic medication Patients who have had a history of coronary artery disease (CAD) eg. angina Canadian class II-IV (see appendix G)> In any patient whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiopathy to define whether or not CAD is present Patients who have had a myocardial infarction within 12 months of study entry. Patients with an ECG recorded at screening showing evidence of cardiac ishemia (ST depression of >2mm). If in any doubt, the patient should have a stress imaging study and if abnormal, angiograpphy to define whether or not CAD is present Patients with congestive heart failure that meets New York heart Association (NYHA) Class II to IV (see appendix F) definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI) Patients with a history of sustained VT,VF,Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD) Patients with a hypertrophic cardiomelagy or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above) Patients with uncontrolled hypertension ie > 160/95 Concomitant use of medications which may cause a prolongation of QT/QTc Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 Absolute neutrophil count (ANC) < 1.5 X 109 cells/L Platelet count <75 x 109 cells/L Serum creatinine concentration >2 mg/dL or creatinine clearance <40mL/min AST (aspartate aminotransferase ) and alanine aminotransferase (ALT) >2.0 x ULN or >5 X ULN in presence of demonstable liver metastasis Bilirubin concentration > 1.25 x ULN or > 2.0 x ULN in presence of demonstrable liver metastases Serum potassium <4.0mEq/L and serum magnesium <2.0 mg/dL Failure to recover of any drug-related non-hematological toxicity to grade 1 oe less or to baseline values unless otherwise indicated Concomitant use of warfarin (due to a potentialdrug to drug interaction with depsipeptide) Patient is pregnant or nursing Patient had been on prior Gloucester-sponsored depsipeptide clinical trial, left the trial and then received alternative neoplastic therapy
About this study
To evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide clinical trials, and in the opinion of their physician/ investigator might benefit from continued treatment with depsipeptide
- Conditions
- Peripheral T Cell Lymphoma (PTCL)
- Being tested
- Depsipeptide
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepsipeptideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell Lymphoma (PTCL)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Dr Johann De Bono, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299351
- Sponsor's protocol ID
- CCR2742
- Status last verified
- Nov 2005
- First submitted
- 3 Mar 2006
- Last updated
- 6 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.
- ClinicalTrials.gov ID
- NCT00299351
- Acronym / sponsor ID
- CCR2742
- Conditions
- Peripheral T Cell Lymphoma (PTCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- First posted
- 6 Mar 2006 (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.
To evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide clinical trials, and in the opinion of their physician/ investigator might benefit from continued treatment with depsipeptide
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent/ authorization Patient has completed 6 cycles of therapy in a prior Gloucester-sponsored depsipeptide clinical trial Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Gloucester-sponsored depsipeptide clinical trial Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Gloucester-sponsored depsipeptide clinical trial and such response must be ongoing at the time of enrollment Patient must have serum potassium levels >4.0mEq/L and serum magnesium levels >2.0mg/dL Negative urine or serum pregnancy test on females of childbearing potential Sexually active females of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy after entering the trial Sexually active males must be willing to practice reliable methods of birht control after entering the trial
Key exclusion criteria (3 listed)
- Patients wiht known cardiac abnormalities such as
- congenital long QT syndrome
- QTc interval >480 milliseconds Patients with any cardiac arrhythmia requiring anti-arrhythmic medication Patients who have had a history of coronary artery disease (CAD) eg. angina Canadian class II-IV (see appendix G)> In any patient whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiopathy to define whether or not CAD is present Patients who have had a myocardial infarction within 12 months of study entry. Patients with an ECG recorded at screening showing evidence of cardiac ishemia (ST depression of >2mm). If in any doubt, the patient should have a stress imaging study and if abnormal, angiograpphy to define whether or not CAD is present Patients with congestive heart failure that meets New York heart Association (NYHA) Class II to IV (see appendix F) definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI) Patients with a history of sustained VT,VF,Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD) Patients with a hypertrophic cardiomelagy or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above) Patients with uncontrolled hypertension ie > 160/95 Concomitant use of medications which may cause a prolongation of QT/QTc Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 Absolute neutrophil count (ANC) < 1.5 X 109 cells/L Platelet count <75 x 109 cells/L Serum creatinine concentration >2 mg/dL or creatinine clearance <40mL/min AST (aspartate aminotransferase ) and alanine aminotransferase (ALT) >2.0 x ULN or >5 X ULN in presence of demonstable liver metastasis Bilirubin concentration > 1.25 x ULN or > 2.0 x ULN in presence of demonstrable liver metastases Serum potassium <4.0mEq/L and serum magnesium <2.0 mg/dL Failure to recover of any drug-related non-hematological toxicity to grade 1 oe less or to baseline values unless otherwise indicated Concomitant use of warfarin (due to a potentialdrug to drug interaction with depsipeptide) Patient is pregnant or nursing Patient had been on prior Gloucester-sponsored depsipeptide clinical trial, left the trial and then received alternative neoplastic therapy
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 |
|---|---|---|
| Depsipeptide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2006.
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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.
Dr Johann De Bono principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Depsipeptide in people with Peripheral T Cell Lymphoma (PTCL), run by Royal Marsden NHS Foundation Trust.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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.
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 6 Mar 2006.