Cutaneous T-Cell LymphomaPhase 2NCT00699296
Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
A Phase 2 study testing Panobinostat (LBH589) in people with Cutaneous T-Cell Lymphoma and Leukemia-Lymphoma, Adult T-Cell, run by Novartis Pharmaceuticals at 7 sites in Japan.
Trial summary
This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma, Leukemia-Lymphoma, Adult T-Cell
- What is being tested?
- Panobinostat (LBH589)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesJapan
- Study dates
- May 2008to Dec 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CTCL: Biopsy-confirmed MF or SS stages IB-IVA2.
- Patients who have SS with bone marrow involvement are also eligible.
- Patients with transformed CTCL are eligible.
- ATL: Patient with cytologically or histopathologically confirmed lymphoma.
- Lymphoma should be identified as tumors derived peripheral T-cells by cell surface marker.
- ATL: Patients with positivity for anti-HTLV-1 antibody
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- Patients must have received at least two systemic therapy regimens.
- Patients must have had disease progression on or following their most recent treatment regimen.
- Age ≥ 20 years
- ECOG Performance Status of ≤ 2
- Written informed consent obtained prior to any study specific screening procedures
Who cannot join
- Patients with a history of primary CNS tumors
- Any history or presence of brain metastases
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Patients with unresolved diarrhea > CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Patients with concurrent severe and/or uncontrolled liver or renal disease
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- Patients using sodium valproate ≤5 days prior to starting study drug
- Patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin or other antivitamin K drugs
- Patients who have received any investigational drug or chemotherapy or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Patients who have received biologic therapy, target therapy (e.g. denileukin diftitix ), vaccine, systemic steroids or immunotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy
- Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
University Hospital of Occupational and Environmental Health
Fukuoka
Imamura Bun-in Hospital
Kagoshima
Kumamoto University Hospital
Kumamoto
University of Miyazaki Hospital
Miyazaki
Nagasaki University Hospital of Medicine and Dentistry
Nagasaki
Okayama University Hospital
Okayama
The University of Tokyo Hospital
Tokyo
About this study
Official title: A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.
- Being tested
- Panobinostat (LBH589)
- Keywords
- LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Leukemia-Lymphoma, Adult T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panobinostat (LBH589)Drug
Also called LBH589
20mg/day p.o. on three times-a- week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Panobinostat (LBH589) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow
Measured: Every Cycle
Secondary outcomes (1)
Response rate using mSWAT Response rate using the Physician's Global Assessment of Clinical Condition (PGA) Responses in index lesions by skin lesion measurements and with photographic supporting documentation Overall response(CR/PR) rate by using PG
Measured: 1 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Makoto Sugaya, Principal investigator, The University of Tokyo HospitalKenji Iwatsuki, Principal investigator, Okayama UniversityYoshiki Tokura, Principal investigator, University Hospital of Occupational and Environmental HealthKunihiro Tsukasaki, Principal investigator, Nagasaki University Hospital of Medicine and DentistryHironobu In, Principal investigator, Kumamoto University HospitalMitsuru Setoyama, Principal investigator, University of Miyazaki HospitalAtae Utsunomiya, Principal investigator, Imamura Bun-in Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699296
- Sponsor's protocol ID
- CLBH589B1201
- Status last verified
- Nov 2012
- First submitted
- 13 Jun 2008
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT00699296
- Acronym / sponsor ID
- CLBH589B1201
- Keywords
- LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- First posted
- 17 Jun 2008 (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.
This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Panobinostat (LBH589) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- CTCL: Biopsy-confirmed MF or SS stages IB-IVA2.
- Patients who have SS with bone marrow involvement are also eligible.
- Patients with transformed CTCL are eligible.
- ATL: Patient with cytologically or histopathologically confirmed lymphoma.
- Lymphoma should be identified as tumors derived peripheral T-cells by cell surface marker.
Key exclusion criteria (11 listed)
- Patients with a history of primary CNS tumors
- Any history or presence of brain metastases
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Patients with unresolved diarrhea > CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
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 |
|---|---|---|
| Panobinostat (LBH589)Also: LBH58920mg/day p.o. on three times-a- week | Drug | 1 |
Primary outcome
Overall response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow
Time frame: Every Cycle
1 secondary outcome
Response rate using mSWAT Response rate using the Physician's Global Assessment of Clinical Condition (PGA) Responses in index lesions by skin lesion measurements and with photographic supporting documentation Overall response(CR/PR) rate by using PG
Time frame: 1 cycle
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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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.
Makoto Sugaya principal investigator
The University of Tokyo Hospital
Kenji Iwatsuki principal investigator
Okayama University
Yoshiki Tokura principal investigator
University Hospital of Occupational and Environmental Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panobinostat (LBH589) in people with Cutaneous T-Cell Lymphoma and Leukemia-Lymphoma, Adult T-Cell, run by Novartis Pharmaceuticals at 7 sites in Japan.
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 11 inclusion and 11 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 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. 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 response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow (time frame: Every Cycle). 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 27 Nov 2012.