Hodgkin's LymphomaPhase 3PATHNCT01034163
A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL)
A Phase 3 study testing Panobinostat in people with Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 35 sites in 14 countries.
Trial summary
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Panobinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 35 sitesin 14 countries
- Study dates
- Jun 2010to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient age is greater than or equal to 18 years
- Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
- Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:
- Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.
- Patient has at least one of the following factors that places them at risk for relapse:
- Primary refractory disease (including relapse in ≤ 3 months of completion of 1st line treatment)
Show all 10Show fewer
- First relapse >3 but <12 months from last dose of 1st line treatment
- Multiple relapses (prior to transplant)
- Stage III/IV disease (at relapse, prior to transplant)
- Hemoglobin <10.5 gm/dL (at relapse, prior to transplant)
Who cannot join
- Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:
- chemotherapy prior to start of study
- biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
- radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat
Trial locations and contacts
35 sites in 14 countries.
35 sites in 14 countries
United States13 sites
Georgia Health Sciences University Medical College of Georgia
Augusta, Georgia, 30912
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Medical University of South Carolina Oncology
Charleston, South Carolina, 29425
Northwestern University Oncology
Chicago, Illinois, 60611-3308
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46202
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of California at Los Angeles
Los Angeles, California, 90095
Medical College of Wisconsin Oncology
Milwaukee, Wisconsin, 53226
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506-9162
Vanderbilt University Medical Center Vanderbilt Clinic - Oncology
Nashville, Tennessee, 37232
Mayo Clinic - Rochester Hematology/Oncology Dept.
Rochester, Minnesota, 55905
France3 sites
Novartis Investigative Site
Caen, Cedex, 14033
Novartis Investigative Site
Dijon, 21079
Novartis Investigative Site
Lille, France, 59 037
Germany3 sites
Novartis Investigative Site
Cologne, 50937
Novartis Investigative Site
Duisburg, 47166
Novartis Investigative Site
Essen-Werden, 45239
Brazil2 sites
Novartis Investigative Site
Curitiba, Paraná, 81520-060
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Israel2 sites
Novartis Investigative Site
Haifa, 3525408
Novartis Investigative Site
Ramat Gan, 5266202
Netherlands2 sites
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Rotterdam, 3075 EA
Poland2 sites
Novartis Investigative Site
Krakow, 30-510
Novartis Investigative Site
Wroclaw, 50-367
Russia2 sites
Novartis Investigative Site
ChelyabinskChemo, 620102
Novartis Investigative Site
Saint Petersburg, 197022
About this study
Official title: A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Panobinostat, Placebo
- Keywords
- Phase III randomized, double blind, placebo controlled multi-center study, panobinostat, Hodgkin's lymphoma, at risk for relapse, autologous stem cell transplant
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanobinostatDrug
Also called LBH589
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Panobinostat (PAN) | Experimental | Participants received 45 mg orally 3 times a week (TIW), every other week (QOW), Receives: Drug: Panobinostat |
| Placebo | Placebo comparator | Participants received matching placebo to PAN TIW, QOW. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Safety monitoring was conducted throughout the study.
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034163
- Sponsor's protocol ID
- CLBH589E2301
- Other IDs
- 2009-014846-26, 2009
- Acronym
- PATH
- Status last verified
- May 2016
- First submitted
- 15 Dec 2009
- Last updated
- 7 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)
- ClinicalTrials.gov ID
- NCT01034163
- Acronym / sponsor ID
- PATH / CLBH589E2301
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Phase III randomized, double blind, placebo controlled multi-center study, panobinostat, Hodgkin's lymphoma, at risk for relapse, autologous stem cell transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 7 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panobinostat (PAN) | Experimental | Drug: PanobinostatParticipants received 45 mg orally 3 times a week (TIW), every other week (QOW), |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo to PAN TIW, QOW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient age is greater than or equal to 18 years
- Patient has a history of histologically confirmed classical HL (i.e. Nodular sclerosing (NSHL), Mixed-cellularity (MCHL), Lymphocyte-rich (LRHL), Lymphocyte depleted (LDHL))
- Patient has achieved a complete response by CT/MRI scan within 9 weeks (± 1 week) from the day of their first autologous peripheral blood/ bone marrow stem cell transfusion (AHSCT) following HDT. Complete response is defined as:
- Normalization of all nodes and lesions compared to pre-transplant scan performed prior to salvage therapy for relapse. Any residual abnormal masses on the post transplant CT/MRI must be metabolically inactive on a PET scan.
- Patient has at least one of the following factors that places them at risk for relapse:
Key exclusion criteria (4 listed)
- Patient has been treated with allogeneic transplant 2. Patient has received any anti-lymphoma therapy after AHSCT including but not limited to:
- chemotherapy prior to start of study
- biologic immunotherapy including monoclonal antibodies or experimental therapy prior to start of study
- radiation therapy 3. Patient has not recovered from reversible toxicity due to any prior therapies (e.g. returned to baseline or Grade ≤1) except for hematological laboratory parameters Note: Patient does not meet this criteria if the toxicity is stable and irreversible, and there is no evidence that panobinostat causes a similar toxicity 4. Patient has received prior treatment with DAC inhibitors including panobinostat
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 |
|---|---|---|
| PanobinostatAlso: LBH589 | Drug | Panobinostat (PAN) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 23 months
Safety monitoring was conducted throughout the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
35 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Panobinostat in people with Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 35 sites in 14 countries.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, France, Germany, Brazil, Israel and 9 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (time frame: 23 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 7 Jul 2016.