A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma (HL) (PATH)
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| ClinicalTrials.gov Identifier: NCT01034163 |
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Recruitment Status :
Completed
First Posted : December 17, 2009
Results First Posted : July 7, 2016
Last Update Posted : July 7, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hodgkin's Lymphoma | Drug: Panobinostat Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Panobinostat (PAN)
Participants received 45 mg orally 3 times a week (TIW), every other week (QOW),
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Drug: Panobinostat
Other Name: LBH589 |
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Placebo Comparator: Placebo
Participants received matching placebo to PAN TIW, QOW.
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Drug: Placebo
Placebo |
- Number of Participants With Adverse Events [ Time Frame: 23 months ]Safety monitoring was conducted throughout the study.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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))
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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.
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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)
- 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)
Exclusion Criteria:
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034163
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01034163 |
| Other Study ID Numbers: |
CLBH589E2301 2009-014846-26 |
| First Posted: | December 17, 2009 Key Record Dates |
| Results First Posted: | July 7, 2016 |
| Last Update Posted: | July 7, 2016 |
| Last Verified: | May 2016 |
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Phase III randomized double blind placebo controlled multi-center study panobinostat |
Hodgkin's lymphoma at risk for relapse autologous stem cell transplant |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Panobinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |