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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00742027 |
Purpose
This study will evaluate the efficacy of oral panobinostat in patients with refractory/relapsed classical HL who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat will also be assessed. Other markers that may correlate with efficacy or safety will be explored.
| Condition | Intervention | Phase |
|---|---|---|
|
Classical Hodgkin's Lymphoma (i.e. Nodular Sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte-depleted) |
Drug: Panobinostat |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma After High-dose Chemotherapy With Autologous Stem Cell. |
| Estimated Enrollment: | 102 |
| Study Start Date: | August 2008 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panobinostat |
Drug: Panobinostat
Oral 40 mg/dose, three times per week, every week dosing on a 21-day cycle
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has progressive disease after receiving high dose chemotherapy with AHSCT Note: If last therapy was ≥ 18 months ago, then biopsy should be performed to confirm diagnosis.
Note: Patient should have received ≤5 prior systemic treatment regimens (See Post-text supplement 2 for definitions and examples) Note: Patients will be allowed on study who have also received an allogeneic hematopoietic stem cell transplant, however this therapy alone is not sufficient for inclusion into this study.
Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan can not be performed).
Note: Patients with bone marrow involvement are eligible, but this criteria alone should not be used for disease measurement
Patient has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):
Exclusion Criteria:
Patient has impaired cardiac function including any of the following:
Male patient whose sexual partner(s) are WOCBP who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.
Patients with any of the following contraindications to PET are excluded from the [18F]-FDG PET study (only applicable for centers participating in the PET study):
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Show 65 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00742027 History of Changes |
| Other Study ID Numbers: | CLBH589E2214 |
| Study First Received: | August 25, 2008 |
| Last Updated: | March 16, 2011 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Egypt: Ministry of Health, Drug Policy and Planning Center; France: Afssaps - French Health Products Safety Agency; Germany: Ministry of Health; Israel: Ministry of Health; Italy: The Italian Medicines Agency; Malaysia: Ministry of Health; New Zealand: Medsafe; Singapore: Health Sciences Authority; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Classical Hodgkin Lymphoma Classical Hodgkin's Lymphoma Hodgkin Lymphoma Hodgkin's Lymphoma Nodular sclerosing Mixed-cellularity Lymphocyte-rich |
Lymphocyte depleted HL Classical HL Refractory Hodgkin's Lymphoma Refractory Hodgkin Lymphoma Refractory HL |
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |