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Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by Novartis, December 2008
Sponsored by: Novartis
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 autologous bone marrow transplant and other commonly used chemotherapies such as gemcitabine, vinorelbine, or vinblastine. Safety of panobinostat will also be assessed. Other markers that may correlate with efficacy or safety will be explored.


Condition Intervention Phase
Hodgkin's Lymphoma
Drug: Panobinostat
Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma
Drug Information available for: Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Vinblastine Vinblastine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma After Failure of High-Dose Chemotherapy With Autologous Stem Cell Transfusion and a Gemcitabine- or Vinorelbine- or Vinblastine-Containing Treatment Regimen

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL at 24 weeks post first-dose of study drug [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate based on central review of CT scan/MRI [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • time to response [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • duration of response [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • progression-free survival, PFS rate at 6 month and 8 month [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of panobinostat treatment [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: August 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Panobinostat
Oral 40 mg/dose, three times per week, every week dosing on a 21-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years old
  2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  3. A history of classical HL (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted)
  4. Has progressive disease after receiving high dose chemotherapy with AHSCT
  5. Has progressive disease on or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, after first relapse.
  6. Laboratory values must be in range, more specifically:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L [SI units 1.5 x 109/L]
    • Platelet count ≥ 75 x 109/L
  7. A healthy thyroid

Exclusion Criteria:

  1. History of prior treatment with a DAC inhibitor
  2. Treated with > 5 prior systemic lines of treatment
  3. Treated with allogeneic hematopoietic stem cell transplant who has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD)
  4. History of another primary malignancy ≤ 3 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
  5. History of CNS involvement with lymphoma
  6. Impaired cardiac function or other clinically significant heart disease (e.g., uncontrolled hypertension)
  7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
  8. Ongoing diarrhea ≥ grade 2
  9. Patient has any other concurrent severe and/or uncontrolled medical condition(s) that could cause unacceptable safety risks or compromise compliance with the protocol
  10. History of HIV
  11. Has active bleeding diathesis or is currently being treated with therapeutic doses of sodium warfarin (Coumadin®) or other vitamin K active agents
  12. Using medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, where such treatment cannot be discontinued or switched to a different medication prior to starting study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742027

Contacts
Contact: Novartis US 800 340 6843
Contact: Novartis Basel 41 61 324 1111

  Show 65 Study Locations
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLBH589E2214
Study First Received: August 25, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00742027  
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: Central Administration of Pharmaceutical Affairs;   France: Afssaps - French Health Products Safety Agency;   Germany: Ministry of Health;   Israel: Ministry of Health;   Italy: Agenzia Italiana del Farmaco (AIFA);   Malaysia: Department of public health, DCA (Drug Control Agency);   New Zealand: Medsafe;   Singapore: Health Sciences Authority;   Spain: Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
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

Study placed in the following topic categories:
Lymphatic Diseases
Vinorelbine
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Vinblastine
Gemcitabine
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009