Trial record 70 of 138 for:    lbh-589

Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742027
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Classical Hodgkin's Lymphoma (i.e. Nodular Sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte-depleted) Drug: Panobinostat Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : September 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Panobinostat Drug: Panobinostat
Oral 40 mg/dose, three times per week, every week dosing on a 21-day cycle
Other Names:
  • LBH589
  • LBH

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. response rate based on central review of CT scan/MRI [ Time Frame: Throughout study ]
  2. time to response [ Time Frame: Throughout study ]
  3. duration of response [ Time Frame: Throughout study ]
  4. progression-free survival, PFS rate at 6 month and 8 month [ Time Frame: Throughout study ]
  5. Safety and tolerability of panobinostat treatment [ Time Frame: Throughout 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:

  1. Patient age is ≥ 18 years
  2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  3. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte depleted)
  4. 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.

  5. 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

  6. Patient has the following laboratory values (labs may be repeated, if needed, to obtain acceptable values before screen fail):

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L [SI units 1.5 x 109/L]
    • Platelet count ≥ 75 x 109/L
    • Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution Note: Potassium, calcium, magnesium, sodium, and/or phosphorus supplements may be given to correct values that are <LLN. Post-correction values must not be deemed to be a clinically significant abnormality prior to patients being dosed.
    • Serum creatinine ≤ 1.5 x ULN
    • Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)
    • AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement
  7. Clinically euthyroid Note: Patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism.
  8. Written informed consent was obtained from the patient prior to any study-specific screening procedures
  9. Patient has the ability to swallow capsules or tablets

Exclusion Criteria:

  1. Patient has a history of prior treatment with a DAC inhibitor including panobinostat
  2. Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment
  3. Patient has been treated with monoclonal antibody therapy (e.g., rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of study treatment
  4. Patient has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1
  5. Patient has been treated with > 5 prior systemic lines of treatment (see Post-text supplement 2 for definitions and examples)
  6. Patient has received prior radiation therapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to start of study treatment or whose side effects of such therapy have not resolved to ≤ grade 1
  7. Patient is using any anti-cancer therapy concomitantly
  8. Patient treated with allogeneic hematopoietic stem cell transplant who is currently on or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD)
  9. Patient has a 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
  10. Patient has a history of CNS involvement with lymphoma
  11. Patient has impaired cardiac function including any of the following:

    • Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute), QTcF > 450 msec on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
    • Presence of atrial fibrillation (ventricular heart rate >100 bpm)
    • Previous history angina pectoris or acute MI within 6 months
    • Congestive heart failure (New York Heart Association functional classification III-IV) or baseline MUGA/Echo shows LVEF < 45%
  12. Patient has any other clinically significant heart disease (e.g., uncontrolled hypertension)
  13. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
  14. Patient has unresolved diarrhea ≥ grade 2
  15. Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnoea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol
  16. Patient has a known history of HIV seropositivity (screening HIV testing is not required)
  17. Patient is 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
  18. Patient is a woman who is pregnant or breast feeding, or a women of childbearing potential (WOCBP) not willing to use a double method of contraception during the study through 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months). WOCBP must have a negative serum pregnancy test at baseline.
  19. 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):

  20. Fasting blood glucose above 200 mg/dL, at time of PET scan
  21. Inability to lay down for 60 minutes or has a history of claustrophobia
  22. Patient not at a participating center

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00742027

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00742027     History of Changes
Other Study ID Numbers: CLBH589E2214
2008-003016-35 ( EudraCT Number )
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Classical Hodgkin Lymphoma
Classical Hodgkin's Lymphoma
Hodgkin Lymphoma
Hodgkin's Lymphoma
Nodular sclerosing
Lymphocyte depleted
Classical HL
Refractory Hodgkin's Lymphoma
Refractory Hodgkin Lymphoma
Refractory HL

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action