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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.

Phase 2
18 Years
Open (Enrolling)
Classical Hodgkin's Lymphoma (i.e. Nodular Sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte-depleted)

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Trial Information

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.

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

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

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 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

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

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate to therapy with oral panobinostat in patients with refractory/relapsed classical HL at 24 weeks post first-dose of study drug

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

July 2013

Related Keywords:

  • Classical Hodgkin's Lymphoma (i.e. Nodular Sclerosing, Mixed-cellularity, Lymphocyte-rich, Lymphocyte-depleted)
  • 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



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MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(3)Houston, Texas  77030-4009
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Georgia Regents University Cancer Clinical Research UnitAugusta, Georgia  30912
Rush University Medical Center Divisionof Hem/Onc Research(2)Chicago, Illinois  60612
VA Maryland Health Care Dept.of GreenbaumCancerCent(5)Baltimore, Maryland  21201
Dana Farber Cancer Institute Hematology / OncologyBoston, Massachusetts  02115
Karmanos Cancer Institute Div.of Hematology/OncologyDetroit, Michigan  48201
University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3)Philadelphia, Pennsylvania  19104-4283
The Baylor College of Medicine/The Methodist Hospital Cell & Gene Therapy ClinicHouston, Texas  77030