Clinical trial NCT00723203 (phase 2, status: terminated)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: panobinostat
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Reason stopped: 
    terminated early due to a lack of efficacy
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed acute myeloid leukemia or acute
             lymphoblastic leukemia (ALL)

               -  Relapsed or refractory disease

          -  Patients with Philadelphia chromosome-positive (Ph+) ALL refractory to BCR/ABL
             inhibitors are eligible

          -  Patients who have relapsed after prior autologous or allogenic stem cell transplant
             are eligible

          -  No active CNS disease

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Serum albumin ≥ 3 g/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5.0 times ULN if transaminase
             elevation is due to leukemic involvement)

          -  Bilirubin ≤ 1.5 times ULN

          -  Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min

          -  Potassium ≥ lower limit of normal (LLN)

          -  Phosphorous ≥ LLN

          -  Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN

          -  Magnesium ≥ LLN

          -  Thyroid stimulating hormone and free T4 normal (thyroid hormone replacement therapy
             allowed)

          -  LVEF ≥ LLN by MUGA or ECHO

          -  No impaired cardiac function, including any of the following:

               -  QTc > 450 msec

               -  Congenital long QT syndrome

               -  History of sustained ventricular tachycardia

               -  History of ventricular fibrillation or torsades de pointes

               -  Bradycardia (i.e., heart rate < 50 beats per minute)

                    -  Pacemaker allowed provided heart rate ≥ 50 beats per minute

               -  Myocardial infarction or unstable angina within the past 6 months

               -  New York Heart Association class III-IV congestive heart failure

               -  Right bundle branch block and left anterior hemiblock (bifascicular block)

          -  No uncontrolled hypertension

          -  No unresolved diarrhea > CTCAE grade 1

          -  No impaired gastrointestinal (GI) function or GI disease that may significantly alter
             the absorption of oral panobinostat

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective double-barrier contraception during and for 3
             months after completion of study treatment

          -  No other primary malignancy within the past 5 years, other than curatively treated
             carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin

          -  No HIV or hepatitis C positivity

          -  No other concurrent severe and/or uncontrolled medical condition

          -  No significant history of non-compliance to medical regimens or inability to give
             reliable informed consent

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from all prior therapy

          -  More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
             or radiotherapy

          -  More than 4 weeks since prior valproic acid

          -  No other prior treatment with a histone deacetylase inhibitor

          -  No concurrent medication that may cause QTc prolongation or induce torsades de pointes

          -  No concurrent CYP3A4 inhibitors

          -  No concurrent grapefruit, grapefruit juice, or Seville (sour) oranges

          -  No concurrent radiotherapy

          -  No other concurrent anticancer therapy or investigational therapy