Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acu… (NCT00723203) | Clinical Trial Compass
TerminatedPhase 2
Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Stopped: Terminated early due to a lack of efficacy
United States16 participantsStarted 2008-04
Plain-language summary
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Hematological Response Rate
Timeframe: Up to 6 cycles of treatment, up to 24 weeks.