Clinical trial · Interventional
Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
A Phase II Study of LBH589, a Novel Histone Deacetylase Inhibitor, in Relapsed and Refractory Adult Patients With Acute Leukemia (AL) or in Newly Diagnosed Patients Over the Age of 60
NCT00723203CI-TRIAL-00015569terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to a lack of efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| panobinostat | Drug | Panobinostat | ALIAS |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (panobinostat)
- description
- Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
- interventionNames
- Drug: panobinostat
- Genetic: gene expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Hematological Response Rate
- timeFrame
- Up to 6 cycles of treatment, up to 24 weeks.
- description
- Morphologic CR: morphologic leukemia-free state with absolute neutrophil count \> 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (\<1000/uL) and/or thrombocytopenia (\<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value \> 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.