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Trial record 39 of 255 for:    IDARUBICIN

Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML) (PANOBIDARA)

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: NCT00840346
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : December 11, 2018
Information provided by:
PETHEMA Foundation

Brief Summary:
This protocol is a multicenter, national, open-label, single-arm, non-controlled study designed to establish the efficacy (in terms of response and survival) and safety of panobinostat in combination with idarubicin and cytarabine and in monotherapy in patients with newly-diagnosed AML aged 65 years or older.

Condition or disease Intervention/treatment Phase
Acute Myeloblastic Leukaemia Drug: panobinostat Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multicenter, National, Open-Label Study of Panobinostat in Combination With Idarubicin and Cytarabine in Patients Aged 65 Years or Older With Newly Diagnosed Acute Myeloblastic Leukaemia (AML)
Actual Study Start Date : September 2009
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 1
The first patients enrolled in the trial will be successively distributed into three cohorts of patients for each dose level of panobinostat (20 mg, 30 mg, 40 mg) in combination with idarubicin and cytarabine, according to the classical 3+3 schedule
Drug: panobinostat
20 mg, 30 mg, 40 mg in combination with idarubicin and cytarabine, according to the classical 3+3 schedule.

Primary Outcome Measures :
  1. To establish the maximum tolerated dose (MTD) of panobinostat in combination with idarubicin and cytarabine after an induction cycle in patients aged 65 years or older with newly diagnosed AML [ Time Frame: 1 year ]
  2. To analyse efficacy in terms of response to an induction (+/- reinduction) and consolidation regimens with idarubicin and cytarabine in combination with panobinostat [ Time Frame: 2 years ]
  3. To explore efficacy in terms of TTR during a maintenance period with panobinostat as monotherapy in patients aged 65 years or older with newly diagnosed AML [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Investigation of the overall safety and tolerability of panobinostat when given in combination with idarubicin and cytarabine, with special focus on cardiac safety determined by echocardiography and ECG monitoring [ Time Frame: 1 year ]
  2. Survival: Overall survival, disease-free survival, and duration of response [ Time Frame: 4 years ]
  3. Impact of Panobinostat in the reduction of the minimum residual disease (MRD) monitored by multiparametric flow cytometry at different time points of the study: During the induction and consolidation treatments and during the maintenance treatment [ Time Frame: 4 years ]
  4. To investigate the safety and tolerability of panobinostat in combination with idarubicin and cytarabine and of panobinostat as monotherapy measured in terms of incidence of clinical and biological toxicity [ Time Frame: 2 years ]

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
  • The patient should have voluntarily give the informed consent before performing any study test that is not part of the regular care of the patients.
  • Age > 65 years.
  • The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO) (see Appendix 8).
  • The patient should not have received any prior treatment for AML.
  • The patient should have a performance status measured by the ECOG scale <= 2 .
  • The patient should have the following laboratory values prior to the start of the treatment:

    • Aspartate transaminase (AST): ≤ 2.5 x the upper normal ranges.
    • Alanine transaminase (ALT): ≤ 2.5 x the upper normal ranges.
    • Total bilirubin: ≤ 1.5 x the upper normal ranges.
    • Alkaline phosphatase: ≤ 2.5 x the upper normal ranges.
    • Serum creatinine ≤ 2 mg/dl.
    • Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits (WNL) for the institution. Note: Electrolytes (supplemental therapy) should 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.
  • Left ventricular ejection fraction measured by echocardiography ≥ 50%

Exclusion Criteria:

  • Patients previously receiving treatment with histone deacetylase inhibitors (HDACi).
  • Patient will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose.
  • Promyelocytic AML (M3).
  • Secondary AML or previous history of MDS.
  • Male patients whose sexual partners are women of a fertile age and do not use contraceptive.
  • Known brain or leptomeningeal involvement.
  • Presence of any limitation affecting the ability of the patient to comply with the treatment.
  • Patients receiving any investigational agent in the 30 days prior to inclusion.
  • Patient carrier of human immunodeficiency virus (HIV), hepatitis B virus surface antigen or active infection by hepatitis C virus.
  • Presence of heart disorders or clinically significant heart diseases, including any of the following:

    • Congenital QT prolongation "long QT syndrome").
    • History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are acceptable, but this must be discussed with the sponsor prior to inclusion).
    • Any history of ventricular fibrillation or "torsade de pointes".
    • Bradycardia defined as HR < 50 bpm. Patients with pacemakers are eligible if HR ≥ 50 bpm.
    • Screening ECG with QTc > 450 msec.
    • Right bundle branch block + left anterior hemiblock (bifascicular block).
    • Patients with acute myocardial infarction or unstable angina ≤ 6 months before the start of the investigational drug.
    • Any clinically significant heart disease (e.g., NYHA grades III or IV, or baseline LVEF <45%, uncontrolled hypertension, or history of poor compliance of antihypertensive treatment).
  • Gastrointestinal disease making panobinostat absorption significantly difficult.
  • Diarrhea > grade 1 according to CTCAE criteria, version 3.0.
  • Any serious or uncontrolled medical condition (e.g., uncontrolled diabetes, or active or uncontrolled infection), including laboratory disorders that could involve unacceptable risks or affect protocol compliance.
  • Concomitant administration of drugs with a relative risk of increasing the QT interval or inducing "torsade de pointes" if this treatment cannot be discontinued or replaced by another prior to the start of the test drug.
  • Patient has active bleeding diathesis or is currently being treated with therapeutic doses of sodium warfarin (Coumadin®) or other vitamin K active agents Note: mini-dose of Coumadin® (e.g., 1 mg/day) or anti-coagulants given to maintain intravenous line patency, as well as unfractionated or low molecular weight heparin therapy is permitted
  • Patients undergoing major surgery in the four weeks prior to the start of the study treatment or not recovering from the treatment adverse events.
  • Patients with a history of malignancies in the past five years. Basal cell carcinoma, skin epithelioma and carcinoma of the cervix in situ are excluded.

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): NCT00840346

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Hospital Clinic y Provincial de Barcelona
Barcelona, Spain
Hospital Germans Trías i Pujol
Barcelona, Spain
Hospital Santa Creu y Sant Pau. Barcelona
Barcelona, Spain
Hospital 12 de Octubre. Madrid
Madrid, Spain
Hospital Clínico San Carlos. Madrid
Madrid, Spain
Hospital Ramón y Cajal. Madrid
Madrid, Spain
Hospital Morales Messeguer. Murcia
Murcia, Spain
Hospital Univ. La Fe de Valencia
Valencia, Spain
Hospital Lozano Blesa. Zaragoza
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Josep Mª Ribera/Executive Secretary, PETHEMA Identifier: NCT00840346     History of Changes
Other Study ID Numbers: PANOBIDARA
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by PETHEMA Foundation:
Acute Myeloblastic Leukaemia (AML)

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Histone Deacetylase Inhibitors