Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-002011-27-NL
EUCTR2006-002011-27-NLActive, not recruitingPhase 1

A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors - LBH589 in patients with CML (AP and BC) resistant to 2 BCR-ABL kinase inhibitors

ovartis Pharma Services AG0 sites0 target enrollmentStarted: February 16, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Male or female patients aged = 18 years old
  • •Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • •Diagnosis of Ph+ accelerated or blast phase CML defined as:
  • •Accelerated phase - the presence of at least one of the following:
  • •- =15% but <30% blasts in blood or bone marrow
  • •- =30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that <30% blasts present in bone marrow)
  • •- = 20% basophiles in the peripheral blood
  • •- Thrombocytopenia <100 X 109 /L unrelated to therapy
  • •Blast phase (blast crisis) - the presence of one of the following:
  • •- = 30% blasts in the blood, marrow or both
  • •- Extramedullary infiltrates of leukemic cells
  • •Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib) and demonstrated resistance to the most recent kinase inhibitor therapy.
  • •Resistance to a tyrosine kinase inhibitor for eligibility into this protocol is defined as one of the following while the patient was on therapy:
  • •- A patient who was in chronic phase CML who had disease progression to either accelerate phase or blast crisis
  • •- A patient who was in accelerated phase had disease progression to blast crisis
  • •- Patients in AP or BC who did not achieve a hematologic response (defined as not achieving CHR, NEL or RTC) within 3 months of starting therapy
  • •- Patients in AP or BC who had increasing blast counts in peripheral blood or increasing marrow leukemic infiltrate (MLI, the percent marrow blasts multiplied by marrow cellularity)
  • •Patients with a history of intolerance to one BCR-ABL kinase inhibitors (defined as discontinuation of treatment due grade 3 or 4 adverse events related to treatment) will be considered eligible to enter the study if they demonstrate resistance to their most recent BCR-ABL kinase inhibitor as defined above.
  • •Patients must meet special laboratory criteria (details see protocol)
  • •Baseline MUGA or ECHO must demonstrate LVEF = the lower limit of the institutional normal
  • •Patients with an ECOG Performance Status of = 2
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •A candidate for hematopoitic stem cell transplantation (HSCT) (i.e. patient is a candidate has an appropriate donor, and agrees to transplantation)
  • •Prior treatment with an HDAC inhibitor
  • •Patients who are in chronic phase (CP) CML
  • •Impaired cardiac function including any one of the following:
  • •- Screening ECG with a QTc > 450 msec
  • •- Patients with congenital long QT syndrome
  • •- History of sustained ventricular tachycardia
  • •- Any history of ventricular fibrillation or torsades de pointes
  • •- Bradycardia defined as HR < 50 beats per minute (patients with a history of bradycardia who now have a permanent pacemaker and HR = 50 bpm are eligible)
  • •- Patients with a myocardial infarction or unstable angina within 6 months of study entry
  • •- Congestive heart failure (NY Heart Association class III or IV)
  • •- Right bundle branch block and left anterior hemiblock (bifasicular block)
  • •- Uncontrolled hypertension
  • •Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or torsades de pointes listed in [Post-text Supplement 1 ]
  • •Concomitant use of CYP3A4 inhibitors listed in [Post-text Supplement 1]
  • •Concomitant use of any other anti-cancer therapy except anegrilide or hydroxyurea (see Section 6.6.7)
  • •Patients with unresolved diarrhea ?CTCAE grade 1
  • •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
  • •Patients who have received chemotherapy, any investigational drugs (other than BCR-ABL tyrosine kinase inhibitors) or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • •Patients who have received a BCR-ABL tyrosine kinase inhibitor within 1 week of first treatment with LBH589
  • •Female patients who are pregnant or breast feeding, or patients of reproductive potential not using an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589
  • •Male patients whose sexual partners are WOCBP not using effective birth control

Investigators

Similar Trials

Active, not recruiting
Phase 1
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitorsPatients with accelerated phase (AP) or blast crisis (BC) CML who have disease-resistance following treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib).MedDRA version: 8.1 Level: LLT Classification code 10009015 Term: Chronic myeloid leukemia
EUCTR2006-002011-27-FRovartis Pharma Services AG
Active, not recruiting
Not Applicable
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
EUCTR2006-002011-27-BEovartis Pharma Services AG71
Active, not recruiting
Not Applicable
A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitorsPatients with accelerated phase (AP) or blast crisis (BC) CML who have disease-resistance following treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib).MedDRA version: 8.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemia
EUCTR2006-002011-27-DKovartis Pharma Services AG71
Withdrawn
Phase 2
A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitorsChronic myeloid leukemia (CML)10024324
NL-OMON30720ovartis5
Active, not recruiting
Not Applicable
A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
EUCTR2006-000881-35-GBovartis Pharma Services AG120