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LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk MDS (GEPARD)

This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01034657
First received: December 16, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This study will assess the efficacy and safety of LBH589 as single agent and in combination with ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either refractory to ESA or with a low probability of response.


Condition Intervention Phase
Myelodysplastic Syndrome (MDS)
 Drug: oral LBH589/panobinostat
Drug: oral LBH589/panobinostat + Epoitin Alfa HEXAL®
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One Year, Open Label, Multicenter Trial of LBH589 Alone or in Combination With ESA in Red Blood Cell Transfusion-dependent LOW and INT-1 MDS Patients Being Either Refractory to ESA or With a Low Probability of Response - the GErman PAnobinostat Low Risk MDS Trial - GEPARD Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluation of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with LBH589 single agent [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with either LBH589 single agent or with LBH589 and ESA combination treatment. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Evaluation of the objective response rate (CR + PR and HI-P and HI-N) according to modified IWG criteria (Cheson et al.). [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Determination of the IPSS status as well as the single scoring values of the IPSS for patients at baseline and EOS (end of study). [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Determination of the time to response, event-free survival, progression-free survival (PFS), disease-free survival (DFS), time to cause-specific death, and overall survival (OS) in this patient population. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Evaluation of the safety and tolerability profile of LBH589 and LBH589 + ESA in low and INT-1 risk MDS patients [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: November 2009
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: oral LBH589/panobinostat
Experimental: LBH589 + Epoitin Alfa Drug: oral LBH589/panobinostat + Epoitin Alfa HEXAL®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a lower risk MDS (LOW or INT-1 according to IPSS)
  • Red blood cell transfusion dependency of at least 4 Units/8 weeks.
  • Not responding to Erythropoietin stimulating agents (ESA) or having a low chance to do so
  • Age-adjusted normal cardiac, kidney, liver function

Exclusion Criteria:

  • Concomitant use of ESA
  • Concomitant use of any other investigational drug
  • Other malignancy that is not in remission for at least 1 year
  • Platelet Count < 75 x 109/L
  • Impaired cardiac function or clinically significant cardiac diseases

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034657

Contacts
Contact: Novartis Pharmaceuticals +1 800-340-6843

Locations
Germany
Novartis investigative Site Recruiting
Dresden, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01034657     History of Changes
Other Study ID Numbers: CLBH589BDE04, EudraCT 2009-010403-84
Study First Received: December 16, 2009
Last Updated: December 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
MDS
bone marrow
anemia
cytopenia
transfusion dependance
EPO
ESA
erythropoietin
LBH589
Myelodysplastic Syndromes
 hematopoietic improvement
IPSS Low
IPSS Int-1
HI-E
HDAC Inhibitor
HDAC-I
DAC-I
Deacetylase-Inhibitor
Histondeacetylase-Inhibitor
red blood cell transfusions

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
 Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013