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

NCT ID: NCT01034657

Last Updated: 2017-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-08-31

Brief Summary

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This study assessed 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. The study had a non-randomized core phase followed by a randomized phase.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome (MDS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBH589

During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.

LBH589 + Epoetin Alfa

During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.

Epoetin Alfa

Intervention Type DRUG

Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.

Interventions

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LBH589

LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.

Intervention Type DRUG

Epoetin Alfa

Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.

Intervention Type DRUG

Other Intervention Names

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Panobinostat ESA, HEXAL®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bonn, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Duisburg, , Germany

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Göttingen, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT 2009-010403-84

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-010403-84

Identifier Type: -

Identifier Source: secondary_id

CLBH589BDE04

Identifier Type: -

Identifier Source: org_study_id

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