Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome (MDS)

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with LBH589 single agent

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CLBH589BDE04

NCT ID:

NCT01034657

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • 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
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location