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Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk MDS or AML (PANOBEST)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome, Acute Myeloid Leukemia

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Trial Information

Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk MDS or AML (PANOBEST)


Inclusion Criteria:



- AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as
one or more of the following criteria:

- refractory to or relapsed after at least one cycle of standard chemotherapy

- > 10% bone marrow blasts at day 15 of the first induction cycle

- adverse risk cytogenetics including complex karyotype (≥ 3 abnormalities or
abnormalities of chromosomes 3, 5 or 7) regardless of stage

- secondary to MDS or radio-/chemotherapy or

- MDS RAEB according to the WHO classification or intermediate-2 or high-risk according
to IPSS or

- Chronic myelomonocytic leukemia (CMML) with ≥ 5% bone marrow blasts and

- Allogeneic HSCT with reduced intensity conditioning (see Section 15.1 for
definition) performed within 60 - 150 days prior to study entry

- Complete hematologic remission documented by bone marrow aspiration within 28
days prior to study entry

Exclusion Criteria:

- Active acute GvHD overall grade 2 - 4

- Prior treatment with a deacetylase (DAC) inhibitor

- Patients with impaired cardiac function or other concurrent severe and/or
uncontrolled medical conditions

- Clinical symptoms suggesting central nervous system (CNS) leukemia

- Patient has an impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral panobinostat

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of panobinostat

Outcome Time Frame:

after 28 days of administration

Safety Issue:

Yes

Principal Investigator

Gesine Bug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johann Wolfgang Goethe University Hospitals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CLBH589 BDE05T

NCT ID:

NCT01451268

Start Date:

January 2011

Completion Date:

August 2017

Related Keywords:

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • 60 to 150 Days After Allogeneic Stem Cell Transplantation
  • High Risk MDS
  • MDS
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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