ID

13745

Description

A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01055483

Link

https://clinicaltrials.gov/show/NCT01055483

Keywords

Versions (1)
  1. 3/2/16 3/2/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 2, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01055483

English

Eligibility Acute Myeloid Leukemia NCT01055483

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
Description

patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0456521
UMLS CUI [2]
C0023487
first relapsed aml
Description

first relapsed aml

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C0205435
primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
Description

primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
age more than 18 years
Description

age more than 18 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status < 2
Description

ecog performance status < 2

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with deacetylase inhibitor
Description

prior treatment with deacetylase inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C1512474
UMLS CUI [1,2]
C1514463
concurrent therapy with any other investigational agent
Description

concurrent therapy with any other investigational agent

Data type

boolean

Alias
UMLS CUI [1,1]
C1875319
UMLS CUI [1,2]
C0009429
patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
Description

patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
clinical symptoms suggesting cns leukemia
Description

clinical symptoms suggesting cns leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1332884
UMLS CUI [1,2]
C1457887
lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
Description

lvef below 45% other protocol-defined inclusion/exclusion criteria may apply

Data type

boolean

Alias
UMLS CUI [1]
C0428772
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Similar models

Eligibility Acute Myeloid Leukemia NCT01055483

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML cytopathologically confirmed, except APL
Item
patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
boolean
C0023467 (UMLS CUI [1,1])
C0456521 (UMLS CUI [1,2])
C0023487 (UMLS CUI [2])
first relapsed AML
Item
first relapsed aml
boolean
C0023467 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
refractory aml
Item
primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
age
Item
age more than 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
deacetylase inhibitor
Item
prior treatment with deacetylase inhibitor
boolean
C1512474 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
investigational agent
Item
concurrent therapy with any other investigational agent
boolean
C1875319 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
doxorubicin cumulative dose
Item
patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
cns leukemia
Item
clinical symptoms suggesting cns leukemia
boolean
C1332884 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
LVEF
Item
lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
boolean
C0428772 (UMLS CUI [1])
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