ID

43417

Description

ODM derived from http://clinicaltrials.gov/show/NCT00405743

Link

http://clinicaltrials.gov/show/NCT00405743

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00405743 Hematologic Malignancies

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 18 Years
Description

Age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
ARM A and B: Phase I CP-4055 single agent
Description

ARM A and B: Phase I CP-4055 single agent

Data type

boolean

Alias
UMLS CUI 2011AA
C1707141
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1254351
Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
Description

Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0277556
SNOMED CT 2011_0131
58184002
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
CL426127
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1705116
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
CL426127
ARM C: CP-4055 in combination with idarubicin
Description

ARM C: CP-4055 in combination with idarubicin

Data type

boolean

Alias
UMLS CUI 2011AA
C1707141
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
Description

Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0278780
UMLS CUI 2011AA
C0205269
SNOMED CT 2011_0131
20646008
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
CL426127
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C1880198
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1705116
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
CL426127
ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
Description

ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin

Data type

boolean

Alias
UMLS CUI 2011AA
C1707141
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C1947911
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
ECOG performance status finding <= 2
Description

Patients must have ECOG performance status (PS) of <= 2. See Appendix 3

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
SNOMED CT 2011_0131
424122007
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
Description

Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0279752
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL414705
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
Description

Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C1707141
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
Description

Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
Description

In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0456962
SNOMED CT 2011_0131
255358001
UMLS CUI 2011AA
C1335499
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0304497
SNOMED CT 2011_0131
373526007
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0018517
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0304497
SNOMED CT 2011_0131
373526007
Patients must have the following clinical laboratory values:
Description

Patients must have the following clinical laboratory values:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
C1522609
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
Description

Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0021622
UMLS CUI 2011AA
C1519815
Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome
Description

Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome

Data type

boolean

Alias
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0017551
SNOMED CT 2011_0131
27503000
MedDRA 14.1
10018267
ICD-10-CM Version 2010
E80.4
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
Description

Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0023418
SNOMED CT 2011_0131
93143009
MedDRA 14.1
10024288
ICD-10-CM Version 2010
C95.9
ICD-9-CM Version 2011
208.9
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
Description

Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0023467
SNOMED CT 2011_0131
91861009
MedDRA 14.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0677881
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
Description

A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0036667
UMLS CUI 2011AA
C0205198
SNOMED CT 2011_0131
62105006
UMLS CUI 2011AA
C2348205
UMLS CUI 2011AA
C0243176
UMLS CUI 2011AA
C0205460
SNOMED CT 2011_0131
12893009
UMLS CUI 2011AA
C0486616
LOINC Version 232
MTHU024868
UMLS CUI 2011AA
C1707141
UMLS CUI 2011AA
C0010711
SNOMED CT 2011_0131
89265009
UMLS CUI 2011AA
C0013710
SNOMED CT 2011_0131
102263004
Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
Description

Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C

Data type

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
Pregnant and nursing patients are excluded
Description

Pregnant and nursing patients are excluded

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
UMLS CUI 2011AA
C0006147
Uncontrolled intercurrent illness
Description

Uncontrolled intercurrent illness

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0277557
SNOMED CT 2011_0131
88472004
Active heart disease
Description

Active heart disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
Description

Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL426127
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C1511636
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0376545
SNOMED CT 2011_0131
129154003
MedDRA 14.1
10066476
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0806909
SNOMED CT 2011_0131
398303009
LOINC Version 232
MTHU008917
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0439596
SNOMED CT 2011_0131
44180009
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0039798
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Description

Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0040539
Performed Exclusion Criterion
Description

Exclusion criteria no. 8 applies only in arm C:

Data type

boolean

Alias
UMLS CUI 2011AA
C0023467
Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
Description

Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0020789
SNOMED CT 2011_0131
372539000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C1514468
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0282564
SNOMED CT 2011_0131
372540003
UMLS CUI 2011AA
C0003174
SNOMED CT 2011_0131
116283009
LOINC Version 232
MTHU015517
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
Age at least 18 Years
Item
Age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
ARM A and B: Phase I CP-4055 single agent
Item
ARM A and B: Phase I CP-4055 single agent
boolean
C1707141 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
Item
Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
boolean
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0679106 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0231175 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
ARM C: CP-4055 in combination with idarubicin
Item
ARM C: CP-4055 in combination with idarubicin
boolean
C1707141 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
Item
Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
boolean
C0278780 (UMLS CUI 2011AA)
C0205269 (UMLS CUI 2011AA)
20646008 (SNOMED CT 2011_0131)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0679106 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0231175 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C1548788 (UMLS CUI 2011AA)
CL426127 (UMLS CUI 2011AA)
ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
Item
ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
boolean
C1707141 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
Patients must have ECOG performance status (PS) of <= 2. See Appendix 3
Item
ECOG performance status finding <= 2
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
Item
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0279752 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414705 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL425201 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
Item
Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C1707141 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
Item
Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
Item
In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0456962 (UMLS CUI 2011AA)
255358001 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0304497 (UMLS CUI 2011AA)
373526007 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0304497 (UMLS CUI 2011AA)
373526007 (SNOMED CT 2011_0131)
Patients must have the following clinical laboratory values:
Item
Patients must have the following clinical laboratory values:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1522609 (UMLS CUI 2011AA)
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
Item
Serum creatinine <= 1.5 x the institutional upper limit of normal (ULN)
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0021622 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome
Item
Total bilirubin <= 1.5 x the ULN unless considered due to Gilbert's syndrome
boolean
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
C0017551 (UMLS CUI 2011AA)
27503000 (SNOMED CT 2011_0131)
10018267 (MedDRA 14.1)
E80.4 (ICD-10-CM Version 2010)
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
Item
Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) <= 2.5 x the ULN unless considered due to organ leukemic involvement
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0023418 (UMLS CUI 2011AA)
93143009 (SNOMED CT 2011_0131)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
Item
Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0023467 (UMLS CUI 2011AA)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
C1514756 (UMLS CUI 2011AA)
C0677881 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
Item
A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0036667 (UMLS CUI 2011AA)
C0205198 (UMLS CUI 2011AA)
62105006 (SNOMED CT 2011_0131)
C2348205 (UMLS CUI 2011AA)
C0243176 (UMLS CUI 2011AA)
C0205460 (UMLS CUI 2011AA)
12893009 (SNOMED CT 2011_0131)
C0486616 (UMLS CUI 2011AA)
MTHU024868 (LOINC Version 232)
C1707141 (UMLS CUI 2011AA)
C0010711 (UMLS CUI 2011AA)
89265009 (SNOMED CT 2011_0131)
C0013710 (UMLS CUI 2011AA)
102263004 (SNOMED CT 2011_0131)
Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
Item
Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
Pregnant and nursing patients are excluded
Item
Pregnant and nursing patients are excluded
boolean
C0549206 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
Uncontrolled intercurrent illness
Item
Uncontrolled intercurrent illness
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0277557 (UMLS CUI 2011AA)
88472004 (SNOMED CT 2011_0131)
Active heart disease
Item
Active heart disease
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
Item
Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
boolean
C1514756 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL426127 (UMLS CUI 2011AA)
C1517586 (UMLS CUI 2011AA)
C1511636 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0376545 (UMLS CUI 2011AA)
129154003 (SNOMED CT 2011_0131)
10066476 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0806909 (UMLS CUI 2011AA)
398303009 (SNOMED CT 2011_0131)
MTHU008917 (LOINC Version 232)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0439596 (UMLS CUI 2011AA)
44180009 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
Item
Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1883420 (UMLS CUI 2011AA)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
Exclusion criteria no. 8 applies only in arm C:
Item
Performed Exclusion Criterion
boolean
C0023467 (UMLS CUI 2011AA)
Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
Item
Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0020789 (UMLS CUI 2011AA)
372539000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0282564 (UMLS CUI 2011AA)
372540003 (SNOMED CT 2011_0131)
C0003174 (UMLS CUI 2011AA)
116283009 (SNOMED CT 2011_0131)
MTHU015517 (LOINC Version 232)
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