ID

41123

Description

SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00798213

Link

https://clinicaltrials.gov/show/NCT00798213

Keywords

Versions (1)
  1. 6/26/20 6/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 26, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT00798213

English

Eligibility Leukemia, Myeloid, Acute NCT00798213

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for participants with aml:
Description

Study Subject AML

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0023467
age >=60 years, either sex, any race.
Description

Age | Racial group Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
diagnosis of cd33-positive aml by world health organization criteria.
Description

AML CD33 Positive WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C4329511
UMLS CUI [1,3]
C1301142
must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
Description

First Relapse | Relapse second | Unresponsive to Salvage Therapy First | Patient Inappropriate Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C4054953
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C0085405
UMLS CUI [3,3]
C0205435
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0040732
acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
Description

Acute Promyelocytic Leukemia | Recurrent disease Post Therapeutic procedure | tretinoin | Arsenic Trioxide Regimen

Data type

boolean

Alias
UMLS CUI [1]
C0023487
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C0040845
UMLS CUI [4]
C5204835
for participants with all:
Description

Study Subject ALL

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0023449
age >=18 years, either sex, any race.
Description

Age | Racial group Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
diagnosis of all by world health organization criteria.
Description

ALL WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C1301142
must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
Description

First Relapse | Relapse second | Unresponsive to Salvage Therapy First | Patient Inappropriate Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C4054953
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0205269
UMLS CUI [3,2]
C0085405
UMLS CUI [3,3]
C0205435
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1273390
eastern cooperative oncology group performance status of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal, and hepatic organ function and laboratory parameters.
Description

Hematologic function | Renal function | Liver function | Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1254595
receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
Description

hydroxyurea | Leukapheresis | Reduction White blood cell count increased | Hydroxyurea Discontinued | Leukapheresis Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2]
C0023416
UMLS CUI [3,1]
C0392756
UMLS CUI [3,2]
C0750426
UMLS CUI [4,1]
C0020402
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C0023416
UMLS CUI [5,2]
C1444662
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system leukemia.
Description

Central nervous system leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
previous hematopoietic stem cell transplantation.
Description

Hemopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0472699
previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors.
Description

SCH 727965 | Cyclin-Dependent Kinase Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C2711996
UMLS CUI [2]
C0919418
for aml, previous treatment with gemtuzumab ozogamicin.
Description

Prior Therapy AML | gemtuzumab ozogamicin

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023467
UMLS CUI [2]
C1533699
known hiv infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
known active hepatitis b or c.
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT00798213

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject AML
Item
for participants with aml:
boolean
C0681850 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Age | Racial group Any
Item
age >=60 years, either sex, any race.
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
AML CD33 Positive WHO tumor classification
Item
diagnosis of cd33-positive aml by world health organization criteria.
boolean
C0023467 (UMLS CUI [1,1])
C4329511 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
First Relapse | Relapse second | Unresponsive to Salvage Therapy First | Patient Inappropriate Transplantation
Item
must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
boolean
C4054953 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C0085405 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0040732 (UMLS CUI [4,3])
Acute Promyelocytic Leukemia | Recurrent disease Post Therapeutic procedure | tretinoin | Arsenic Trioxide Regimen
Item
acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
boolean
C0023487 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0040845 (UMLS CUI [3])
C5204835 (UMLS CUI [4])
Study Subject ALL
Item
for participants with all:
boolean
C0681850 (UMLS CUI [1,1])
C0023449 (UMLS CUI [1,2])
Age | Racial group Any
Item
age >=18 years, either sex, any race.
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
ALL WHO tumor classification
Item
diagnosis of all by world health organization criteria.
boolean
C0023449 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
First Relapse | Relapse second | Unresponsive to Salvage Therapy First | Patient Inappropriate Curative treatment
Item
must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
boolean
C4054953 (UMLS CUI [1])
C0035020 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3,1])
C0085405 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1273390 (UMLS CUI [4,3])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Laboratory Results
Item
adequate hematologic, renal, and hepatic organ function and laboratory parameters.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
hydroxyurea | Leukapheresis | Reduction White blood cell count increased | Hydroxyurea Discontinued | Leukapheresis Discontinued
Item
receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
boolean
C0020402 (UMLS CUI [1])
C0023416 (UMLS CUI [2])
C0392756 (UMLS CUI [3,1])
C0750426 (UMLS CUI [3,2])
C0020402 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0023416 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Central nervous system leukemia
Item
known central nervous system leukemia.
boolean
C1332884 (UMLS CUI [1])
Hemopoietic stem cell transplant
Item
previous hematopoietic stem cell transplantation.
boolean
C0472699 (UMLS CUI [1])
SCH 727965 | Cyclin-Dependent Kinase Inhibitor
Item
previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors.
boolean
C2711996 (UMLS CUI [1])
C0919418 (UMLS CUI [2])
Prior Therapy AML | gemtuzumab ozogamicin
Item
for aml, previous treatment with gemtuzumab ozogamicin.
boolean
C1514463 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C1533699 (UMLS CUI [2])
HIV Infection
Item
known hiv infection.
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
known active hepatitis b or c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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