ID

14565

Description

Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01031368

Link

https://clinicaltrials.gov/show/NCT01031368

Keywords

Versions (1)
  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

English

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cohort a: diagnosis of aml by world health organization (who) criteria, either relapsed or refractory; acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and variants] will be eligible only after failure of a regimen containing arsenic trioxide; patients in this cohort must have had an initial remission duration of < 1 year and cannot have received any prior salvage chemotherapy
Description

aml

Data type

boolean

Alias
UMLS CUI [1]
C0023467
cohort b: untreated aml patients, excluding those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
Description

untreated aml

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
cohort c: untreated aml patients, including those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
Description

untreated aml

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [1,3]
C0010802
the first three patients enrolled in cohorts a and b must be less than 60 years old; thereafter, patients aged >= 18 and =< 70 are eligible
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the first three patients enrolled in cohorts a and b must have an eastern cooperative oncology group (ecog) performance status of 0 -1; thereafter, ecog performance status of 0-2 is required
Description

eastern cooperative oncology group (ecog) performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine =< 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age in years)^-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum total bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is thought to be due to gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
Description

serum total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 2.5 x uln, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
Description

aspartate aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201899
alkaline phosphatase =< 2.5 x uln
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C1561546
capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
Description

negative serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430061
male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allogeneic transplant recipients
Description

allogeneic transplant

Data type

boolean

Alias
UMLS CUI [1]
C0149615
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
Description

chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0021081
UMLS CUI [1,4]
C0199974
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease), or other organ system dysfunction
Description

concurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Description

systemic infection and inflammation

Data type

boolean

Alias
UMLS CUI [1]
C3646020
pregnant or lactating patients
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
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Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
aml
Item
cohort a: diagnosis of aml by world health organization (who) criteria, either relapsed or refractory; acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and variants] will be eligible only after failure of a regimen containing arsenic trioxide; patients in this cohort must have had an initial remission duration of < 1 year and cannot have received any prior salvage chemotherapy
boolean
C0023467 (UMLS CUI [1])
untreated aml
Item
cohort b: untreated aml patients, excluding those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
untreated aml
Item
cohort c: untreated aml patients, including those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0010802 (UMLS CUI [1,3])
age
Item
the first three patients enrolled in cohorts a and b must be less than 60 years old; thereafter, patients aged >= 18 and =< 70 are eligible
boolean
C0001779 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status
Item
the first three patients enrolled in cohorts a and b must have an eastern cooperative oncology group (ecog) performance status of 0 -1; thereafter, ecog performance status of 0-2 is required
boolean
C1520224 (UMLS CUI [1])
serum creatinine
Item
serum creatinine =< 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age in years)^-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
boolean
C0201976 (UMLS CUI [1])
serum total bilirubin
Item
serum total bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is thought to be due to gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
boolean
C1278039 (UMLS CUI [1])
aspartate aminotransferase
Item
aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 2.5 x uln, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
boolean
C0201899 (UMLS CUI [1])
alkaline phosphatase
Item
alkaline phosphatase =< 2.5 x uln
boolean
C1561546 (UMLS CUI [1])
informed consent
Item
capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
boolean
C0021430 (UMLS CUI [1])
negative serum pregnancy test
Item
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
boolean
C0430061 (UMLS CUI [1])
Contraceptive methods
Item
male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
allogeneic transplant
Item
allogeneic transplant recipients
boolean
C0149615 (UMLS CUI [1])
chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
Item
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
boolean
C0392920 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
C0199974 (UMLS CUI [1,4])
concurrent disease
Item
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease), or other organ system dysfunction
boolean
C0009488 (UMLS CUI [1])
systemic infection and inflammation
Item
patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
boolean
C3646020 (UMLS CUI [1])
pregnant or lactating
Item
pregnant or lactating patients
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
compliance
Item
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
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