ID

12647

Description

Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT); ODM derived from: https://clinicaltrials.gov/show/NCT01339988

Link

https://clinicaltrials.gov/show/NCT01339988

Keywords

Versions (1)
  1. 12/7/15 12/7/15 -
Uploaded on

December 7, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Leukemias NCT01339988

English

Eligibility Acute Leukemias NCT01339988

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
suitable cord blood from matched unrelated or related donor.
Description

suitable cord blood from matched unrelated or related donor

Data type

boolean

Alias
UMLS CUI [1]
C3653065
cardiac (echo/ekg): shortening fraction ≥ 27 percent
Description

cardiac (echo/ekg): shortening fraction ≥ 27 percent

Data type

boolean

Alias
UMLS CUI [1]
C1335957
electrolytes within normal cchmc limits.
Description

electrolytes within normal cchmc limits

Data type

boolean

Alias
UMLS CUI [1]
C0438240
pulmonary function tests: dlco ≥ 50%
Description

pulmonary function tests

Data type

boolean

Alias
UMLS CUI [1]
C0024119
renal: creatinine clearance/gfr ≥ 60 ml/minute/1.73m2
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
lumbar puncture: no leukemic infiltrate.
Description

lumbar puncture

Data type

boolean

Alias
UMLS CUI [1]
C0037943
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
Description

cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
Description

documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.

Data type

boolean

Alias
UMLS CUI [1]
C0009450
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
Description

hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant

Data type

boolean

Alias
UMLS CUI [1]
C1848701
UMLS CUI [2]
C0201913
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen.
Description

patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals. patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.
Description

patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
Description

patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
UMLS CUI [3]
C0700589
hiv seropositive patients
Description

hiv seropositive patients

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Acute Leukemias NCT01339988

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
suitable cord blood from matched unrelated or related donor
Item
suitable cord blood from matched unrelated or related donor.
boolean
C3653065 (UMLS CUI [1])
cardiac (echo/ekg): shortening fraction ≥ 27 percent
Item
cardiac (echo/ekg): shortening fraction ≥ 27 percent
boolean
C1335957 (UMLS CUI [1])
electrolytes within normal cchmc limits
Item
electrolytes within normal cchmc limits.
boolean
C0438240 (UMLS CUI [1])
pulmonary function tests
Item
pulmonary function tests: dlco ≥ 50%
boolean
C0024119 (UMLS CUI [1])
creatinine clearance
Item
renal: creatinine clearance/gfr ≥ 60 ml/minute/1.73m2
boolean
C0373595 (UMLS CUI [1])
lumbar puncture
Item
lumbar puncture: no leukemic infiltrate.
boolean
C0037943 (UMLS CUI [1])
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
Item
cbc: anc ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
Item
documented hsv and cmv titers, hepatitis b surface antigen, hepatitis c by serology, hiv by serology: all negative.
boolean
C0009450 (UMLS CUI [1])
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
Item
hepatic transaminases < 2.5x normal; total bilirubin < 2 mg/dl patients who do not meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with program director of blood and marrow transplant
boolean
C1848701 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen
Item
patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the pre-transplant conditioning regimen.
boolean
C0009488 (UMLS CUI [1])
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals
Item
patients with uncontrolled (culture or biopsy positive) infections requiring intravenous antivirals, antibiotics, or antifungals. patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.
boolean
C0009450 (UMLS CUI [1])
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
Item
patients who are pregnant or lactating. patients of childbearing potential must practice an effective method of birth control while participating on this treatment plan.
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
hiv seropositive patients
Item
hiv seropositive patients
boolean
C0019699 (UMLS CUI [1])
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