ID

13705

Description

Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00629798

Link

https://clinicaltrials.gov/show/NCT00629798

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00629798

English

Eligibility Acute Myeloid Leukemia NCT00629798

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.
Description

patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients may be of either gender or any ethnic background.
Description

patients may be of either gender or any ethnic background.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0015031
patients must have a karnofsky or lansky performance status > or equal to 70%.
Description

patients must have a karnofsky or lansky performance status > or equal to 70%.

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patients must have adequate organ function measured by:
Description

patients must have adequate organ function measured by:

Data type

boolean

Alias
UMLS CUI [1]
C0678852
* cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.
Description

* cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.

Data type

boolean

Alias
UMLS CUI [1]
C0428772
hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
Description

hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2
Description

renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)
Description

pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)

Data type

boolean

Alias
UMLS CUI [1]
C1516251
each patient must be willing to participate as a research subject and must sign an informed consent form.
Description

each patient must be willing to participate as a research subject and must sign an informed consent form.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
parent or legal guardians of patients who are minors will sign the informed consent form.
Description

parent or legal guardians of patients who are minors will sign the informed consent form.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active cns or skin leukemic involvement
Description

active cns or skin leukemic involvement

Data type

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2]
C1304525
female patients who are pregnant or breast-feeding
Description

female patients who are pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active viral, bacterial or fungal infection
Description

active viral, bacterial or fungal infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patient seropositive for hiv-i/ii; htlv -i/ii
Description

patient seropositive for hiv-i/ii; htlv -i/ii

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0020094
patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
Description

patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.

Data type

boolean

Alias
UMLS CUI [1]
C1504389
patients who have had a previous malignancy that is not in remission.
Description

patients who have had a previous malignancy that is not in remission.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Acute Myeloid Leukemia NCT00629798

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.
boolean
C0001779 (UMLS CUI [1])
patients may be of either gender or any ethnic background.
Item
patients may be of either gender or any ethnic background.
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2])
karnofsky or lansky performance status
Item
patients must have a karnofsky or lansky performance status > or equal to 70%.
boolean
C0206065 (UMLS CUI [1])
organ function
Item
patients must have adequate organ function measured by:
boolean
C0678852 (UMLS CUI [1])
LVEF
Item
* cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.
boolean
C0428772 (UMLS CUI [1])
alt and bilirubin
Item
hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
creatinine or crcl
Item
renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
pulmonary function
Item
pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)
boolean
C1516251 (UMLS CUI [1])
informed consent form
Item
each patient must be willing to participate as a research subject and must sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
informed consent form of minors
Item
parent or legal guardians of patients who are minors will sign the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cns leukemia or skin involvement
Item
active cns or skin leukemic involvement
boolean
C1332884 (UMLS CUI [1])
C1304525 (UMLS CUI [2])
pregnancy or breast feeding
Item
female patients who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
active infection
Item
active viral, bacterial or fungal infection
boolean
C0009450 (UMLS CUI [1])
HIV or HTLV
Item
patient seropositive for hiv-i/ii; htlv -i/ii
boolean
C0019682 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
stem cell transplant
Item
patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
boolean
C1504389 (UMLS CUI [1])
previous malignancy
Item
patients who have had a previous malignancy that is not in remission.
boolean
C0006826 (UMLS CUI [1])
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