ID

13589

Description

T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00242515

Link

https://clinicaltrials.gov/show/NCT00242515

Keywords

Versions (1)
  1. 2/18/16 2/18/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00242515

English

Eligibility Acute Myeloid Leukemia NCT00242515

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.
Description

1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
UMLS CUI [3,1]
C3179010
UMLS CUI [3,2]
C0162643
UMLS CUI [4]
C0544452
UMLS CUI [5]
C0277556
2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
Description

2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C2348930
UMLS CUI [2]
C1518999
UMLS CUI [3]
C0596993
3. both patient and donor must sign written informed consent forms.
Description

3. both patient and donor must sign written informed consent forms.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ecog ps </= 2;
Description

ecog ps </= 2;

Data type

boolean

Alias
UMLS CUI [1]
C1520224
ejective fraction > 40%;
Description

ejective fraction > 40%;

Data type

boolean

Alias
UMLS CUI [1]
C0232174
dlco > 40% of predicted;
Description

dlco > 40% of predicted;

Data type

boolean

Alias
UMLS CUI [1]
C1516251
serum bilirubin </= 1.5x institutional upper limit of normal;
Description

serum bilirubin </= 1.5x institutional upper limit of normal;

Data type

boolean

Alias
UMLS CUI [1]
C1278039
sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;
Description

sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
serum creatinine </= 2x upper limit of normal;
Description

serum creatinine </= 2x upper limit of normal;

Data type

boolean

Alias
UMLS CUI [1]
C0201976
creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.
Description

creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.

Data type

boolean

Alias
UMLS CUI [1]
C0373595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. not fulfilling any of the inclusion criteria
Description

1. not fulfilling any of the inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
2. active life-threatening infection
Description

2. active life-threatening infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
3. overt untreated infection
Description

3. overt untreated infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis
Description

4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
5. pregnant or lactating women
Description

5. pregnant or lactating women

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)
Description

6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0019682
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0019163
7. unable to donate bone marrow or peripheral blood due to concurrent medical condition
Description

7. unable to donate bone marrow or peripheral blood due to concurrent medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1305211
UMLS CUI [3]
C0229664
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Similar models

Eligibility Acute Myeloid Leukemia NCT00242515

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
aml or high risk mds
Item
1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C3179010 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
C0544452 (UMLS CUI [4])
C0277556 (UMLS CUI [5])
hla-compatible donor
Item
2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
boolean
C0013018 (UMLS CUI [1,1])
C2348930 (UMLS CUI [1,2])
C1518999 (UMLS CUI [2])
C0596993 (UMLS CUI [3])
written informed consent
Item
3. both patient and donor must sign written informed consent forms.
boolean
C0021430 (UMLS CUI [1])
ECOG
Item
ecog ps </= 2;
boolean
C1520224 (UMLS CUI [1])
ejection fraction
Item
ejective fraction > 40%;
boolean
C0232174 (UMLS CUI [1])
dlco
Item
dlco > 40% of predicted;
boolean
C1516251 (UMLS CUI [1])
bilirubin
Item
serum bilirubin </= 1.5x institutional upper limit of normal;
boolean
C1278039 (UMLS CUI [1])
ALT and AST
Item
sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
creatinine
Item
serum creatinine </= 2x upper limit of normal;
boolean
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.
boolean
C0373595 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
inclusion criteria
Item
1. not fulfilling any of the inclusion criteria
boolean
C1512693 (UMLS CUI [1])
life-threatening infection
Item
2. active life-threatening infection
boolean
C0009488 (UMLS CUI [1])
overt untreated infection
Item
3. overt untreated infection
boolean
C0009488 (UMLS CUI [1])
HIV, hepatitis b or c
Item
4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
pregnancy or lactation
Item
5. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
donor contraindication
Item
6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)
boolean
C0013018 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
unable to donate bone marrow or peripheral blood due to concurrent medical condition
Item
7. unable to donate bone marrow or peripheral blood due to concurrent medical condition
boolean
C0009488 (UMLS CUI [1])
C1305211 (UMLS CUI [2])
C0229664 (UMLS CUI [3])
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