ID

12810

Beschrijving

Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01744223

Link

https://clinicaltrials.gov/show/NCT01744223

Trefwoorden

Versies (1)
  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01744223

Engels

Eligibility Acute Lymphoblastic Leukemia NCT01744223

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
Beschrijving

lack of suitable stem cell donor or rapidly progressive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0375877
UMLS CUI [2]
C0677932
hla typing will be performed at high resolution (allele level) for the hla-a, -b, cw, and drbl, and loci. a minimum match of 5/10 is required. the donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: hla-a, hla-b, hla-cw, and hla- drb1.
Beschrijving

hla typing

Datatype

boolean

Alias
UMLS CUI [1]
C0242318
subjects with adequate physical function as measured by:a)cardiac: left ventricular ejection fraction at rest must be >35 percent, or shortening fraction > 25percent. b)hepatic: bilirubin < 2.5 mg/dl; and alt, ast, and alkaline phosphatase < 5 x uln. c)renal: serum creatinine within normal range for age, or creatinine clearance or gfr > 40 ml/min/1.73m2. d)pulmonary: fev 1, fvc, dlco (diffusion capacity) > 50 percent predicted (corrected for hemoglobin); or 02 saturation > 92 percent on room air.
Beschrijving

adequate physical function

Datatype

boolean

Alias
UMLS CUI [1]
C0231162
clinical diagnosis of one of the following: acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
Beschrijving

acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3]
C0024299
subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
performance status: karnofsky/lansky score > 60 percent.
Beschrijving

karnofsky performance

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hla-matched, related or 7-or 8/8 allele matched (hla-a,-b,-cw,-drbl) unrelated donor able to donate.
Beschrijving

stem cell donor available

Datatype

boolean

Alias
UMLS CUI [1,1]
C0375877
UMLS CUI [1,2]
C0470187
autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
Beschrijving

autologous hematopoietic stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C1831743
pregnancy or breast-feeding.
Beschrijving

pregnant or breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
evidence of hiv infection or known hiv positive serology.
Beschrijving

hiv positivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
Beschrijving

current uncontrolled bacterial, viral or fungal infection

Datatype

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0026946
non-hematologic malignancy within prior three (3) years.
Beschrijving

non-hematologic malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0935681
prior allogeneic hematopoietic stem cell transplant.
Beschrijving

allogeneic hematopoietic stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C2242529
subjects with a history of primary idiopathic myelofibrosis.
Beschrijving

idiopathic myelofibrosis

Datatype

boolean

Alias
UMLS CUI [1]
C0001815
bovine product allergy.
Beschrijving

bovine product allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0036774
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01744223

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
lack of suitable stem cell donor or rapidly progressive disease
Item
lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
boolean
C0375877 (UMLS CUI [1])
C0677932 (UMLS CUI [2])
hla typing
Item
hla typing will be performed at high resolution (allele level) for the hla-a, -b, cw, and drbl, and loci. a minimum match of 5/10 is required. the donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: hla-a, hla-b, hla-cw, and hla- drb1.
boolean
C0242318 (UMLS CUI [1])
adequate physical function
Item
subjects with adequate physical function as measured by:a)cardiac: left ventricular ejection fraction at rest must be >35 percent, or shortening fraction > 25percent. b)hepatic: bilirubin < 2.5 mg/dl; and alt, ast, and alkaline phosphatase < 5 x uln. c)renal: serum creatinine within normal range for age, or creatinine clearance or gfr > 40 ml/min/1.73m2. d)pulmonary: fev 1, fvc, dlco (diffusion capacity) > 50 percent predicted (corrected for hemoglobin); or 02 saturation > 92 percent on room air.
boolean
C0231162 (UMLS CUI [1])
acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
Item
clinical diagnosis of one of the following: acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
chemotherapy
Item
subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
boolean
C0392920 (UMLS CUI [1])
karnofsky performance
Item
performance status: karnofsky/lansky score > 60 percent.
boolean
C0206065 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
stem cell donor available
Item
hla-matched, related or 7-or 8/8 allele matched (hla-a,-b,-cw,-drbl) unrelated donor able to donate.
boolean
C0375877 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
autologous hematopoietic stem cell transplant
Item
autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
boolean
C1831743 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnancy or breast-feeding.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hiv positivity
Item
evidence of hiv infection or known hiv positive serology.
boolean
C0019699 (UMLS CUI [1])
current uncontrolled bacterial, viral or fungal infection
Item
current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
non-hematologic malignancy
Item
non-hematologic malignancy within prior three (3) years.
boolean
C0935681 (UMLS CUI [1])
allogeneic hematopoietic stem cell transplant
Item
prior allogeneic hematopoietic stem cell transplant.
boolean
C2242529 (UMLS CUI [1])
idiopathic myelofibrosis
Item
subjects with a history of primary idiopathic myelofibrosis.
boolean
C0001815 (UMLS CUI [1])
bovine product allergy
Item
bovine product allergy.
boolean
C0020517 (UMLS CUI [1])
C0036774 (UMLS CUI [2])
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