ID

12810

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.12.15 21.12.15 -
Hochgeladen am

21. Dezember 2015

DOI

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Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT01744223

Englisch

Eligibility Acute Lymphoblastic Leukemia NCT01744223

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

lack of suitable stem cell donor or rapidly progressive disease

Datentyp

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.
Beschreibung

hla typing

Datentyp

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.
Beschreibung

adequate physical function

Datentyp

boolean

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

acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma

Datentyp

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).
Beschreibung

chemotherapy

Datentyp

boolean

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

karnofsky performance

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
Exclusion Criteria
Beschreibung

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.
Beschreibung

stem cell donor available

Datentyp

boolean

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

autologous hematopoietic stem cell transplant

Datentyp

boolean

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

pregnant or breastfeeding

Datentyp

boolean

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

hiv positivity

Datentyp

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).
Beschreibung

current uncontrolled bacterial, viral or fungal infection

Datentyp

boolean

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

non-hematologic malignancy

Datentyp

boolean

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

allogeneic hematopoietic stem cell transplant

Datentyp

boolean

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

idiopathic myelofibrosis

Datentyp

boolean

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

bovine product allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0036774
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Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukemia NCT01744223

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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