ID

16567

Description

Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00113646

Link

https://clinicaltrials.gov/show/NCT00113646

Keywords

Versions (2)
  1. 7/24/16 7/24/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

July 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00113646

English

Eligibility Lymphoma NCT00113646

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00113646
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease status: nhl, hd, mm that are chemorefractory or relapsed; cll that is rai stage iii or iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to > 2 cycles of chemotherapy regimens; cml in accelerated or blast phase; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
Description

chemorefractory or relapsed nhl, hd, mm / CLL rai stage / accelerated or blast phase CML / MDS with critical cytopenias / patients with previous stem cell transplants / other hematological disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C3844738
UMLS CUI [1,2]
C0334619
UMLS CUI [2,1]
C3844738
UMLS CUI [2,2]
C0026764
UMLS CUI [3,1]
C0023434
UMLS CUI [3,2]
|C0023472
UMLS CUI [4]
C0005699
UMLS CUI [5,1]
C3463824
UMLS CUI [5,2]
C1263979
UMLS CUI [6]
C1504389
UMLS CUI [7]
C0018939
estimated disease free survival of less than one year
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of 0, 1, or 2
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
hla 1 to 3 mismatched (at a, b, dr loci) related donor
Description

hla mismatched related donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0549171
UMLS CUI [1,2]
C0029206
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cardiac disease: symptomatic congestive heart failure, ejection fraction of < 45%, active angina pectoris or uncontrolled hypertension.
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0002962
UMLS CUI [4]
C1868885
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0085581
UMLS CUI [3]
C1516251
renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min
Description

renal disease

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphate, sgpt or sgot > 3 x normal
Description

hepatic disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201850
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
Description

neurologic disease

Data type

boolean

Alias
UMLS CUI [1]
C0270612
UMLS CUI [2]
C0348374
UMLS CUI [3]
C0233514
hiv antibody or hepatitis b surface antigen positivity
Description

HIV or HBV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
uncontrolled infection
Description

uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
presence of hama or haha in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
Description

presence of hama or haha

Data type

boolean

Alias
UMLS CUI [1]
C1868746
UMLS CUI [2]
C1295018
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Similar models

Eligibility Lymphoma NCT00113646

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00113646
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
chemorefractory or relapsed nhl, hd, mm / CLL rai stage / accelerated or blast phase CML / MDS with critical cytopenias / patients with previous stem cell transplants / other hematological disorders
Item
disease status: nhl, hd, mm that are chemorefractory or relapsed; cll that is rai stage iii or iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to > 2 cycles of chemotherapy regimens; cml in accelerated or blast phase; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
boolean
C3844738 (UMLS CUI [1,1])
C0334619 (UMLS CUI [1,2])
C3844738 (UMLS CUI [2,1])
C0026764 (UMLS CUI [2,2])
C0023434 (UMLS CUI [3,1])
|C0023472 (UMLS CUI [3,2])
C0005699 (UMLS CUI [4])
C3463824 (UMLS CUI [5,1])
C1263979 (UMLS CUI [5,2])
C1504389 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
life expectancy
Item
estimated disease free survival of less than one year
boolean
C0023671 (UMLS CUI [1])
ecog performance status
Item
ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
hla mismatched related donor
Item
hla 1 to 3 mismatched (at a, b, dr loci) related donor
boolean
C0549171 (UMLS CUI [1,1])
C0029206 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
cardiac disease
Item
cardiac disease: symptomatic congestive heart failure, ejection fraction of < 45%, active angina pectoris or uncontrolled hypertension.
boolean
C0018802 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
pulmonary disease
Item
pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
boolean
C0024117 (UMLS CUI [1])
C0085581 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
renal disease
Item
renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
hepatic disease
Item
hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphate, sgpt or sgot > 3 x normal
boolean
C1278039 (UMLS CUI [1])
C0201850 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
neurologic disease
Item
neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
boolean
C0270612 (UMLS CUI [1])
C0348374 (UMLS CUI [2])
C0233514 (UMLS CUI [3])
HIV or HBV positivity
Item
hiv antibody or hepatitis b surface antigen positivity
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
uncontrolled infection
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
presence of hama or haha
Item
presence of hama or haha in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
boolean
C1868746 (UMLS CUI [1])
C1295018 (UMLS CUI [2])
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