ID

20172

Beschreibung

Autologous Transplantation for Chronic Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01003054

Link

https://clinicaltrials.gov/show/NCT01003054

Stichworte

Versionen (1)
  1. 09.02.17 09.02.17 -
Hochgeladen am

9. Februar 2017

DOI

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Eligibility Chronic Myelogenous Leukemia NCT01003054

Englisch

Eligibility Chronic Myelogenous Leukemia NCT01003054

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. criteria for hematopoietic stem cell collection and cryopreservation: a- patients with philadelphia chromosome positive cml < age 70 who achieve a cytogenetic remission (no ph+ cells on bone marrow cytogenetics, at least twenty metaphases counted) are eligible for hematopoietic stem cell collection and cryopreservation. b-
Beschreibung

Hematopoietic stem cells Collection | Hematopoietic stem cells Cryopreservation | Philadelphia chromosome positive chronic myelogenous leukemia | Age | Cytogenetic Complete Response | Bone Marrow Cytogenetic Analysis Cells Philadelphia positive Absent | Metaphase Quantity Count

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018956
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0018956
UMLS CUI [2,2]
C0010405
UMLS CUI [3]
C0279543
UMLS CUI [4]
C0001779
UMLS CUI [5]
C4050364
UMLS CUI [6,1]
C0005953
UMLS CUI [6,2]
C0752095
UMLS CUI [6,3]
C0007634
UMLS CUI [6,4]
C0457340
UMLS CUI [6,5]
C0332197
UMLS CUI [7,1]
C1621812
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0750480
patients must have a zubrod ps <2. c.creatinine < 1.8 mg/dl d.serum bilirubin < 1.5 mg/dl e. sgpt < 3 x normal values f. patients with an hla identical sibling are eligible if they refuse allogeneic transplantation.
Beschreibung

Zubrod Performance Status | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Sibling HLA Identical | Homologous Transplantation Refused

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0037047
UMLS CUI [5,2]
C0019721
UMLS CUI [5,3]
C0205280
UMLS CUI [6,1]
C0040739
UMLS CUI [6,2]
C1705116
2. patients are eligible for high dose therapy and autologous transplantation if they meet the following criteria (numbered 2-13): - cytogenetic relapse characterized by > 10% ph+ metaphases (by fish analysis or > 2 of 20 ph+ metaphases on 2 consecutive cytogenetic studies at least 1 month apart).
Beschreibung

Therapeutic procedure High dose | Transplantation, Autologous | Recurrent disease Cytogenetic Analysis | Metaphase Philadelphia positive Quantity Cytogenetic Analysis | Metaphase Philadelphia positive Percentage Fluorescent in Situ Hybridization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0040736
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0752095
UMLS CUI [4,1]
C1621812
UMLS CUI [4,2]
C0457340
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0752095
UMLS CUI [5,1]
C1621812
UMLS CUI [5,2]
C0457340
UMLS CUI [5,3]
C0439165
UMLS CUI [5,4]
C0162789
3. cytogenetic relapse (as above) with hematologic remission or chronic phase disease, or
Beschreibung

Recurrent disease Cytogenetic Analysis | Decrease Hematologic | Leukemia, Myeloid, Chronic-Phase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0752095
UMLS CUI [2,1]
C0547047
UMLS CUI [2,2]
C0205488
UMLS CUI [3]
C0023474
4. accelerated phase or second or subsequent chronic phase.
Beschreibung

Leukemia, Myeloid, Accelerated Phase | Leukemia, Myeloid, Chronic-Phase second | Leukemia, Myeloid, Chronic-Phase Following

Datentyp

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2,1]
C0023474
UMLS CUI [2,2]
C0205436
UMLS CUI [3,1]
C0023474
UMLS CUI [3,2]
C0332282
5. availability of stored autologous hematopoietic stem cells collected when the patient was in cytogenetic complete remission (0 of >= 20 metaphases positive for ph+
Beschreibung

Autologous Hematopoietic stem cells Available | Autologous Hematopoietic stem cells Cytogenetic Complete Response | Metaphase Cells Philadelphia positive Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018956
UMLS CUI [1,2]
C0439859
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0018956
UMLS CUI [2,2]
C0439859
UMLS CUI [2,3]
C4050364
UMLS CUI [3,1]
C1621812
UMLS CUI [3,2]
C0007634
UMLS CUI [3,3]
C0457340
UMLS CUI [3,4]
C1265611
cells).a minimum of 0.5 x 10 6 cd34 positive cells/kg or 1 x 10 8 total nucleated cells/kg must be available.
Beschreibung

Cell positive for CD34 antigen Unit/kilogram Available | Nucleated cell Total Unit/kilogram Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0882849
UMLS CUI [1,2]
C1300561
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C1180059
UMLS CUI [2,2]
C0439810
UMLS CUI [2,3]
C1300561
UMLS CUI [2,4]
C0470187
6. age < 70 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. zubrod ps <=2.
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
8. creatinine < 1.8 mg/dl.
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
9. cardiac ejection fraction > 40%.
Beschreibung

Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
10. dlco > 50% of the predicted value.
Beschreibung

Carbon Monoxide Diffusing Capability Test

Datentyp

boolean

Alias
UMLS CUI [1]
C1516251
11. serum bilirubin < 1.5 mg/dl.
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
12. sgpt < 3 x normal values.
Beschreibung

Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
13. patients with an hla identical sibling are eligible if they refuse allogeneic transplantation.
Beschreibung

Sibling HLA Identical | Homologous Transplantation Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0019721
UMLS CUI [1,3]
C0205280
UMLS CUI [2,1]
C0040739
UMLS CUI [2,2]
C1705116
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
Beschreibung

Life-threatening infections Uncontrolled | Comorbidity Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
2. hiv positivity.
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
3. pregnant or lactating women.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. blast crisis (>30% blasts in blood or marrow)
Beschreibung

Blast Phase

Datentyp

boolean

Alias
UMLS CUI [1]
C0005699
5. hepatitis b or c positivity.
Beschreibung

Hepatitis B positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
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Ähnliche Modelle

Eligibility Chronic Myelogenous Leukemia NCT01003054

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hematopoietic stem cells Collection | Hematopoietic stem cells Cryopreservation | Philadelphia chromosome positive chronic myelogenous leukemia | Age | Cytogenetic Complete Response | Bone Marrow Cytogenetic Analysis Cells Philadelphia positive Absent | Metaphase Quantity Count
Item
1. criteria for hematopoietic stem cell collection and cryopreservation: a- patients with philadelphia chromosome positive cml < age 70 who achieve a cytogenetic remission (no ph+ cells on bone marrow cytogenetics, at least twenty metaphases counted) are eligible for hematopoietic stem cell collection and cryopreservation. b-
boolean
C0018956 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0018956 (UMLS CUI [2,1])
C0010405 (UMLS CUI [2,2])
C0279543 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C4050364 (UMLS CUI [5])
C0005953 (UMLS CUI [6,1])
C0752095 (UMLS CUI [6,2])
C0007634 (UMLS CUI [6,3])
C0457340 (UMLS CUI [6,4])
C0332197 (UMLS CUI [6,5])
C1621812 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0750480 (UMLS CUI [7,3])
Zubrod Performance Status | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Sibling HLA Identical | Homologous Transplantation Refused
Item
patients must have a zubrod ps <2. c.creatinine < 1.8 mg/dl d.serum bilirubin < 1.5 mg/dl e. sgpt < 3 x normal values f. patients with an hla identical sibling are eligible if they refuse allogeneic transplantation.
boolean
C3714786 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0037047 (UMLS CUI [5,1])
C0019721 (UMLS CUI [5,2])
C0205280 (UMLS CUI [5,3])
C0040739 (UMLS CUI [6,1])
C1705116 (UMLS CUI [6,2])
Therapeutic procedure High dose | Transplantation, Autologous | Recurrent disease Cytogenetic Analysis | Metaphase Philadelphia positive Quantity Cytogenetic Analysis | Metaphase Philadelphia positive Percentage Fluorescent in Situ Hybridization
Item
2. patients are eligible for high dose therapy and autologous transplantation if they meet the following criteria (numbered 2-13): - cytogenetic relapse characterized by > 10% ph+ metaphases (by fish analysis or > 2 of 20 ph+ metaphases on 2 consecutive cytogenetic studies at least 1 month apart).
boolean
C0087111 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0040736 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C0752095 (UMLS CUI [3,2])
C1621812 (UMLS CUI [4,1])
C0457340 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0752095 (UMLS CUI [4,4])
C1621812 (UMLS CUI [5,1])
C0457340 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
C0162789 (UMLS CUI [5,4])
Recurrent disease Cytogenetic Analysis | Decrease Hematologic | Leukemia, Myeloid, Chronic-Phase
Item
3. cytogenetic relapse (as above) with hematologic remission or chronic phase disease, or
boolean
C0277556 (UMLS CUI [1,1])
C0752095 (UMLS CUI [1,2])
C0547047 (UMLS CUI [2,1])
C0205488 (UMLS CUI [2,2])
C0023474 (UMLS CUI [3])
Leukemia, Myeloid, Accelerated Phase | Leukemia, Myeloid, Chronic-Phase second | Leukemia, Myeloid, Chronic-Phase Following
Item
4. accelerated phase or second or subsequent chronic phase.
boolean
C0023472 (UMLS CUI [1])
C0023474 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0023474 (UMLS CUI [3,1])
C0332282 (UMLS CUI [3,2])
Autologous Hematopoietic stem cells Available | Autologous Hematopoietic stem cells Cytogenetic Complete Response | Metaphase Cells Philadelphia positive Quantity
Item
5. availability of stored autologous hematopoietic stem cells collected when the patient was in cytogenetic complete remission (0 of >= 20 metaphases positive for ph+
boolean
C0018956 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0018956 (UMLS CUI [2,1])
C0439859 (UMLS CUI [2,2])
C4050364 (UMLS CUI [2,3])
C1621812 (UMLS CUI [3,1])
C0007634 (UMLS CUI [3,2])
C0457340 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Cell positive for CD34 antigen Unit/kilogram Available | Nucleated cell Total Unit/kilogram Available
Item
cells).a minimum of 0.5 x 10 6 cd34 positive cells/kg or 1 x 10 8 total nucleated cells/kg must be available.
boolean
C0882849 (UMLS CUI [1,1])
C1300561 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C1180059 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C1300561 (UMLS CUI [2,3])
C0470187 (UMLS CUI [2,4])
Age
Item
6. age < 70 years.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
7. zubrod ps <=2.
boolean
C3714786 (UMLS CUI [1])
Creatinine measurement, serum
Item
8. creatinine < 1.8 mg/dl.
boolean
C0201976 (UMLS CUI [1])
Cardiac ejection fraction
Item
9. cardiac ejection fraction > 40%.
boolean
C0232174 (UMLS CUI [1])
Carbon Monoxide Diffusing Capability Test
Item
10. dlco > 50% of the predicted value.
boolean
C1516251 (UMLS CUI [1])
Serum total bilirubin measurement
Item
11. serum bilirubin < 1.5 mg/dl.
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
12. sgpt < 3 x normal values.
boolean
C0201836 (UMLS CUI [1])
Sibling HLA Identical | Homologous Transplantation Refused
Item
13. patients with an hla identical sibling are eligible if they refuse allogeneic transplantation.
boolean
C0037047 (UMLS CUI [1,1])
C0019721 (UMLS CUI [1,2])
C0205280 (UMLS CUI [1,3])
C0040739 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Life-threatening infections Uncontrolled | Comorbidity Protocol Compliance Limited
Item
1. uncontrolled life-threatening infections or comorbid condition that could impair tolerance to the regimen.
boolean
C1859430 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
HIV Seropositivity
Item
2. hiv positivity.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
3. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Blast Phase
Item
4. blast crisis (>30% blasts in blood or marrow)
boolean
C0005699 (UMLS CUI [1])
Hepatitis B positive | Hepatitis C positive
Item
5. hepatitis b or c positivity.
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
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