ID

30215

Beskrivning

Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy; ODM derived from: https://clinicaltrials.gov/show/NCT00891137

Länk

https://clinicaltrials.gov/show/NCT00891137

Nyckelord

Versioner (1)
  1. 2018-05-19 2018-05-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT00891137

Engelsk

Eligibility Leukemia NCT00891137

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00891137
Criteria
Beskrivning

Criteria

undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:
Beskrivning

Umbilical Cord Blood Graft allogeneic | Cells per Kilogram Quantity Hematologic Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162371
UMLS CUI [1,2]
C1961139
UMLS CUI [1,3]
C1515895
UMLS CUI [2,1]
C3899697
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0376545
high risk acute myeloid leukemia (aml) in complete remission
Beskrivning

AML High risk In complete remission

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0677874
very high risk pediatric aml; patients <21 years eligible with <25% blasts in marrow after failed chemotherapy
Beskrivning

Pediatric acute myeloblastic leukemia High risk Very | Age | Blasts Bone marrow Percentage | Status post Chemotherapy failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220621
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0442824
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C1982687
UMLS CUI [3,2]
C0439165
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0392920
UMLS CUI [4,3]
C0231175
high risk acute lymphocytic leukemia (all) in complete remission
Beskrivning

Acute lymphocytic leukemia High risk In complete remission

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0677874
chronic myelogenous leukemia (cml), excluding refractory blast crisis
Beskrivning

Myeloid Leukemia, Chronic | Blast Phase refractory Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0023473
UMLS CUI [2,1]
C0005699
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0332196
myelodysplasia (mds) ipps int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
Beskrivning

Myelodysplasia IPSS | Refractory anemias | Pancytopenia Severe | Cytogenetic Analysis High risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026985
UMLS CUI [1,2]
C2827405
UMLS CUI [2]
C0002893
UMLS CUI [3,1]
C0030312
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0752095
UMLS CUI [4,2]
C0332167
chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), marginal zone b-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
Beskrivning

Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Marginal Zone B-Cell Lymphoma | Follicular Lymphoma progressed | Status post Prior Therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2]
C0855095
UMLS CUI [3]
C1367654
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C1272688
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1514463
UMLS CUI [5,3]
C1265611
lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
Beskrivning

Lymphoplasmacytic lymphoma | Mantle-cell lymphoma | Prolymphocytic Leukemia | Status post Therapeutic procedure Initial | Status post Complete remission | Status post Partial response

Datatyp

boolean

Alias
UMLS CUI [1]
C0024419
UMLS CUI [2]
C0334634
UMLS CUI [3]
C0023486
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205265
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0677874
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1521726
large cell non-hodgkin lymphoma (nhl) in second complete or partial remission (chemotherapy refractory large cell nhl not eligible)
Beskrivning

Non-Hodgkin Lymphoma Large Cell | Complete remission second | Partial response

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1513997
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0205436
UMLS CUI [3]
C1521726
lymphoblastic lymphoma, peripheral t cell lymphoma including angioimmunoblastic lymphoma, burkitt's lymphoma, and other high-grade nhl after initial therapy if stage iii/iv in complete or partial remission, or after progression if stage i/ii <1 year (chemotherapy refractory high-grade nhl not eligible)
Beskrivning

Lymphoblastic lymphoma | Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphoma | Burkitt Lymphoma | Non-Hodgkin Lymphoma High grade | Status post Therapeutic procedure Initial | Ann Arbor lymphoma staging system Complete remission | Ann Arbor lymphoma staging system Partial response | Ann Arbor lymphoma staging system Post Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C0079748
UMLS CUI [2]
C0079774
UMLS CUI [3]
C0020981
UMLS CUI [4]
C0006413
UMLS CUI [5,1]
C0024305
UMLS CUI [5,2]
C1962917
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0087111
UMLS CUI [6,3]
C0205265
UMLS CUI [7,1]
C0432516
UMLS CUI [7,2]
C0677874
UMLS CUI [8,1]
C0432516
UMLS CUI [8,2]
C1521726
UMLS CUI [9,1]
C0432516
UMLS CUI [9,2]
C0687676
UMLS CUI [9,3]
C0242656
multiple myeloma beyond 2nd partial remission
Beskrivning

Multiple Myeloma | Exception Partial response second

Datatyp

boolean

Alias
UMLS CUI [1]
C0026764
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1521726
UMLS CUI [2,3]
C0205436
preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
Beskrivning

Preparative Regimen | Cyclophosphamide | fludarabine | Whole-Body Irradiation

Datatyp

boolean

Alias
UMLS CUI [1]
C1882454
UMLS CUI [2]
C0010583
UMLS CUI [3]
C0059985
UMLS CUI [4]
C0043162
adequate organ function
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
symptomatic underlying pulmonary disease or requiring oxygen
Beskrivning

Lung disease Symptomatic | Requirement Oxygen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0030054
active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
hiv positive
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
pregnant or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Leukemia NCT00891137

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00891137
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Umbilical Cord Blood Graft allogeneic | Cells per Kilogram Quantity Hematologic Neoplasms
Item
undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:
boolean
C0162371 (UMLS CUI [1,1])
C1961139 (UMLS CUI [1,2])
C1515895 (UMLS CUI [1,3])
C3899697 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0376545 (UMLS CUI [2,3])
AML High risk In complete remission
Item
high risk acute myeloid leukemia (aml) in complete remission
boolean
C0023467 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
Pediatric acute myeloblastic leukemia High risk Very | Age | Blasts Bone marrow Percentage | Status post Chemotherapy failed
Item
very high risk pediatric aml; patients <21 years eligible with <25% blasts in marrow after failed chemotherapy
boolean
C0220621 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0442824 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C1982687 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Acute lymphocytic leukemia High risk In complete remission
Item
high risk acute lymphocytic leukemia (all) in complete remission
boolean
C0023449 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
Myeloid Leukemia, Chronic | Blast Phase refractory Excluded
Item
chronic myelogenous leukemia (cml), excluding refractory blast crisis
boolean
C0023473 (UMLS CUI [1])
C0005699 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Myelodysplasia IPSS | Refractory anemias | Pancytopenia Severe | Cytogenetic Analysis High risk
Item
myelodysplasia (mds) ipps int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
boolean
C0026985 (UMLS CUI [1,1])
C2827405 (UMLS CUI [1,2])
C0002893 (UMLS CUI [2])
C0030312 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0752095 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
Chronic Lymphocytic Leukemia | Small Lymphocytic Lymphoma | Marginal Zone B-Cell Lymphoma | Follicular Lymphoma progressed | Status post Prior Therapy Quantity
Item
chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), marginal zone b-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
boolean
C0023434 (UMLS CUI [1])
C0855095 (UMLS CUI [2])
C1367654 (UMLS CUI [3])
C0024301 (UMLS CUI [4,1])
C1272688 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Lymphoplasmacytic lymphoma | Mantle-cell lymphoma | Prolymphocytic Leukemia | Status post Therapeutic procedure Initial | Status post Complete remission | Status post Partial response
Item
lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
boolean
C0024419 (UMLS CUI [1])
C0334634 (UMLS CUI [2])
C0023486 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205265 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0677874 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C1521726 (UMLS CUI [6,2])
Non-Hodgkin Lymphoma Large Cell | Complete remission second | Partial response
Item
large cell non-hodgkin lymphoma (nhl) in second complete or partial remission (chemotherapy refractory large cell nhl not eligible)
boolean
C0024305 (UMLS CUI [1,1])
C1513997 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3])
Lymphoblastic lymphoma | Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphoma | Burkitt Lymphoma | Non-Hodgkin Lymphoma High grade | Status post Therapeutic procedure Initial | Ann Arbor lymphoma staging system Complete remission | Ann Arbor lymphoma staging system Partial response | Ann Arbor lymphoma staging system Post Disease Progression
Item
lymphoblastic lymphoma, peripheral t cell lymphoma including angioimmunoblastic lymphoma, burkitt's lymphoma, and other high-grade nhl after initial therapy if stage iii/iv in complete or partial remission, or after progression if stage i/ii <1 year (chemotherapy refractory high-grade nhl not eligible)
boolean
C0079748 (UMLS CUI [1])
C0079774 (UMLS CUI [2])
C0020981 (UMLS CUI [3])
C0006413 (UMLS CUI [4])
C0024305 (UMLS CUI [5,1])
C1962917 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C0087111 (UMLS CUI [6,2])
C0205265 (UMLS CUI [6,3])
C0432516 (UMLS CUI [7,1])
C0677874 (UMLS CUI [7,2])
C0432516 (UMLS CUI [8,1])
C1521726 (UMLS CUI [8,2])
C0432516 (UMLS CUI [9,1])
C0687676 (UMLS CUI [9,2])
C0242656 (UMLS CUI [9,3])
Multiple Myeloma | Exception Partial response second
Item
multiple myeloma beyond 2nd partial remission
boolean
C0026764 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1521726 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
Preparative Regimen | Cyclophosphamide | fludarabine | Whole-Body Irradiation
Item
preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
boolean
C1882454 (UMLS CUI [1])
C0010583 (UMLS CUI [2])
C0059985 (UMLS CUI [3])
C0043162 (UMLS CUI [4])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Lung disease Symptomatic | Requirement Oxygen
Item
symptomatic underlying pulmonary disease or requiring oxygen
boolean
C0024115 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0030054 (UMLS CUI [2,2])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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