ID

40702

Beskrivning

Busulfan, Cyclophosphamide, and Melphalan or Busulfan and Fludarabine Phosphate Before Donor Hematopoietic Cell Transplant in Treating Younger Patients With Juvenile Myelomonocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01824693

Länk

https://clinicaltrials.gov/show/NCT01824693

Nyckelord

Versioner (1)
  1. 2020-04-30 2020-04-30 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

Engelsk

Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a strong clinical suspicion of jmml, based on a modified category 1 of the revised diagnostic criteria; specifically, eligible patients must have all of the following:
Beskrivning

Suspicion Juvenile Myelomonocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242114
UMLS CUI [1,2]
C0349639
splenomegaly
Beskrivning

Splenomegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0038002
absolute monocyte count (amc) > 1000/ul
Beskrivning

Monocyte count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0200637
blasts in peripheral blood (pb)/bone marrow (bm) < 20%
Beskrivning

Blasts Peripheral blood Percentage | Blasts Bone Marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0368761
UMLS CUI [1,2]
C0229664
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0439165
for the 7-10% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least 2 of the following criteria:
Beskrivning

Patients Without Splenomegaly | Diagnostic criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0038002
UMLS CUI [2,1]
C0679228
UMLS CUI [2,2]
C1550543
circulating myeloid precursors
Beskrivning

Myeloid precursor cell Circulating

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1268007
UMLS CUI [1,2]
C0175630
white blood cell (wbc) > 10,000/ul
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
increased fetal hemoglobin (hgbf) for age
Beskrivning

Elevated fetal hemoglobin | Relationship Age

Datatyp

boolean

Alias
UMLS CUI [1]
C2751485
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0001779
sargramostim (gm-csf) hypersensitivity or, patients must have been previously diagnosed with jmml
Beskrivning

Hypersensitivity Sargramostim | Prior diagnosis Juvenile Myelomonocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0216231
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0349639
patients must be previously untreated with hct
Beskrivning

Hemopoietic stem cell transplant Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0472699
UMLS CUI [1,2]
C0332197
all patients and/or their parents or legal guardians must sign a written informed consent
Beskrivning

Informed Consent | Informed Consent Parent | Informed Consent Legal Guardians

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0023226
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
Beskrivning

Requirement Human studies Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0178693
UMLS CUI [1,3]
C1550543
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a known germline mutation of ptpn11 (noonan's syndrome) are not eligible
Beskrivning

Germ-Line Mutation PTPN11 | Noonan Syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206530
UMLS CUI [1,2]
C1335280
UMLS CUI [2]
C0028326
patients with a known history of nf1 (neurofibromatosis type 1) and either
Beskrivning

Neurofibromatosis Type

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162678
UMLS CUI [1,2]
C0332307
a history of a tumor of the central nervous system (astrocytoma or optic glioma), or
Beskrivning

Central Nervous System Neoplasms | Astrocytoma | Optic Nerve Glioma

Datatyp

boolean

Alias
UMLS CUI [1]
C0085136
UMLS CUI [2]
C0004114
UMLS CUI [3]
C0346326
a malignant peripheral nerve sheath tumor with a complete remission of < 1 year are not eligible
Beskrivning

Malignant Peripheral Nerve Sheath Tumor Complete remission Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0751690
UMLS CUI [1,2]
C0677874
UMLS CUI [1,3]
C0449238
human immunodeficiency virus (hiv) positive patients are not eligible
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Suspicion Juvenile Myelomonocytic Leukemia
Item
patients must have a strong clinical suspicion of jmml, based on a modified category 1 of the revised diagnostic criteria; specifically, eligible patients must have all of the following:
boolean
C0242114 (UMLS CUI [1,1])
C0349639 (UMLS CUI [1,2])
Splenomegaly
Item
splenomegaly
boolean
C0038002 (UMLS CUI [1])
Monocyte count procedure
Item
absolute monocyte count (amc) > 1000/ul
boolean
C0200637 (UMLS CUI [1])
Blasts Peripheral blood Percentage | Blasts Bone Marrow Percentage
Item
blasts in peripheral blood (pb)/bone marrow (bm) < 20%
boolean
C0368761 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0368761 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Patients Without Splenomegaly | Diagnostic criteria Fulfill
Item
for the 7-10% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least 2 of the following criteria:
boolean
C0030705 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0038002 (UMLS CUI [1,3])
C0679228 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Myeloid precursor cell Circulating
Item
circulating myeloid precursors
boolean
C1268007 (UMLS CUI [1,1])
C0175630 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
white blood cell (wbc) > 10,000/ul
boolean
C0023508 (UMLS CUI [1])
Elevated fetal hemoglobin | Relationship Age
Item
increased fetal hemoglobin (hgbf) for age
boolean
C2751485 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Hypersensitivity Sargramostim | Prior diagnosis Juvenile Myelomonocytic Leukemia
Item
sargramostim (gm-csf) hypersensitivity or, patients must have been previously diagnosed with jmml
boolean
C0020517 (UMLS CUI [1,1])
C0216231 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0349639 (UMLS CUI [2,2])
Hemopoietic stem cell transplant Absent
Item
patients must be previously untreated with hct
boolean
C0472699 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent | Informed Consent Parent | Informed Consent Legal Guardians
Item
all patients and/or their parents or legal guardians must sign a written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0023226 (UMLS CUI [3,2])
Requirement Human studies Fulfill
Item
all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
boolean
C1514873 (UMLS CUI [1,1])
C0178693 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Germ-Line Mutation PTPN11 | Noonan Syndrome
Item
patients with a known germline mutation of ptpn11 (noonan's syndrome) are not eligible
boolean
C0206530 (UMLS CUI [1,1])
C1335280 (UMLS CUI [1,2])
C0028326 (UMLS CUI [2])
Neurofibromatosis Type
Item
patients with a known history of nf1 (neurofibromatosis type 1) and either
boolean
C0162678 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Central Nervous System Neoplasms | Astrocytoma | Optic Nerve Glioma
Item
a history of a tumor of the central nervous system (astrocytoma or optic glioma), or
boolean
C0085136 (UMLS CUI [1])
C0004114 (UMLS CUI [2])
C0346326 (UMLS CUI [3])
Malignant Peripheral Nerve Sheath Tumor Complete remission Duration
Item
a malignant peripheral nerve sheath tumor with a complete remission of < 1 year are not eligible
boolean
C0751690 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
HIV Seropositivity
Item
human immunodeficiency virus (hiv) positive patients are not eligible
boolean
C0019699 (UMLS CUI [1])
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