ID

40702

Description

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

Link

https://clinicaltrials.gov/show/NCT01824693

Keywords

Versions (1)
  1. 4/30/20 4/30/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

English

Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

1 forms  
Inclusion Criteria
Description

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:
Description

Suspicion Juvenile Myelomonocytic Leukemia

Data type

boolean

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

Splenomegaly

Data type

boolean

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

Monocyte count procedure

Data type

boolean

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

Blasts Peripheral blood Percentage | Blasts Bone Marrow Percentage

Data type

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:
Description

Patients Without Splenomegaly | Diagnostic criteria Fulfill

Data type

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
Description

Myeloid precursor cell Circulating

Data type

boolean

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

White Blood Cell Count procedure

Data type

boolean

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

Elevated fetal hemoglobin | Relationship Age

Data type

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
Description

Hypersensitivity Sargramostim | Prior diagnosis Juvenile Myelomonocytic Leukemia

Data type

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
Description

Hemopoietic stem cell transplant Absent

Data type

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
Description

Informed Consent | Informed Consent Parent | Informed Consent Legal Guardians

Data type

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
Description

Requirement Human studies Fulfill

Data type

boolean

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

Exclusion Criteria

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

Germ-Line Mutation PTPN11 | Noonan Syndrome

Data type

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
Description

Neurofibromatosis Type

Data type

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
Description

Central Nervous System Neoplasms | Astrocytoma | Optic Nerve Glioma

Data type

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
Description

Malignant Peripheral Nerve Sheath Tumor Complete remission Duration

Data type

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
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Juvenile Myelomonocytic Leukemia NCT01824693

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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