ID

14026

Descripción

Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT02250937

Link

https://clinicaltrials.gov/show/NCT02250937

Palabras clave

  1. 22/3/16 22/3/16 -
Subido en

22 de marzo de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT02250937

Eligibility Acute Myeloid Leukemia NCT02250937

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patients with acute myeloid leukemia or myelodysplastic syndrome not in complete remission (patients with disease detectable only by flow cytometry, cytogenetics, or molecular studies are eligible).
Descripción

AML, MDS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
Hla-identical sibling or 8/8 matched unrelated donor transplant.
Descripción

Hla-identical

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019721
UMLS CUI [2]
C0398534
Patients age 18 to 70 years old. Eligibility for pediatric patients will be determined in conjunction with an mdacc pediatrician. patients age 2-17 years old may be enrolled after at least 10 adults (ages 18-70 years old) have been assessed for safety at day 30, as defined in the statistical considerations section.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Direct bilirubin < 1 mg/dl and alt < 3 times upper limit of normal.
Descripción

Direct bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201916
Creatinine clearance > 50 ml/min (calculated creatinine clearance is permitted).
Descripción

Creatinine clearance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0812399
Adequate pulmonary function with fev1, fvc and dlco >/=50% of expected corrected for hemoglobin and/or volume. children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >/= 92% on room air.
Descripción

Pulmonary function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231921
Lvef >/= 40%.
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
Able to sign informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Negative beta hcg test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Descripción

Negative beta hcg

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0121166
Performance score of >/= 70 by karnofsky/lansky or ps 0 to 1 (ecog </=1).
Descripción

Performance score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2053069
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
Prior allogeneic or autologous transplantation.
Descripción

Allogeneic or autologous transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3899991
Uncontrolled infections.
Descripción

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3714514
HIV Seropositivity
Descripción

HIV positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019699

Similar models

Eligibility Acute Myeloid Leukemia NCT02250937

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
AML, MDS
Item
Patients with acute myeloid leukemia or myelodysplastic syndrome not in complete remission (patients with disease detectable only by flow cytometry, cytogenetics, or molecular studies are eligible).
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
Hla-identical
Item
Hla-identical sibling or 8/8 matched unrelated donor transplant.
boolean
C0019721 (UMLS CUI [1])
C0398534 (UMLS CUI [2])
Age
Item
Patients age 18 to 70 years old. Eligibility for pediatric patients will be determined in conjunction with an mdacc pediatrician. patients age 2-17 years old may be enrolled after at least 10 adults (ages 18-70 years old) have been assessed for safety at day 30, as defined in the statistical considerations section.
boolean
C0001779 (UMLS CUI [1])
Direct bilirubin
Item
Direct bilirubin < 1 mg/dl and alt < 3 times upper limit of normal.
boolean
C0201916 (UMLS CUI [1])
Creatinine clearance
Item
Creatinine clearance > 50 ml/min (calculated creatinine clearance is permitted).
boolean
C0812399 (UMLS CUI [1])
Pulmonary function
Item
Adequate pulmonary function with fev1, fvc and dlco >/=50% of expected corrected for hemoglobin and/or volume. children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of >/= 92% on room air.
boolean
C0231921 (UMLS CUI [1])
Left ventricular ejection fraction
Item
Lvef >/= 40%.
boolean
C0428772 (UMLS CUI [1])
Informed Consent
Item
Able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Negative beta hcg
Item
Negative beta hcg test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. women of child bearing potential must be willing to use an effective contraceptive measure while on study.
boolean
C0121166 (UMLS CUI [1])
Performance score
Item
Performance score of >/= 70 by karnofsky/lansky or ps 0 to 1 (ecog </=1).
boolean
C2053069 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic or autologous transplantation
Item
Prior allogeneic or autologous transplantation.
boolean
C3899991 (UMLS CUI [1])
Infection
Item
Uncontrolled infections.
boolean
C3714514 (UMLS CUI [1])
HIV positive
Item
HIV Seropositivity
boolean
C0019699 (UMLS CUI [1])

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