ID

13159

Description

Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML); ODM derived from: https://clinicaltrials.gov/show/NCT00074750

Link

https://clinicaltrials.gov/show/NCT00074750

Keywords

Versions (1)
  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00074750

English

Eligibility Acute Myelogenous Leukemia NCT00074750

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with refractory or relapsed aml ( marrow blasts > 20% ), must have failed induction therapy or have relapsed after cr duration < 6 months following induction therapy, untreated or refractory to salvage chemotherapy. relapsed aml patients with cr duration > 6 months or previously untreated patients refusing chemotherapy and not considered for treatments of higher priority are also eligible.
Description

refractory or relapsed aml

Data type

boolean

Alias
UMLS CUI [1]
C0023467
patients with chronic myelomonocytic leukemia (cmml) who failed at least one course of chemo- or biological therapy( including trial of erythropoietin), or patients with relapsed cmml. previously untreated cmml patients with hb < or = 12 g / dl, not eligible for protocols of higher priority or not wishing to receive chemotherapy.
Description

chronic myelomonocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023480
patients must have an ecog performance status of < 2.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have wbc count < 10,000/ml prior to initiating the treatment. the wbc count must be stabilized below this level for at least three days by leukopheresis or hydroxyurea. hydroxyurea must be discontinued one day prior to initiation of dt388gmcsf treatment.
Description

wbc count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
patients must have creatinine < 1.6 times uln: bilirubin <1.6 times uln; sgpt < 2.6 x uln; albumin > 3 gm/dl; adequate cardiac function (ef >44%), oxygen saturation > 92% without exogenous oxygen administered.
Description

organ parameters

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201838
UMLS CUI [5]
C0232174
UMLS CUI [6]
C0523807
patients must be willing to be treated at m d anderson cancer center.
Description

patients must be willing to be treated at m d anderson cancer center.

Data type

boolean

women of childbearing potential and men must agree to practice contraception using approved methods.
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
no chemotherapy except hydroxyurea 2 weeks prior to entering the study and recovered from previous toxicity.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients must be > 17 years old.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with serious concurrent medical problems. patients with proven bacterial infections are not eligible until the resolution of the infection (patient afebrile who completed antibacterial therapy, not on steroids). patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and fever does not exceed 38c for at least 2 days.
Description

infections

Data type

boolean

Alias
UMLS CUI [1]
C0009450
inability to give informed consent because of psychiatric problems or other serious medical problems.
Description

inability to give informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
pregnant or nursing women.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with documented cns leukemia or leukemia with cns symptoms.
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
patients who have had a myocardial infarction within the past six months.
Description

myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
patients with severe penicillin allergy (anaphylaxis).
Description

penicillin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0030840
not fully recovered from toxic effects of prior chemotherapy or radiation therapy.
Description

toxic effects of chemotherapy or radiation

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
patients who are on corticosteroid treatment for any medical condition.
Description

corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0001617
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00074750

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
refractory or relapsed aml
Item
patients with refractory or relapsed aml ( marrow blasts > 20% ), must have failed induction therapy or have relapsed after cr duration < 6 months following induction therapy, untreated or refractory to salvage chemotherapy. relapsed aml patients with cr duration > 6 months or previously untreated patients refusing chemotherapy and not considered for treatments of higher priority are also eligible.
boolean
C0023467 (UMLS CUI [1])
chronic myelomonocytic leukemia
Item
patients with chronic myelomonocytic leukemia (cmml) who failed at least one course of chemo- or biological therapy( including trial of erythropoietin), or patients with relapsed cmml. previously untreated cmml patients with hb < or = 12 g / dl, not eligible for protocols of higher priority or not wishing to receive chemotherapy.
boolean
C0023480 (UMLS CUI [1])
ecog performance status
Item
patients must have an ecog performance status of < 2.
boolean
C1520224 (UMLS CUI [1])
wbc count
Item
patients must have wbc count < 10,000/ml prior to initiating the treatment. the wbc count must be stabilized below this level for at least three days by leukopheresis or hydroxyurea. hydroxyurea must be discontinued one day prior to initiation of dt388gmcsf treatment.
boolean
C0023508 (UMLS CUI [1])
organ parameters
Item
patients must have creatinine < 1.6 times uln: bilirubin <1.6 times uln; sgpt < 2.6 x uln; albumin > 3 gm/dl; adequate cardiac function (ef >44%), oxygen saturation > 92% without exogenous oxygen administered.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C0523807 (UMLS CUI [6])
patients must be willing to be treated at m d anderson cancer center.
Item
patients must be willing to be treated at m d anderson cancer center.
boolean
contraception
Item
women of childbearing potential and men must agree to practice contraception using approved methods.
boolean
C0700589 (UMLS CUI [1])
chemotherapy
Item
no chemotherapy except hydroxyurea 2 weeks prior to entering the study and recovered from previous toxicity.
boolean
C0392920 (UMLS CUI [1])
age
Item
patients must be > 17 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infections
Item
patients with serious concurrent medical problems. patients with proven bacterial infections are not eligible until the resolution of the infection (patient afebrile who completed antibacterial therapy, not on steroids). patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and fever does not exceed 38c for at least 2 days.
boolean
C0009450 (UMLS CUI [1])
inability to give informed consent
Item
inability to give informed consent because of psychiatric problems or other serious medical problems.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
pregnancy or lactation
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cns leukemia
Item
patients with documented cns leukemia or leukemia with cns symptoms.
boolean
C1332884 (UMLS CUI [1])
myocardial infarction
Item
patients who have had a myocardial infarction within the past six months.
boolean
C0027051 (UMLS CUI [1])
penicillin allergy
Item
patients with severe penicillin allergy (anaphylaxis).
boolean
C0020517 (UMLS CUI [1,1])
C0030840 (UMLS CUI [1,2])
toxic effects of chemotherapy or radiation
Item
not fully recovered from toxic effects of prior chemotherapy or radiation therapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
corticosteroids
Item
patients who are on corticosteroid treatment for any medical condition.
boolean
C0001617 (UMLS CUI [1])
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