ID

15610

Description

Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00038805

Link

https://clinicaltrials.gov/show/NCT00038805

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00038805

English

Eligibility Leukemia NCT00038805

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038805
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 12-75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. patients with refractory aml are eligible provided ejection fraction >= 35%; fev1, fvc, or dlco >= 40%; gpt < 3 x normal, direct bilirubin < 2.
Description

high dose chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1328050
UMLS CUI [1,2]
C1548635
patients must have recovered from previous grade iii-iv toxicity due to prior antineoplastic therapy (except alopecia).
Description

grade iii-iv toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0013221
patients with aml with induction failure, relapse or 2nd remission
Description

aml with induction failure

Data type

boolean

Alias
UMLS CUI [1]
C0023467
patients with mds with ipi int-2 or high-risk disease or cmml.
Description

mds with ipi int-2 or high-risk disease or cmml

Data type

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
patients with cml in accelerated phase or blast crisis
Description

cml in accelerated phase or blast crisis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023473
UMLS CUI [1,2]
C0457345
UMLS CUI [2,1]
C0023473
UMLS CUI [2,2]
C0005699
patients with all with induction failure, relapse or 2nd remission
Description

all with induction failure, relapse or 2nd remission

Data type

boolean

Alias
UMLS CUI [1]
C0023449
patients receiving prior bmt are eligible. if myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. if non-myeloablative therapy was used patients must be >30 days post-transplant.
Description

bmt

Data type

boolean

Alias
UMLS CUI [1]
C0005961
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
Description

express cell surface cd33

Data type

boolean

Alias
UMLS CUI [1]
C3491277
patients must have an hla identical related donor capable of donating g-csf stimulated peripheral blood stem cells using apheresis techniques. if patient has a contraindication to pbsc collection bone marrow can be used.
Description

hla identical related donor

Data type

boolean

Alias
UMLS CUI [1]
C0019633
patients must have a zubrod ps <2, cr <2.0, direct bilirubin <2, and transaminases sgpt <3x normal
Description

zubrod ps

Data type

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0201916
UMLS CUI [3]
C0201836
patients must have an estimated life expectancy > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patient and donor must sign informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no uncontrolled active infection
Description

uncontrolled active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
no hiv disease
Description

hiv disease

Data type

boolean

Alias
UMLS CUI [1]
C0019682
no pregnancy and no nursing
Description

pregnancy and nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no active, uncontrolled cns leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
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Similar models

Eligibility Leukemia NCT00038805

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00038805
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients 12-75 years of age
boolean
C0001779 (UMLS CUI [1])
high dose chemotherapy
Item
patients are eligible if deemed ineligible for conventional high dose chemotherapy programs because of concurrent medical conditions. patients with refractory aml are eligible provided ejection fraction >= 35%; fev1, fvc, or dlco >= 40%; gpt < 3 x normal, direct bilirubin < 2.
boolean
C1328050 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
grade iii-iv toxicity
Item
patients must have recovered from previous grade iii-iv toxicity due to prior antineoplastic therapy (except alopecia).
boolean
C0013221 (UMLS CUI [1])
aml with induction failure
Item
patients with aml with induction failure, relapse or 2nd remission
boolean
C0023467 (UMLS CUI [1])
mds with ipi int-2 or high-risk disease or cmml
Item
patients with mds with ipi int-2 or high-risk disease or cmml.
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
cml in accelerated phase or blast crisis
Item
patients with cml in accelerated phase or blast crisis
boolean
C0023473 (UMLS CUI [1,1])
C0457345 (UMLS CUI [1,2])
C0023473 (UMLS CUI [2,1])
C0005699 (UMLS CUI [2,2])
all with induction failure, relapse or 2nd remission
Item
patients with all with induction failure, relapse or 2nd remission
boolean
C0023449 (UMLS CUI [1])
bmt
Item
patients receiving prior bmt are eligible. if myeloablative chemoradiotherapy was used in the prior transplant patients must be >90 days from transplant. if non-myeloablative therapy was used patients must be >30 days post-transplant.
boolean
C0005961 (UMLS CUI [1])
express cell surface cd33
Item
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
boolean
C3491277 (UMLS CUI [1])
hla identical related donor
Item
patients must have an hla identical related donor capable of donating g-csf stimulated peripheral blood stem cells using apheresis techniques. if patient has a contraindication to pbsc collection bone marrow can be used.
boolean
C0019633 (UMLS CUI [1])
zubrod ps
Item
patients must have a zubrod ps <2, cr <2.0, direct bilirubin <2, and transaminases sgpt <3x normal
boolean
C3714786 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
life expectancy
Item
patients must have an estimated life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
patient and donor must sign informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
uncontrolled active infection
Item
no uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
hiv disease
Item
no hiv disease
boolean
C0019682 (UMLS CUI [1])
pregnancy and nursing
Item
no pregnancy and no nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cns leukemia
Item
no active, uncontrolled cns leukemia
boolean
C1332884 (UMLS CUI [1])
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