ID

13255

Description

Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS; ODM derived from: https://clinicaltrials.gov/show/NCT00038831

Link

https://clinicaltrials.gov/show/NCT00038831

Keywords

Versions (1)
  1. 1/26/16 1/26/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 26, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00038831

English

Eligibility Acute Myelogenous Leukemia NCT00038831

1 forms  
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 always eligible if ejection fraction > 35, fev1, fvc, or dlco > 40%, abnormal lft's.
Description

patients are eligible if deemed ineligible for conventional high dose chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients must have recovered from previous grade iii-iv toxicity due to prior anti-neoplastic therapy (except alopecia).
Description

toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0013221
patients with the following disease categories will be eligible: 1. aml with induction failure, relapse or 2nd remission 2. mds with ipi int-2 or high-risk disease (appendix 4) or cmml 3. cml in accelerated phase or blast crisis 4. interferon or sti resistant cml not eligible for conventional stem cell transplant
Description

disease categories

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0023474
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

prior therapy

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0436307
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
Description

CD33 expression

Data type

boolean

Alias
UMLS CUI [1]
C0054952
patients must have an hla-compatible related donor (6/6 or 5/6 hla-match) capable of donating bone marrow or g-csf stimulated peripheral blood stem cells using aphereses techniques or a 6/6 hla matched unrelated bone marrow donor (serologic matching for class i, molecular matching for dr?1).
Description

donor for bone marrow or stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0013018
patients must have a ecog ps<2 (appendix 6), cr<2.0, bilirubin <2, and (sgpt) <3x normal
Description

ecog and laboratory values

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1520224
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. unrelated donors will be consented according to the national donor marrow registry policy
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
hiv disease
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
pregnancy and nursing
Description

pregnancy and lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active, uncontrolled cns leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00038831

1 forms
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])
patients are eligible if deemed ineligible for conventional 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 always eligible if ejection fraction > 35, fev1, fvc, or dlco > 40%, abnormal lft's.
boolean
C0392920 (UMLS CUI [1])
toxicity
Item
patients must have recovered from previous grade iii-iv toxicity due to prior anti-neoplastic therapy (except alopecia).
boolean
C0013221 (UMLS CUI [1])
disease categories
Item
patients with the following disease categories will be eligible: 1. aml with induction failure, relapse or 2nd remission 2. mds with ipi int-2 or high-risk disease (appendix 4) or cmml 3. cml in accelerated phase or blast crisis 4. interferon or sti resistant cml not eligible for conventional stem cell transplant
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C0023474 (UMLS CUI [3])
prior therapy
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])
C0436307 (UMLS CUI [2])
CD33 expression
Item
leukemia cells must express cell surface cd33 evaluated by flow cytometry in > 20% of leukemia cells.
boolean
C0054952 (UMLS CUI [1])
donor for bone marrow or stem cell transplant
Item
patients must have an hla-compatible related donor (6/6 or 5/6 hla-match) capable of donating bone marrow or g-csf stimulated peripheral blood stem cells using aphereses techniques or a 6/6 hla matched unrelated bone marrow donor (serologic matching for class i, molecular matching for dr?1).
boolean
C0013018 (UMLS CUI [1])
ecog and laboratory values
Item
patients must have a ecog ps<2 (appendix 6), cr<2.0, bilirubin <2, and (sgpt) <3x normal
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1520224 (UMLS CUI [4])
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. unrelated donors will be consented according to the national donor marrow registry policy
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
infection
Item
uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
hiv
Item
hiv disease
boolean
C0019682 (UMLS CUI [1])
pregnancy and lactation
Item
pregnancy and nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
cns leukemia
Item
active, uncontrolled cns leukemia
boolean
C1332884 (UMLS CUI [1])
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