Eligibility Acute Myeloid Leukemia NCT01478074

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StudyEvent: Eligibility
1. Eligibility Acute Myeloid Leukemia NCT01478074

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Recipient inclusion criteria

Item Group

Recipient inclusion criteria

Recurrent adult acute myeloid leukemia

Item

Patients with relapsed aml, including those with cns disease or previous hematopoietic stem cell transplantation, or primary refractory aml (primary aml that has failed remission to at least two cycles of induction therapy)

boolean

C0278780 (UMLS CUI [1])

Haploidentical stem cell donor

Item

For patients of cohorts 2 to 4, availability of a haploidentical family peripheral blood stem cell donor selected for best possible kir reactivity

boolean

C3829897 (UMLS CUI [1,1])
C0375877 (UMLS CUI [1,2])

Age

Item

Patient is between 2 and 59 years of age, inclusive

boolean

C0001779 (UMLS CUI [1])

Patient has recovered from cytotoxic agents

Item

Patient must have recovered from the treatment-related toxicities of prior cytotoxic agents received in the 4 weeks prior to beginning treatment on this protocol, with the exception of cytopenias resulting from persistent disease, and alopecia

boolean

C0521108 (UMLS CUI [1,1])
C0304497 (UMLS CUI [1,2])

Performance Status

Item

Zubrod performance scale (refer to appendix c) ≤ 2 or lansky (refer to appendix d) > 60

boolean

C3714786 (UMLS CUI [1])
C1522275 (UMLS CUI [2])

Normal renal function

Item

Adequate renal function for adults and children

boolean

C0232805 (UMLS CUI [1])

Normal liver function

Item

Adequate liver function, defined as: total bilirubin ≤ 2 mg/dl and sgpt (alt) ≤ 2.5 x uln for age (unless gilbert's disease or abnormal liver function due to primary disease)

boolean

C1848676 (UMLS CUI [1])

Pulmonary symptoms

Item

Pulmonary symptoms controlled by medication and pulse oximetry> 92% room air

boolean

C0277876 (UMLS CUI [1])
C0034108 (UMLS CUI [2])

New York Heart Association Classification

Item

New york heart association classification < iii

boolean

C1275491 (UMLS CUI [1])

Patient not pregnant

Item

Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)

boolean

C0232973 (UMLS CUI [1])

Contraceptive methods

Item

Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator

boolean

C0700589 (UMLS CUI [1])

HIV negative

Item

Negative serology for human immunodeficiency virus (hiv)

boolean

C0481430 (UMLS CUI [1])

Recipient exclusion criteria

Item Group

Recipient exclusion criteria

Investigational Therapies

Item

Investigational therapies in the 4 weeks prior to beginning treatment on this protocol

boolean

C0949266 (UMLS CUI [1])

Congestive heart failure

Item

Congestive heart failure < 6 months prior to screening

boolean

C0018802 (UMLS CUI [1])

Unstable Angina

Item

Unstable angina pectoris < 6 months prior to screening

boolean

C0002965 (UMLS CUI [1])

Myocardial Infarction

Item

Myocardial infarction < 6 months prior to screening

boolean

C0027051 (UMLS CUI [1])

Donor inclusion criteria

Item Group

Donor inclusion criteria

Family Relationship

Item

Related to recipient (sibling, parent, offspring, offspring of a sibling)

boolean

C0015608 (UMLS CUI [1])

Hla-haploidentical

Item

Hla-haploidentical to recipient (need not be re-tested if already performed previously, provided copies of the original results are available)

boolean

C0019721 (UMLS CUI [1,1])
C3829897 (UMLS CUI [1,2])

Apheresis of stem cells

Item

Able and willing to undergo apheresis

boolean

C0842379 (UMLS CUI [1])

Willing to be donor of blood

Item

Willing to donate blood for baseline chimerism assessment

boolean

Not pregnant

Item

Negative serum test to rule out pregnancy within two weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)

boolean

C0232973 (UMLS CUI [1])

Clinical Trial Eligibility Criteria

Item

Donor must meet institutional eligibility criteria for allogeneic blood stem cell donation including infectious disease screening panel (hepatitis b, hepatitis c, hiv, cmv, and west nile virus) and cbc, differential and platelet studies

boolean

C1516637 (UMLS CUI [1])

Stem cell donor eligibility criteria

Item

Donor must meet stem cell donor eligibility criteria as set forth in 21 cfr 1271 subpart c

boolean

C1516637 (UMLS CUI [1,1])
C0375877 (UMLS CUI [1,2])

Predicted nk cell alloreactivity

Item

8. the preferred donor will be selected as the most alloreactive of the available haploidentical related donors on the basis of predicted nk cell alloreactivity using recipient and donor hla type. if necessary, the best of equally alloreactive donors will be determined by donor kir type. nk alloreactivity is defined as o a kir gene is present on the donor nk cells for which

boolean

C0022688 (UMLS CUI [1,1])

KIR Ligand absent in recipient

Item

the hla haplotype (kir ligand) for the kir receptor in question is absent in the recipient

boolean

C3642144 (UMLS CUI [1])

Kir ligand present in donor

Item

The hla haplotype (kir ligand) for the kir receptor in question is present in the donor

boolean

C3642144 (UMLS CUI [1])

Donor exclusion criteria

Item Group

Donor exclusion criteria

Active infection

Item

Active infection (defined as on antimicrobial therapy and/or febrile)

boolean

C0009450 (UMLS CUI [1])

Pregnancy

Item

Pregnant females

boolean

C0032961 (UMLS CUI [1])

Breast-feeding females

Item

Breast-feeding females

boolean

C0006147 (UMLS CUI [1])

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Eligibility Acute Myeloid Leukemia NCT01478074