ID

13959

Description

ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01478074

Link

https://clinicaltrials.gov/show/NCT01478074

Keywords

Versions (1)
  1. 3/20/16 3/20/16 -
Uploaded on

March 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT01478074

English

Eligibility Acute Myeloid Leukemia NCT01478074

1 forms  
Recipient inclusion criteria
Description

Recipient inclusion criteria

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)
Description

Recurrent adult acute myeloid leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0278780
For patients of cohorts 2 to 4, availability of a haploidentical family peripheral blood stem cell donor selected for best possible kir reactivity
Description

Haploidentical stem cell donor

Data type

boolean

Alias
UMLS CUI [1,1]
C3829897
UMLS CUI [1,2]
C0375877
Patient is between 2 and 59 years of age, inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Patient has recovered from cytotoxic agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0521108
UMLS CUI [1,2]
C0304497
Zubrod performance scale (refer to appendix c) ≤ 2 or lansky (refer to appendix d) > 60
Description

Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C1522275
Adequate renal function for adults and children
Description

for adults serum creatinine < 2 mg/dl for children serum creatinine < 2 mg/dl or < 2 times upper limit of normal (uln) for age (which ever is less) if abnormal creatinine level, 24h creatinine clearance > 60 ml/min/1.73m^2

Data type

boolean

Alias
UMLS CUI [1]
C0232805
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)
Description

Normal liver function

Data type

boolean

Alias
UMLS CUI [1]
C1848676
Pulmonary symptoms controlled by medication and pulse oximetry> 92% room air
Description

Pulmonary symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0277876
UMLS CUI [2]
C0034108
New york heart association classification < iii
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
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)
Description

Patient not pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0232973
Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Negative serology for human immunodeficiency virus (hiv)
Description

HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
Recipient exclusion criteria
Description

Recipient exclusion criteria

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

Investigational Therapies

Data type

boolean

Alias
UMLS CUI [1]
C0949266
Congestive heart failure < 6 months prior to screening
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
Unstable angina pectoris < 6 months prior to screening
Description

Unstable Angina

Data type

boolean

Alias
UMLS CUI [1]
C0002965
Myocardial infarction < 6 months prior to screening
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Donor inclusion criteria
Description

Donor inclusion criteria

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

Family Relationship

Data type

boolean

Alias
UMLS CUI [1]
C0015608
Hla-haploidentical to recipient (need not be re-tested if already performed previously, provided copies of the original results are available)
Description

Hla-haploidentical

Data type

boolean

Alias
UMLS CUI [1,1]
C0019721
UMLS CUI [1,2]
C3829897
Able and willing to undergo apheresis
Description

Apheresis of stem cells

Data type

boolean

Alias
UMLS CUI [1]
C0842379
Willing to donate blood for baseline chimerism assessment
Description

Willing to be donor of blood

Data type

boolean

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)
Description

Not pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0232973
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
Description

Clinical Trial Eligibility Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Donor must meet stem cell donor eligibility criteria as set forth in 21 cfr 1271 subpart c
Description

Stem cell donor eligibility criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0375877
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
Description

Predicted nk cell alloreactivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0022688
the hla haplotype (kir ligand) for the kir receptor in question is absent in the recipient
Description

KIR Ligand absent in recipient

Data type

boolean

Alias
UMLS CUI [1]
C3642144
The hla haplotype (kir ligand) for the kir receptor in question is present in the donor
Description

Kir ligand present in donor

Data type

boolean

Alias
UMLS CUI [1]
C3642144
Donor exclusion criteria
Description

Donor exclusion criteria

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

Active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Pregnant females
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Breast-feeding females
Description

Breast-feeding females

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT01478074

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
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])
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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