ID

22011

Description

Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00402558

Link

https://clinicaltrials.gov/show/NCT00402558

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndrome NCT00402558

English

Eligibility Myelodysplastic Syndrome NCT00402558

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with age </= 70 years with one of of the following: acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; myelodysplastic syndromes with intermediate or high risk ipss score; cml which has progressed to accelerated phase or blast crisis despite imatinib treatment
Description

Age | Acute Myelocytic Leukemia Post Remission First | Relapse First | Relapse Following | Disease remission second | Disease remission Greater Than second | Primary Induction Failure | MYELODYSPLASTIC SYNDROME International Prognostic Scoring System (IPSS) for Myelodysplastic Syndromes | Leukemia, Myeloid, Accelerated Phase | imatinib | Blast Crisis

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0544452
UMLS CUI [2,4]
C0205435
UMLS CUI [3,1]
C0035020
UMLS CUI [3,2]
C0205435
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C0332282
UMLS CUI [5,1]
C0544452
UMLS CUI [5,2]
C0205436
UMLS CUI [6,1]
C0544452
UMLS CUI [6,2]
C0439093
UMLS CUI [6,3]
C0205436
UMLS CUI [7]
C2347677
UMLS CUI [8,1]
C3463824
UMLS CUI [8,2]
C2827405
UMLS CUI [9]
C0023472
UMLS CUI [10]
C0935989
UMLS CUI [11]
C0005699
2. patients must have an hla matched (hla a, b, c, dr) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (recent large analyses of the national marrow donor program indicate that a mis-match at the dq locus has no adverse effect on outcome. the current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
Description

Donor Relative HLA Matched | Unrelated Donors HLA Matched | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR Antigens | Allogeneic transplantation Hematopoietic progenitor cell Peripheral blood | Blood Donation Willing | Mismatch HLA-DQ Antigens Adverse effects Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0080103
UMLS CUI [1,3]
C1548978
UMLS CUI [2,1]
C3179133
UMLS CUI [2,2]
C1548978
UMLS CUI [3]
C0019728
UMLS CUI [4]
C0019737
UMLS CUI [5]
C0019751
UMLS CUI [6]
C0019764
UMLS CUI [7,1]
C3511527
UMLS CUI [7,2]
C0229664
UMLS CUI [8,1]
C0005794
UMLS CUI [8,2]
C0600109
UMLS CUI [9,1]
C1881865
UMLS CUI [9,2]
C0019761
UMLS CUI [9,3]
C0879626
UMLS CUI [9,4]
C0332197
3. patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant kir genes and incompatibility with the recipient for hla c and bw antigens.
Description

Relative Haploidentical | KIR Genes | Recipient incompatible HLA-C Antigens | Recipient incompatible HLA-Bw antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C3829897
UMLS CUI [2,1]
C0665952
UMLS CUI [2,2]
C0017337
UMLS CUI [3,1]
C1709854
UMLS CUI [3,2]
C0427679
UMLS CUI [3,3]
C0019751
UMLS CUI [4,1]
C1709854
UMLS CUI [4,2]
C0427679
UMLS CUI [4,3]
C0312673
4. zubrod performance status </= 2.
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
5. left ventricular ejection fraction >/= 45%. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
Description

Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C0205318
6. no symptomatic pulmonary disease. forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) >/= 50% of expected, corrected for hemoglobin.
Description

Lung disease Symptomatic | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test | Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0748133
UMLS CUI [3]
C1287681
UMLS CUI [4]
C1516251
UMLS CUI [5]
C4054790
7. serum creatinine </= 1.8mg%.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
8. serum glutamate pyruvate transaminase (sgpt) </= 200 iu/ml unless related to patients malignancy.
Description

Alanine aminotransferase measurement | Alanine aminotransferase measurement Malignant Neoplasms Related

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2,1]
C0201836
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0439849
9. bilirubin </= 1.5 mg/dl (unless gilbert's syndrome).no evidence of chronic active hepatitis or cirrhosis. if positive hepatitis serology, discuss with study chairman and consider liver biopsy.
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
10. patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
Description

Informed Consent | Informed Consent Patient Representatives | Informed Consent parent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0030551
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
11. no known allergy to mouse proteins or monoclonal antibodies
Description

Hypersensitivity mouse protein | Hypersensitivity Monoclonal Antibodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1334805
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003250
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. the protocol pi is the final arbiter of eligibility.
Description

Communicable Disease Uncontrolled | Antimicrobial medicament | Absent response to treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0443071
UMLS CUI [3]
C0438286
2. pleural/pericardial effusion or ascites estimated to be >1l.
Description

Pleural effusion | Pericardial effusion | Ascites

Data type

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0031039
UMLS CUI [3]
C0003962
3. hiv-positive.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
4. pregnancy: positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
Description

Pregnancy | Childbearing Potential Beta HCG positive | Postmenopausal state Duration | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0813152
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [4]
C0015787
5. known allergy to mouse proteins.
Description

Hypersensitivity mouse protein

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1334805
6. patient has received other systemic chemotherapeutic drugs (including mylotarg) within 14 days prior to trial enrollment or has unresolved grade >1 toxicity from prior chemotherapy treatment. (hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and it chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (lmd), that is in remission prior to enrollment on this study).
Description

Antineoplastic Agents Systemic | Mylotarg | Chemotherapy | Toxicity Unresolved CTCAE Grades | hydroxyurea | Ara-C Low dose | Induction Therapy Refractory | intrathecal chemotherapy | Maintenance therapy Lumbar microdiscectomy Remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0876099
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0443342
UMLS CUI [4,3]
C1516728
UMLS CUI [5]
C0020402
UMLS CUI [6,1]
C0733521
UMLS CUI [6,2]
C0445550
UMLS CUI [7,1]
C0600558
UMLS CUI [7,2]
C0205269
UMLS CUI [8]
C1517560
UMLS CUI [9,1]
C0677908
UMLS CUI [9,2]
C0457629
UMLS CUI [9,3]
C0544452
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Similar models

Eligibility Myelodysplastic Syndrome NCT00402558

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Acute Myelocytic Leukemia Post Remission First | Relapse First | Relapse Following | Disease remission second | Disease remission Greater Than second | Primary Induction Failure | MYELODYSPLASTIC SYNDROME International Prognostic Scoring System (IPSS) for Myelodysplastic Syndromes | Leukemia, Myeloid, Accelerated Phase | imatinib | Blast Crisis
Item
1. patients with age </= 70 years with one of of the following: acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; myelodysplastic syndromes with intermediate or high risk ipss score; cml which has progressed to accelerated phase or blast crisis despite imatinib treatment
boolean
C0001779 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0544452 (UMLS CUI [2,3])
C0205435 (UMLS CUI [2,4])
C0035020 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C0035020 (UMLS CUI [4,1])
C0332282 (UMLS CUI [4,2])
C0544452 (UMLS CUI [5,1])
C0205436 (UMLS CUI [5,2])
C0544452 (UMLS CUI [6,1])
C0439093 (UMLS CUI [6,2])
C0205436 (UMLS CUI [6,3])
C2347677 (UMLS CUI [7])
C3463824 (UMLS CUI [8,1])
C2827405 (UMLS CUI [8,2])
C0023472 (UMLS CUI [9])
C0935989 (UMLS CUI [10])
C0005699 (UMLS CUI [11])
Donor Relative HLA Matched | Unrelated Donors HLA Matched | HLA-A Antigens | HLA-B Antigens | HLA-C Antigens | HLA-DR Antigens | Allogeneic transplantation Hematopoietic progenitor cell Peripheral blood | Blood Donation Willing | Mismatch HLA-DQ Antigens Adverse effects Absent
Item
2. patients must have an hla matched (hla a, b, c, dr) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (recent large analyses of the national marrow donor program indicate that a mis-match at the dq locus has no adverse effect on outcome. the current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
boolean
C0013018 (UMLS CUI [1,1])
C0080103 (UMLS CUI [1,2])
C1548978 (UMLS CUI [1,3])
C3179133 (UMLS CUI [2,1])
C1548978 (UMLS CUI [2,2])
C0019728 (UMLS CUI [3])
C0019737 (UMLS CUI [4])
C0019751 (UMLS CUI [5])
C0019764 (UMLS CUI [6])
C3511527 (UMLS CUI [7,1])
C0229664 (UMLS CUI [7,2])
C0005794 (UMLS CUI [8,1])
C0600109 (UMLS CUI [8,2])
C1881865 (UMLS CUI [9,1])
C0019761 (UMLS CUI [9,2])
C0879626 (UMLS CUI [9,3])
C0332197 (UMLS CUI [9,4])
Relative Haploidentical | KIR Genes | Recipient incompatible HLA-C Antigens | Recipient incompatible HLA-Bw antigen
Item
3. patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant kir genes and incompatibility with the recipient for hla c and bw antigens.
boolean
C0080103 (UMLS CUI [1,1])
C3829897 (UMLS CUI [1,2])
C0665952 (UMLS CUI [2,1])
C0017337 (UMLS CUI [2,2])
C1709854 (UMLS CUI [3,1])
C0427679 (UMLS CUI [3,2])
C0019751 (UMLS CUI [3,3])
C1709854 (UMLS CUI [4,1])
C0427679 (UMLS CUI [4,2])
C0312673 (UMLS CUI [4,3])
Zubrod Performance Status
Item
4. zubrod performance status </= 2.
boolean
C3714786 (UMLS CUI [1])
Left ventricular ejection fraction | Cardiac Arrhythmia Uncontrolled | Heart Disease Symptomatic Uncontrolled
Item
5. left ventricular ejection fraction >/= 45%. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
boolean
C0428772 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Lung disease Symptomatic | FEV1 | Forced vital capacity | Carbon Monoxide Diffusing Capability Test | Hemoglobin Corrected Diffusion Capacity of the Lung for Carbon Monoxide
Item
6. no symptomatic pulmonary disease. forced expiratory volume at one second (fev1), forced vital capacity (fvc) and diffusing capacity of lung for carbon monoxide (dlco) >/= 50% of expected, corrected for hemoglobin.
boolean
C0024115 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0748133 (UMLS CUI [2])
C1287681 (UMLS CUI [3])
C1516251 (UMLS CUI [4])
C4054790 (UMLS CUI [5])
Creatinine measurement, serum
Item
7. serum creatinine </= 1.8mg%.
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Alanine aminotransferase measurement Malignant Neoplasms Related
Item
8. serum glutamate pyruvate transaminase (sgpt) </= 200 iu/ml unless related to patients malignancy.
boolean
C0201836 (UMLS CUI [1])
C0201836 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Serum total bilirubin measurement
Item
9. bilirubin </= 1.5 mg/dl (unless gilbert's syndrome).no evidence of chronic active hepatitis or cirrhosis. if positive hepatitis serology, discuss with study chairman and consider liver biopsy.
boolean
C1278039 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representatives | Informed Consent parent | Informed Consent Guardian
Item
10. patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0030551 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Hypersensitivity mouse protein | Hypersensitivity Monoclonal Antibodies
Item
11. no known allergy to mouse proteins or monoclonal antibodies
boolean
C0020517 (UMLS CUI [1,1])
C1334805 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003250 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Uncontrolled | Antimicrobial medicament | Absent response to treatment
Item
1. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. the protocol pi is the final arbiter of eligibility.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0443071 (UMLS CUI [2])
C0438286 (UMLS CUI [3])
Pleural effusion | Pericardial effusion | Ascites
Item
2. pleural/pericardial effusion or ascites estimated to be >1l.
boolean
C0032227 (UMLS CUI [1])
C0031039 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
HIV Seropositivity
Item
3. hiv-positive.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Childbearing Potential Beta HCG positive | Postmenopausal state Duration | Female Sterilization
Item
4. pregnancy: positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0813152 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
Hypersensitivity mouse protein
Item
5. known allergy to mouse proteins.
boolean
C0020517 (UMLS CUI [1,1])
C1334805 (UMLS CUI [1,2])
Antineoplastic Agents Systemic | Mylotarg | Chemotherapy | Toxicity Unresolved CTCAE Grades | hydroxyurea | Ara-C Low dose | Induction Therapy Refractory | intrathecal chemotherapy | Maintenance therapy Lumbar microdiscectomy Remission
Item
6. patient has received other systemic chemotherapeutic drugs (including mylotarg) within 14 days prior to trial enrollment or has unresolved grade >1 toxicity from prior chemotherapy treatment. (hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and it chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (lmd), that is in remission prior to enrollment on this study).
boolean
C0003392 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0876099 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0443342 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
C0020402 (UMLS CUI [5])
C0733521 (UMLS CUI [6,1])
C0445550 (UMLS CUI [6,2])
C0600558 (UMLS CUI [7,1])
C0205269 (UMLS CUI [7,2])
C1517560 (UMLS CUI [8])
C0677908 (UMLS CUI [9,1])
C0457629 (UMLS CUI [9,2])
C0544452 (UMLS CUI [9,3])
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