ID

24513

Description

Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00576979

Link

https://clinicaltrials.gov/show/NCT00576979

Keywords

Versions (1)
  1. 8/4/17 8/4/17 -
Uploaded on

August 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00576979

English

Eligibility Leukemia NCT00576979

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00576979
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission)
Description

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Remission First Absent | Remission second Absent | Remission Induction Therapy failed | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3,1]
C0544452
UMLS CUI [3,2]
C0205435
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0544452
UMLS CUI [4,2]
C0205436
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1514832
UMLS CUI [5,2]
C0231175
UMLS CUI [6]
C0277556
all candidates for this study must have an hla (a, b, c, dr) identical sibling who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; all abo blood group combinations of the donor/recipient are acceptable since even major abo compatibilities can be dealt with by various techniques
Description

Sibling HLA-A Identical | Sibling HLA-B Identical | Sibling HLA-C Identical | Sibling HLA-DR Identical | Sibling Donation of bone marrow Willing | Sibling Hematopoietic stem cells Primed | Unrelated Donors HLA Matched | ABO blood group Combination Donor Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0019728
UMLS CUI [1,3]
C0205280
UMLS CUI [2,1]
C0037047
UMLS CUI [2,2]
C0019737
UMLS CUI [2,3]
C0205280
UMLS CUI [3,1]
C0037047
UMLS CUI [3,2]
C0019751
UMLS CUI [3,3]
C0205280
UMLS CUI [4,1]
C0037047
UMLS CUI [4,2]
C0019764
UMLS CUI [4,3]
C0205280
UMLS CUI [5,1]
C0037047
UMLS CUI [5,2]
C1305211
UMLS CUI [5,3]
C0600109
UMLS CUI [6,1]
C0037047
UMLS CUI [6,2]
C0018956
UMLS CUI [6,3]
C0871133
UMLS CUI [7,1]
C3179133
UMLS CUI [7,2]
C1548978
UMLS CUI [8,1]
C0000778
UMLS CUI [8,2]
C0205195
UMLS CUI [8,3]
C0040288
UMLS CUI [8,4]
C1709854
prior therapy with vp-16, busulfan, and cytoxan is allowed
Description

VP-16 | Busulfan | Cytoxan

Data type

boolean

Alias
UMLS CUI [1]
C0733688
UMLS CUI [2]
C0006463
UMLS CUI [3]
C0699319
a cardiac exam with a electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (muga) or echocardiogram
Description

Changes Ischemic Electrocardiography | Cardiac Arrhythmia Electrocardiography | Cardiac ejection fraction Multiple gated acquisition scanning | Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C1623258
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0521317
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C0013516
patients must have a serum creatinine of less than or equal to 1.2 or creatinine clearance >= 80 ml/min
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
bilirubin of less than or equal to 1.5
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum glutamic oxaloacetic transaminase (sgot) less than 5 times the upper limit of normal
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
serum glutamic pyruvic transaminase (sgpt) less than 5 times the upper limit of normal
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
pulmonary functioning tests including diffusing capacity of carbon monoxide (dlco) will be performed; forced expiratory volume in one second (fev1) and dlco should be greater than 50% of the predicted normal value
Description

Pulmonary function tests | Carbon Monoxide Diffusing Capability Test | PULMONARY FUNCTION TEST FEV1

Data type

boolean

Alias
UMLS CUI [1]
C0024119
UMLS CUI [2]
C1516251
UMLS CUI [3]
C0748133
the time from the end last induction or reinduction attempt should be >= 14 days
Description

Remission Induction Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514832
signed informed consent form approved by the institutional review board (irb) is required
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
donor: any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
Description

Sibling Donors Histocompatibility Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0037047
UMLS CUI [1,2]
C0040288
UMLS CUI [1,3]
C0019627
UMLS CUI [1,4]
C1709854
donor: donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure
Description

Donors Excluded Due to Mental condition | Donors Excluded Due to Medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C3840291
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3843040
donor: donor should be able to donate peripheral blood stem cells or bone marrow
Description

Donors Peripheral blood stem cells Donation Ability | Donors Donation of bone marrow Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0040288
UMLS CUI [1,2]
C1518999
UMLS CUI [1,3]
C0680854
UMLS CUI [1,4]
C0085732
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C1305211
UMLS CUI [2,3]
C0085732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation therapy that would exclude the use of total-body irradiation
Description

Prior radiation therapy Excludes Whole-Body Irradiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0043162
patients who have undergone bone marrow transplantation previously and who have relapsed
Description

Bone Marrow Transplantation | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0277556
patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant
Description

Mental condition Allogeneic bone marrow transplantation Unacceptable | Medical condition Allogeneic bone marrow transplantation Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0149615
UMLS CUI [1,3]
C1883420
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0149615
UMLS CUI [2,3]
C1883420
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
electrocardiogram (ekg) showing ischemic changes or abnormal rhythm and/or an echocardiogram or muga scan showing abnormal wall motion or ejection fraction < 50%
Description

Changes Ischemic Electrocardiography | Cardiac Arrhythmia Electrocardiography | Wall motion Abnormal Echocardiography | Wall motion Abnormal Multiple gated acquisition scanning | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C1623258
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C1980023
UMLS CUI [3,2]
C0205161
UMLS CUI [3,3]
C0013516
UMLS CUI [4,1]
C1980023
UMLS CUI [4,2]
C0205161
UMLS CUI [4,3]
C0521317
UMLS CUI [5,1]
C0232174
UMLS CUI [5,2]
C0013516
UMLS CUI [6,1]
C0232174
UMLS CUI [6,2]
C0521317
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Similar models

Eligibility Leukemia NCT00576979

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00576979
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Remission First Absent | Remission second Absent | Remission Induction Therapy failed | Recurrent disease
Item
patients with acute lymphocytic leukemia or acute myelogenous leukemia who are not in first or second remission (i.e., after failing remission induction therapy or in relapse or beyond second remission)
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0544452 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0544452 (UMLS CUI [4,1])
C0205436 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1514832 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
C0277556 (UMLS CUI [6])
Sibling HLA-A Identical | Sibling HLA-B Identical | Sibling HLA-C Identical | Sibling HLA-DR Identical | Sibling Donation of bone marrow Willing | Sibling Hematopoietic stem cells Primed | Unrelated Donors HLA Matched | ABO blood group Combination Donor Recipient
Item
all candidates for this study must have an hla (a, b, c, dr) identical sibling who is willing to donate bone marrow or primed blood stem cells or a 10/10 allele matched unrelated donor; all abo blood group combinations of the donor/recipient are acceptable since even major abo compatibilities can be dealt with by various techniques
boolean
C0037047 (UMLS CUI [1,1])
C0019728 (UMLS CUI [1,2])
C0205280 (UMLS CUI [1,3])
C0037047 (UMLS CUI [2,1])
C0019737 (UMLS CUI [2,2])
C0205280 (UMLS CUI [2,3])
C0037047 (UMLS CUI [3,1])
C0019751 (UMLS CUI [3,2])
C0205280 (UMLS CUI [3,3])
C0037047 (UMLS CUI [4,1])
C0019764 (UMLS CUI [4,2])
C0205280 (UMLS CUI [4,3])
C0037047 (UMLS CUI [5,1])
C1305211 (UMLS CUI [5,2])
C0600109 (UMLS CUI [5,3])
C0037047 (UMLS CUI [6,1])
C0018956 (UMLS CUI [6,2])
C0871133 (UMLS CUI [6,3])
C3179133 (UMLS CUI [7,1])
C1548978 (UMLS CUI [7,2])
C0000778 (UMLS CUI [8,1])
C0205195 (UMLS CUI [8,2])
C0040288 (UMLS CUI [8,3])
C1709854 (UMLS CUI [8,4])
VP-16 | Busulfan | Cytoxan
Item
prior therapy with vp-16, busulfan, and cytoxan is allowed
boolean
C0733688 (UMLS CUI [1])
C0006463 (UMLS CUI [2])
C0699319 (UMLS CUI [3])
Changes Ischemic Electrocardiography | Cardiac Arrhythmia Electrocardiography | Cardiac ejection fraction Multiple gated acquisition scanning | Cardiac ejection fraction Echocardiography
Item
a cardiac exam with a electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (muga) or echocardiogram
boolean
C0392747 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0521317 (UMLS CUI [3,2])
C0232174 (UMLS CUI [4,1])
C0013516 (UMLS CUI [4,2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
patients must have a serum creatinine of less than or equal to 1.2 or creatinine clearance >= 80 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin of less than or equal to 1.5
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum glutamic oxaloacetic transaminase (sgot) less than 5 times the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
serum glutamic pyruvic transaminase (sgpt) less than 5 times the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Pulmonary function tests | Carbon Monoxide Diffusing Capability Test | PULMONARY FUNCTION TEST FEV1
Item
pulmonary functioning tests including diffusing capacity of carbon monoxide (dlco) will be performed; forced expiratory volume in one second (fev1) and dlco should be greater than 50% of the predicted normal value
boolean
C0024119 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
C0748133 (UMLS CUI [3])
Remission Induction Therapy
Item
the time from the end last induction or reinduction attempt should be >= 14 days
boolean
C1514832 (UMLS CUI [1])
Informed Consent
Item
signed informed consent form approved by the institutional review board (irb) is required
boolean
C0021430 (UMLS CUI [1])
Sibling Donors Histocompatibility Recipient
Item
donor: any sibling donors who are histocompatible with the prospective recipient will be considered a suitable donor
boolean
C0037047 (UMLS CUI [1,1])
C0040288 (UMLS CUI [1,2])
C0019627 (UMLS CUI [1,3])
C1709854 (UMLS CUI [1,4])
Donors Excluded Due to Mental condition | Donors Excluded Due to Medical condition
Item
donor: donors will be excluded if for psychological or medical reasons they are unable to tolerate the procedure
boolean
C0040288 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C3840291 (UMLS CUI [1,4])
C0040288 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3843040 (UMLS CUI [2,4])
Donors Peripheral blood stem cells Donation Ability | Donors Donation of bone marrow Ability
Item
donor: donor should be able to donate peripheral blood stem cells or bone marrow
boolean
C0040288 (UMLS CUI [1,1])
C1518999 (UMLS CUI [1,2])
C0680854 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C0040288 (UMLS CUI [2,1])
C1305211 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Excludes Whole-Body Irradiation
Item
prior radiation therapy that would exclude the use of total-body irradiation
boolean
C0279134 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0043162 (UMLS CUI [1,3])
Bone Marrow Transplantation | Recurrent disease
Item
patients who have undergone bone marrow transplantation previously and who have relapsed
boolean
C0005961 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Mental condition Allogeneic bone marrow transplantation Unacceptable | Medical condition Allogeneic bone marrow transplantation Unacceptable
Item
patients with psychological or medical condition that patients physician deems unacceptable to proceed to allogeneic bone marrow transplant
boolean
C3840291 (UMLS CUI [1,1])
C0149615 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0149615 (UMLS CUI [2,2])
C1883420 (UMLS CUI [2,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Changes Ischemic Electrocardiography | Cardiac Arrhythmia Electrocardiography | Wall motion Abnormal Echocardiography | Wall motion Abnormal Multiple gated acquisition scanning | Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning
Item
electrocardiogram (ekg) showing ischemic changes or abnormal rhythm and/or an echocardiogram or muga scan showing abnormal wall motion or ejection fraction < 50%
boolean
C0392747 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C1980023 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0013516 (UMLS CUI [3,3])
C1980023 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0521317 (UMLS CUI [4,3])
C0232174 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
C0232174 (UMLS CUI [6,1])
C0521317 (UMLS CUI [6,2])
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