ID

36843

Description

Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT02333162

Link

https://clinicaltrials.gov/show/NCT02333162

Keywords

  1. 6/15/19 6/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 15, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Previously Treated Myelodysplastic Syndrome NCT02333162

Eligibility Previously Treated Myelodysplastic Syndrome NCT02333162

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with the following diseases: acute myeloid leukemia (aml) and high risk myelodysplastic syndrome (mds) undergoing second allogeneic (allo)-stem cell transplant (sct) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (all), will be at the discretion of the investigators
Description

Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk | Allogeneic Stem Cell Transplantation second | Donor Same Recurrent disease | Donor Different Recurrent disease | Hematologic Neoplasms | Acute lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C4319571
UMLS CUI [3,1]
C2242529
UMLS CUI [3,2]
C0205436
UMLS CUI [4,1]
C0040288
UMLS CUI [4,2]
C0445247
UMLS CUI [4,3]
C0277556
UMLS CUI [5,1]
C0040288
UMLS CUI [5,2]
C1705242
UMLS CUI [5,3]
C0277556
UMLS CUI [6]
C0376545
UMLS CUI [7]
C0023449
karnofsky performance status of 70 or above
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy is not severely limited by concomitant illness
Description

Life Expectancy | Limitation Severe Absent

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0449295
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332197
adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (lvef) =< 40% or diffusion capacity of carbon monoxide (dlco) =< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
Description

Cardiac function | Pulmonary function | Left ventricular ejection fraction decreased | Percent Predicted DLCO | Evaluation Before Enrollment

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0231921
UMLS CUI [3]
C1096403
UMLS CUI [4]
C4054207
UMLS CUI [5,1]
C1261322
UMLS CUI [5,2]
C0332152
UMLS CUI [5,3]
C1516879
serum creatinine =<1.5 mg/dl or creatinine clearance > 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (pi)
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
serum bilirubin =< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the pi
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum glutamic oxaloacetic transaminase (sgpt) < 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the pi
Description

Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
no evidence of chronic active hepatitis or cirrhosis
Description

Chronic Hepatitis Absent | Chronic Liver Cirrhosis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0332197
human immunodeficiency virus (hiv)-negative
Description

HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
patient is not pregnant
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
patient or guardian able to sign informed consent
Description

Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
donor: since these patients already had first allo-sct; in the majority time, the same matched donor has been used for second allo-sct; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-sct; the donor could be matched related donors or matched unrelated donors from registry
Description

Donor | Donor Matched Same | Allogeneic Stem Cell Transplantation First | Allogeneic Stem Cell Transplantation second | Donors multiple | Donor Matched Alternative | Matched Related Donor | Matched Unrelated Donor

Data type

boolean

Alias
UMLS CUI [1]
C0040288
UMLS CUI [2,1]
C0040288
UMLS CUI [2,2]
C0150103
UMLS CUI [2,3]
C0445247
UMLS CUI [3,1]
C2242529
UMLS CUI [3,2]
C0205435
UMLS CUI [4,1]
C2242529
UMLS CUI [4,2]
C0205436
UMLS CUI [5,1]
C0040288
UMLS CUI [5,2]
C0439064
UMLS CUI [6,1]
C0040288
UMLS CUI [6,2]
C0150103
UMLS CUI [6,3]
C1523987
UMLS CUI [7]
C4330663
UMLS CUI [8]
C4318937
donor: if more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (sop):
Description

Donor | Matched Unrelated Donor Quantity | Selection further

Data type

boolean

Alias
UMLS CUI [1]
C0040288
UMLS CUI [2,1]
C4318937
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1707391
UMLS CUI [3,2]
C1524062
age of donor (18-24 > 25-34 > 35-44 > 45+)
Description

Age Donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0040288
sex of donor (male > female, nulliparous female > parous, multiparous female)
Description

Gender Donor | Gender Nulliparous | Gender Parous cervix | Gender Multiparity

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0040288
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0425979
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C2045006
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0026751
cytomegalovirus (cmv) status, if recipient is cmv seronegative (cmv- > cmv+
Description

Cytomegalovirus status | Recipient Cytomegalovirus Seronegative | Recipient Cytomegalovirus Seropositive

Data type

boolean

Alias
UMLS CUI [1]
C0582172
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0010825
UMLS CUI [2,3]
C0521144
UMLS CUI [3,1]
C1709854
UMLS CUI [3,2]
C0010825
UMLS CUI [3,3]
C0521143

Similar models

Eligibility Previously Treated Myelodysplastic Syndrome NCT02333162

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk | Allogeneic Stem Cell Transplantation second | Donor Same Recurrent disease | Donor Different Recurrent disease | Hematologic Neoplasms | Acute lymphocytic leukemia
Item
patients with the following diseases: acute myeloid leukemia (aml) and high risk myelodysplastic syndrome (mds) undergoing second allogeneic (allo)-stem cell transplant (sct) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (all), will be at the discretion of the investigators
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C4319571 (UMLS CUI [2,2])
C2242529 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
C0040288 (UMLS CUI [4,1])
C0445247 (UMLS CUI [4,2])
C0277556 (UMLS CUI [4,3])
C0040288 (UMLS CUI [5,1])
C1705242 (UMLS CUI [5,2])
C0277556 (UMLS CUI [5,3])
C0376545 (UMLS CUI [6])
C0023449 (UMLS CUI [7])
Karnofsky Performance Status
Item
karnofsky performance status of 70 or above
boolean
C0206065 (UMLS CUI [1])
Life Expectancy | Limitation Severe Absent
Item
life expectancy is not severely limited by concomitant illness
boolean
C0023671 (UMLS CUI [1])
C0449295 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cardiac function | Pulmonary function | Left ventricular ejection fraction decreased | Percent Predicted DLCO | Evaluation Before Enrollment
Item
adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (lvef) =< 40% or diffusion capacity of carbon monoxide (dlco) =< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
boolean
C0232164 (UMLS CUI [1])
C0231921 (UMLS CUI [2])
C1096403 (UMLS CUI [3])
C4054207 (UMLS CUI [4])
C1261322 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
C1516879 (UMLS CUI [5,3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine =<1.5 mg/dl or creatinine clearance > 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (pi)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum bilirubin =< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the pi
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
serum glutamic oxaloacetic transaminase (sgpt) < 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the pi
boolean
C0201899 (UMLS CUI [1])
Chronic Hepatitis Absent | Chronic Liver Cirrhosis Absent
Item
no evidence of chronic active hepatitis or cirrhosis
boolean
C0019189 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
HIV negative
Item
human immunodeficiency virus (hiv)-negative
boolean
C0481430 (UMLS CUI [1])
Pregnancy Absent
Item
patient is not pregnant
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent | Informed Consent Guardian
Item
patient or guardian able to sign informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Donor | Donor Matched Same | Allogeneic Stem Cell Transplantation First | Allogeneic Stem Cell Transplantation second | Donors multiple | Donor Matched Alternative | Matched Related Donor | Matched Unrelated Donor
Item
donor: since these patients already had first allo-sct; in the majority time, the same matched donor has been used for second allo-sct; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-sct; the donor could be matched related donors or matched unrelated donors from registry
boolean
C0040288 (UMLS CUI [1])
C0040288 (UMLS CUI [2,1])
C0150103 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
C2242529 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C2242529 (UMLS CUI [4,1])
C0205436 (UMLS CUI [4,2])
C0040288 (UMLS CUI [5,1])
C0439064 (UMLS CUI [5,2])
C0040288 (UMLS CUI [6,1])
C0150103 (UMLS CUI [6,2])
C1523987 (UMLS CUI [6,3])
C4330663 (UMLS CUI [7])
C4318937 (UMLS CUI [8])
Donor | Matched Unrelated Donor Quantity | Selection further
Item
donor: if more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (sop):
boolean
C0040288 (UMLS CUI [1])
C4318937 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1707391 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
Age Donor
Item
age of donor (18-24 > 25-34 > 35-44 > 45+)
boolean
C0001779 (UMLS CUI [1,1])
C0040288 (UMLS CUI [1,2])
Gender Donor | Gender Nulliparous | Gender Parous cervix | Gender Multiparity
Item
sex of donor (male > female, nulliparous female > parous, multiparous female)
boolean
C0079399 (UMLS CUI [1,1])
C0040288 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0425979 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C2045006 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0026751 (UMLS CUI [4,2])
Cytomegalovirus status | Recipient Cytomegalovirus Seronegative | Recipient Cytomegalovirus Seropositive
Item
cytomegalovirus (cmv) status, if recipient is cmv seronegative (cmv- > cmv+
boolean
C0582172 (UMLS CUI [1])
C1709854 (UMLS CUI [2,1])
C0010825 (UMLS CUI [2,2])
C0521144 (UMLS CUI [2,3])
C1709854 (UMLS CUI [3,1])
C0010825 (UMLS CUI [3,2])
C0521143 (UMLS CUI [3,3])

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