ID

41101

Beschreibung

IPI-145 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT02028039

Link

https://clinicaltrials.gov/show/NCT02028039

Stichworte

Versionen (1)
  1. 24.06.20 24.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT02028039

Englisch

Eligibility Leukemia NCT02028039

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02028039
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previously treated all (including burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. patients with all or b or t cell origin may be treated. patients in first relapse will be eligible regardless of the first remission duration. at least 10 patients in salvage 1-2 will be treated to assess anti-all response more precisely.
Beschreibung

Prior Therapy | Acute lymphocytic leukemia recurrent | Acute lymphocytic leukemia refractory | Burkitt Lymphoma | Adult Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C1504403
UMLS CUI [3]
C4049242
UMLS CUI [4]
C0006413
UMLS CUI [5]
C0278721
UMLS CUI [6]
C0279525
2. age 16 years or older. pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. zubrod performance status 0-3.
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
4. adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
Beschreibung

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0027651
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
5. male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. non-childbearing is defined as > 1 year postmenopausal or surgically sterilized).
Beschreibung

Females & males of reproductive potential Barrier Contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0004764
UMLS CUI [2]
C3873750
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0493327
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
Beschreibung

Heart Disease New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
2. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45% are excluded.
Beschreibung

Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
3. patients who receive other chemotherapy. patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (concurrent therapy for central nervous system [cns] prophylaxis or treatment for cns relapse is permitted). treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the principal investigator.
Beschreibung

Chemotherapy | Prior Therapy Discontinued | Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1514463
UMLS CUI [4,1]
C1115804
UMLS CUI [4,2]
C1516728
4. prior allogeneic stem cell transplant in previous 3 months.
Beschreibung

Allogeneic hematopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C4255274
5. peripheral lymphoblasts > 50 x 109/l.
Beschreibung

Lymphoblast count Peripheral blood

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1167770
UMLS CUI [1,2]
C0229664
6. pregnant and breast-feeding patients are excluded.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients with known hepatitis b or c are excluded.
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Leukemia NCT02028039

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02028039
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Prior Therapy | Acute lymphocytic leukemia recurrent | Acute lymphocytic leukemia refractory | Burkitt Lymphoma | Adult Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma
Item
1. previously treated all (including burkitt's lymphoma, lymphoblastic lymphoma) in relapse or primary refractory. patients with all or b or t cell origin may be treated. patients in first relapse will be eligible regardless of the first remission duration. at least 10 patients in salvage 1-2 will be treated to assess anti-all response more precisely.
boolean
C1514463 (UMLS CUI [1])
C1504403 (UMLS CUI [2])
C4049242 (UMLS CUI [3])
C0006413 (UMLS CUI [4])
C0278721 (UMLS CUI [5])
C0279525 (UMLS CUI [6])
Age
Item
2. age 16 years or older. pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. zubrod performance status 0-3.
boolean
C3714786 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Renal function | Creatinine measurement, serum
Item
4. adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0027651 (UMLS CUI [5,3])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Females & males of reproductive potential Barrier Contraception | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
5. male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. non-childbearing is defined as > 1 year postmenopausal or surgically sterilized).
boolean
C4034483 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C3873750 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0493327 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification
Item
1. patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
2. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45% are excluded.
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Chemotherapy | Prior Therapy Discontinued | Toxicity Due to Prior Therapy | Patient recovered CTCAE Grades
Item
3. patients who receive other chemotherapy. patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (concurrent therapy for central nervous system [cns] prophylaxis or treatment for cns relapse is permitted). treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the principal investigator.
boolean
C0392920 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Allogeneic hematopoietic stem cell transplant
Item
4. prior allogeneic stem cell transplant in previous 3 months.
boolean
C4255274 (UMLS CUI [1])
Lymphoblast count Peripheral blood
Item
5. peripheral lymphoblasts > 50 x 109/l.
boolean
C1167770 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
6. pregnant and breast-feeding patients are excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hepatitis B | Hepatitis C
Item
7. patients with known hepatitis b or c are excluded.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

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