ID

11838

Description

Study of Palbociclib in MLL-rearranged Acute Leukemias; ODM derived from: http://clinicaltrials.gov/show/NCT02310243

Link

http://clinicaltrials.gov/show/NCT02310243

Keywords

Versions (2)
  1. 8/6/15 8/6/15 - Julian Varghese
  2. 8/6/15 8/6/15 - Julian Varghese
Uploaded on

August 6, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia DRKS00008195 NCT02310243

English

Eligibility Acute Myeloid Leukemia NCT02310243

1 forms  
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02310243
    1. Eligibility Acute Myeloid Leukemia NCT02310243
Inclusion Criteria
Description

Inclusion Criteria

patients with confirmed diagnosis of acute leukemia with mll rearrangement according to the 2008 who classification
Description

patients with confirmed diagnosis of acute leukemia with mll rearrangement according to the 2008 who classification

Data type

boolean

Alias
UMLS CUI [1]
C2698308
patients with mll-rearranged leukemia who are refractory to standard induction therapy and not immediate candidates for allogeneic hsct (bridge to transplant is allowed)
Description

patients with mll-rearranged leukemia who are refractory to standard induction therapy and not immediate candidates for allogeneic hsct (bridge to transplant is allowed)

Data type

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C3179010
UMLS CUI [2,1]
C0013893
UMLS CUI [2,2]
C1705576
patients with mll-rearranged leukemia who relapsed after standard first-line treatment and are not immediate candidates for allogeneic hsct (bridge to transplant is allowed)
Description

patients with mll-rearranged leukemia who relapsed after standard first-line treatment and are not immediate candidates for allogeneic hsct (bridge to transplant is allowed)

Data type

boolean

Alias
UMLS CUI [1,1]
C2698308
UMLS CUI [1,2]
C0035020
UMLS CUI [2,1]
C0013893
UMLS CUI [2,2]
C1705576
patients with newly diagnosed mll-rearranged leukemia who are not eligible for intensive first-line therapy
Description

patients with newly diagnosed mll-rearranged leukemia who are not eligible for intensive first-line therapy

Data type

boolean

genetic assessment in the amlsg central laboratory
Description

genetic assessment in the amlsg central laboratory

Data type

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1880016
age ≥ 18 years, no upper age limit
Description

age ≥ 18 years, no upper age limit

Data type

boolean

Alias
UMLS CUI [1]
C0001779
who performance status of ≤ 2
Description

who performance status of ≤ 2

Data type

boolean

Alias
UMLS CUI [1]
C1298650
no prior chemotherapy two weeks before study entry except hydroxyurea to control hyperleukocytosis
Description

no prior chemotherapy two weeks before study entry except hydroxyurea to control hyperleukocytosis

Data type

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C0020402
non-pregnant and non-nursing. women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 miu/ml within 72 hours prior to registration (wocbp is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months).
Description

non-pregnant and non-nursing. women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 miu/ml within 72 hours prior to registration (wocbp is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months).

Data type

boolean

Alias
UMLS CUI [1]
C0430064
UMLS CUI [2]
C0006147
female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for three months after the last dose of therapy.
Description

female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for three months after the last dose of therapy.

Data type

boolean

Alias
UMLS CUI [1]
C0420837
women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (iud, tubal ligation, or partner's vasectomy). hormonal contraception is an inadequate method of birth control.
Description

women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (iud, tubal ligation, or partner's vasectomy). hormonal contraception is an inadequate method of birth control.

Data type

boolean

Alias
UMLS CUI [1]
C0420837
men must agree not to father a child and must use a latex condom during any sexual contact with wocbp while receiving therapy and for three months after therapy is stopped, even if they have undergone successful vasectomy.
Description

men must agree not to father a child and must use a latex condom during any sexual contact with wocbp while receiving therapy and for three months after therapy is stopped, even if they have undergone successful vasectomy.

Data type

boolean

Alias
UMLS CUI [1]
C0420837
signed written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

prior treatment with palbociclib
Description

prior treatment with palbociclib

Data type

boolean

Alias
UMLS CUI [1]
C3853822
performance status > 2 according to who criteria
Description

performance status > 2 according to who criteria

Data type

boolean

Alias
UMLS CUI [1]
C1298650
organ insufficiency: creatinine > 1.5 x upper normal serum level; bilirubin, ast, or ap > 2.5 x upper normal serum level; heart failure nyha iii/iv; uncontrolled hypertension; unstable angina; serious cardiac arrhythmia; severe obstructive or restrictive ventilation disorder
Description

organ insufficiency: creatinine > 1.5 x upper normal serum level; bilirubin, ast, or ap > 2.5 x upper normal serum level; heart failure nyha iii/iv; uncontrolled hypertension; unstable angina; serious cardiac arrhythmia; severe obstructive or restrictive ventilation disorder

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1275491
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0002965
UMLS CUI [8,1]
C0205082
UMLS CUI [8,2]
C0003811
uncontrolled infection
Description

uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0205318
UMLS CUI [1,2]
C0009450
patients with a "currently active" second malignancy other than non-melanoma skin cancer. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
Description

patients with a "currently active" second malignancy other than non-melanoma skin cancer. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
severe neurologic or psychiatric disorder interfering with ability of giving informed consent
Description

severe neurologic or psychiatric disorder interfering with ability of giving informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
known or suspected active alcohol or drug abuse
Description

known or suspected active alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
known positivity for hiv, active hav, hbv, or hcv infection
Description

known positivity for hiv, active hav, hbv, or hcv infection

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0850487
UMLS CUI [3]
C0744837
UMLS CUI [4]
C0850489
bleeding disorder unrelated to leukemia
Description

bleeding disorder unrelated to leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0005779
uncontrolled cns involvement (treatment for cns-involvement prior to inclusion is allowed)
Description

uncontrolled cns involvement (treatment for cns-involvement prior to inclusion is allowed)

Data type

boolean

Alias
UMLS CUI [1]
C0449389
qtc > 470 msec (based on the mean value of triplicate ecgs), family or personal history of long or short qt syndrome, brugada syndrome, or known history of qtc prolongation or torsade de pointes
Description

qtc > 470 msec (based on the mean value of triplicate ecgs), family or personal history of long or short qt syndrome, brugada syndrome, or known history of qtc prolongation or torsade de pointes

Data type

boolean

Alias
UMLS CUI [1]
C0489625
UMLS CUI [2]
C0023976
UMLS CUI [3]
C2348199
UMLS CUI [4]
C0855333
UMLS CUI [5]
C0040479
uncontrolled electrolyte disorders that can aggravate the effects of a qtc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
Description

uncontrolled electrolyte disorders that can aggravate the effects of a qtc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)

Data type

boolean

Alias
UMLS CUI [1]
C1704431
no consent for registration, storage, and processing of individual disease characteristics, information on the course of the disease, and information obtained from the family physician and/or other physicians involved in the treatment of the patient about study participation
Description

no consent for registration, storage, and processing of individual disease characteristics, information on the course of the disease, and information obtained from the family physician and/or other physicians involved in the treatment of the patient about study participation

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no consent for biobanking
Description

no consent for biobanking

Data type

boolean

Alias
UMLS CUI [1,1]
C1519671
UMLS CUI [1,2]
C0021430
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Similar models

Eligibility Acute Myeloid Leukemia NCT02310243

1 forms
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02310243
    1. Eligibility Acute Myeloid Leukemia NCT02310243
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
B Acute Lymphoblastic Leukemia with t(v;11q23); MLL Rearranged
Item
patients with confirmed diagnosis of acute leukemia with mll rearrangement according to the 2008 who classification
boolean
C2698308 (UMLS CUI [1])
Unresponsive to Treatment; Induction Chemotherapy | Eligibility Determination; Allogeneic Hematopoietic Stem Cell Transplantation
Item
patients with mll-rearranged leukemia who are refractory to standard induction therapy and not immediate candidates for allogeneic hsct (bridge to transplant is allowed)
boolean
C0205269 (UMLS CUI [1,1])
C3179010 (UMLS CUI [1,2])
C0013893 (UMLS CUI [2,1])
C1705576 (UMLS CUI [2,2])
B Acute Lymphoblastic Leukemia with t(v;11q23); MLL Rearranged; Relapse | Eligibility Determination; Allogeneic Hematopoietic Stem Cell Transplantation
Item
patients with mll-rearranged leukemia who relapsed after standard first-line treatment and are not immediate candidates for allogeneic hsct (bridge to transplant is allowed)
boolean
C2698308 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0013893 (UMLS CUI [2,1])
C1705576 (UMLS CUI [2,2])
Mll-rearranged leukemia who are not eligible for intensive first-line therapy
Item
patients with newly diagnosed mll-rearranged leukemia who are not eligible for intensive first-line therapy
boolean
Assessed; Central Laboratory
Item
genetic assessment in the amlsg central laboratory
boolean
C1516048 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
age
Item
age ≥ 18 years, no upper age limit
boolean
C0001779 (UMLS CUI [1])
WHO performance status
Item
who performance status of ≤ 2
boolean
C1298650 (UMLS CUI [1])
Chemotherapy | hydroxyurea
Item
no prior chemotherapy two weeks before study entry except hydroxyurea to control hyperleukocytosis
boolean
C3665472 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
serum pregnancy test | Breast Feeding
Item
non-pregnant and non-nursing. women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 miu/ml within 72 hours prior to registration (wocbp is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months).
boolean
C0430064 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraception status
Item
female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for three months after the last dose of therapy.
boolean
C0420837 (UMLS CUI [1])
Contraception status
Item
women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (iud, tubal ligation, or partner's vasectomy). hormonal contraception is an inadequate method of birth control.
boolean
C0420837 (UMLS CUI [1])
Contraception status
Item
men must agree not to father a child and must use a latex condom during any sexual contact with wocbp while receiving therapy and for three months after therapy is stopped, even if they have undergone successful vasectomy.
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
prior treatment with palbociclib
Item
prior treatment with palbociclib
boolean
C3853822 (UMLS CUI [1])
WHO performance status scale
Item
performance status > 2 according to who criteria
boolean
C1298650 (UMLS CUI [1])
Creatinine measurement, serum (procedure) | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement | New York Heart Association Classification | Uncontrolled hypertension | Angina, Unstable | Severe (severity modifier); Cardiac Arrhythmia
Item
organ insufficiency: creatinine > 1.5 x upper normal serum level; bilirubin, ast, or ap > 2.5 x upper normal serum level; heart failure nyha iii/iv; uncontrolled hypertension; unstable angina; serious cardiac arrhythmia; severe obstructive or restrictive ventilation disorder
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1275491 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0205082 (UMLS CUI [8,1])
C0003811 (UMLS CUI [8,2])
Uncontrolled; Communicable Diseases
Item
uncontrolled infection
boolean
C0205318 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Malignant Neoplasms
Item
patients with a "currently active" second malignancy other than non-melanoma skin cancer. patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
boolean
C0006826 (UMLS CUI [1])
psychiatric disorder; neurologic; severe informed consent;
Item
severe neurologic or psychiatric disorder interfering with ability of giving informed consent
boolean
C0021430 (UMLS CUI [1])
Drug abuse | Alcohol abuse
Item
known or suspected active alcohol or drug abuse
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
HIV Seropositivity | hepatitis A serology test | hepatitis b serology | hepatitis C serology test
Item
known positivity for hiv, active hav, hbv, or hcv infection
boolean
C0019699 (UMLS CUI [1])
C0850487 (UMLS CUI [2])
C0744837 (UMLS CUI [3])
C0850489 (UMLS CUI [4])
Blood Coagulation Disorders
Item
bleeding disorder unrelated to leukemia
boolean
C0005779 (UMLS CUI [1])
CNS involvement status
Item
uncontrolled cns involvement (treatment for cns-involvement prior to inclusion is allowed)
boolean
C0449389 (UMLS CUI [1])
qtc interval | Long QT Syndrome | Short Qt Syndrome | Electrocardiogram QT corrected interval prolonged | Torsades de Pointes
Item
qtc > 470 msec (based on the mean value of triplicate ecgs), family or personal history of long or short qt syndrome, brugada syndrome, or known history of qtc prolongation or torsade de pointes
boolean
C0489625 (UMLS CUI [1])
C0023976 (UMLS CUI [2])
C2348199 (UMLS CUI [3])
C0855333 (UMLS CUI [4])
C0040479 (UMLS CUI [5])
Disorder of electrolytes
Item
uncontrolled electrolyte disorders that can aggravate the effects of a qtc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
boolean
C1704431 (UMLS CUI [1])
Informed Consent
Item
no consent for registration, storage, and processing of individual disease characteristics, information on the course of the disease, and information obtained from the family physician and/or other physicians involved in the treatment of the patient about study participation
boolean
C0021430 (UMLS CUI [1])
Cancer Biobank; Informed Consent
Item
no consent for biobanking
boolean
C1519671 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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