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])