ID

14567

Beschrijving

Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01904643

Link

https://clinicaltrials.gov/show/NCT01904643

Trefwoorden

Versies (1)
  1. 21-04-16 21-04-16 -
Geüploaded op

21 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

Engels

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients eligible include those with diagnosis of aml other than acute promyelocytic leukemia by world health organization (who) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy
Beschrijving

aml

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
eastern cooperative oncology group (ecog) performance status 0-2
Beschrijving

eastern cooperative oncology group (ecog)

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine =< 1.5 mg/dl; if serum creatinine > 1.5 mg/dl, then the estimated glomerular filtrate rate (gfr) must be > 60ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation
Beschrijving

serum creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is considered to be secondary to gilbert's syndrome, hemolysis, or hepatic infiltration by aml
Beschrijving

serum bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
aspartate transaminase (ast)/alanine transaminase (alt) =< 2.5 x uln
Beschrijving

aspartate transaminase

Datatype

boolean

Alias
UMLS CUI [1]
C0004002
alkaline phosphatase =< 2.5 x uln
Beschrijving

alkaline phosphatase

Datatype

boolean

Alias
UMLS CUI [1]
C0201850
all study participants must be registered into the mandatory revlimid assistance (revassist) program, and be willing and able to comply with the requirements of revassist
Beschrijving

Revlimid

Datatype

boolean

Alias
UMLS CUI [1]
C1135145
females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revassist) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide; fcbp must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy
Beschrijving

negative serum or urine pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0430061
UMLS CUI [2]
C0430057
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
Beschrijving

Concomitant Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1707479
patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient's last prior therapy before initiation of treatment on clinical trial
Beschrijving

lenalidomide therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1144149
have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment
Beschrijving

concurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
have significant, uncontrolled active infection
Beschrijving

active infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or nursing patients will be excluded from the study
Beschrijving

pregnant or nursing patients

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
known human immunodeficiency virus (hiv) infection
Beschrijving

hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
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Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
aml
Item
patients eligible include those with diagnosis of aml other than acute promyelocytic leukemia by world health organization (who) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy
boolean
C0023467 (UMLS CUI [1])
eastern cooperative oncology group (ecog)
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
serum creatinine
Item
serum creatinine =< 1.5 mg/dl; if serum creatinine > 1.5 mg/dl, then the estimated glomerular filtrate rate (gfr) must be > 60ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation
boolean
C0201976 (UMLS CUI [1])
serum bilirubin
Item
serum bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is considered to be secondary to gilbert's syndrome, hemolysis, or hepatic infiltration by aml
boolean
C1278039 (UMLS CUI [1])
aspartate transaminase
Item
aspartate transaminase (ast)/alanine transaminase (alt) =< 2.5 x uln
boolean
C0004002 (UMLS CUI [1])
alkaline phosphatase
Item
alkaline phosphatase =< 2.5 x uln
boolean
C0201850 (UMLS CUI [1])
Revlimid
Item
all study participants must be registered into the mandatory revlimid assistance (revassist) program, and be willing and able to comply with the requirements of revassist
boolean
C1135145 (UMLS CUI [1])
negative serum or urine pregnancy test
Item
females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revassist) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide; fcbp must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy
boolean
C0430061 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Concomitant Therapy
Item
patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
boolean
C1707479 (UMLS CUI [1])
lenalidomide therapy
Item
patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient's last prior therapy before initiation of treatment on clinical trial
boolean
C1144149 (UMLS CUI [1])
concurrent disease
Item
have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment
boolean
C0009488 (UMLS CUI [1])
active infection
Item
have significant, uncontrolled active infection
boolean
C0009450 (UMLS CUI [1])
pregnant or nursing patients
Item
pregnant or nursing patients will be excluded from the study
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hiv
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019682 (UMLS CUI [1])
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