ID

14567

Description

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

Keywords

Versions (1)
  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

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License

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

English

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

1 forms  
Inclusion Criteria
Description

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
Description

aml

Data type

boolean

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

eastern cooperative oncology group (ecog)

Data type

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
Description

serum creatinine

Data type

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
Description

serum bilirubin

Data type

boolean

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

aspartate transaminase

Data type

boolean

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

alkaline phosphatase

Data type

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
Description

Revlimid

Data type

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
Description

negative serum or urine pregnancy test

Data type

boolean

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

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
Description

Concomitant Therapy

Data type

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
Description

lenalidomide therapy

Data type

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
Description

concurrent disease

Data type

boolean

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

active infection

Data type

boolean

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

pregnant or nursing patients

Data type

boolean

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

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
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Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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