ID

43608

Beskrivning

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) With friendly permission of HOVON-Group - Prof. G. Ossenkoppele

Nyckelord

Versioner (5)
  1. 2015-10-29 2015-10-29 -
  2. 2015-11-23 2015-11-23 -
  3. 2015-12-18 2015-12-18 -
  4. 2016-02-11 2016-02-11 -
  5. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

Engelsk

Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

1 Formulär  
Patient data
Beskrivning

Patient data

Alias
UMLS CUI-1
C2707520
Caller
Beskrivning

Caller

Datatyp

text

Alias
UMLS CUI [1]
C0557514
Responsible physician
Beskrivning

Responsible physician

Datatyp

text

Alias
UMLS CUI [1]
C0031831
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Sex

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Date of written Informed Consent
Beskrivning

Date of written Informed Consent

Datatyp

date

Alias
UMLS CUI [1]
C2985782
Date of diagnosis of AML or MDS
Beskrivning

Date of diagnosis of AML or MDS

Datatyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0023467
UMLS CUI [2,1]
C2316983
UMLS CUI [2,2]
C3463824
Patient consent
Beskrivning

Patient consent

Approach for future research
Beskrivning

Approach for future research

Datatyp

boolean

Keeping body material up to 15 years after trial for additional future research
Beskrivning

Keeping body material up to 15 years after trial for additional future research

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0021430
Taking extra bone marrow, blood and saliva for additional research
Beskrivning

Taking extra bone marrow, blood and saliva for additional research

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0021430
Eligibility
Beskrivning

Eligibility

Alias
UMLS CUI-1
C0013893
AML or MDS diagnosis (see protocol appendix A1-3)
Beskrivning

AML or MDS diagnosis (see protocol appendix A1-3)

Datatyp

text

Alias
UMLS CUI [1]
C0011900
IPSS-R risk score
Beskrivning

IPSS-R risk score

Datatyp

integer

Alias
UMLS CUI [1]
C2827405
WHO performance status
Beskrivning

WHO performance status

Datatyp

integer

Alias
UMLS CUI [1]
C1298650
Sampled BM/PB samples for analysis and MRD evaluation
Beskrivning

Sampled BM/PB samples for analysis and MRD evaluation

Datatyp

integer

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0032105
UMLS CUI [3]
C2238270
Blood sampling
Beskrivning

Blood sampling

Datatyp

date

Alias
UMLS CUI [1]
C0005834
Serum creatinine
Beskrivning

Creatinine, Serum

Datatyp

float

Måttenheter
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
GFR
Beskrivning

GFR

Datatyp

float

Måttenheter
  • mL/min
Alias
UMLS CUI [1]
C0017654
mL/min
Bilirubin
Beskrivning

Bilirubin

Datatyp

float

Måttenheter
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
Bilirubin ULN
Beskrivning

Bilirubin ULN

Datatyp

float

Måttenheter
  • mg/dL
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
AST (SGOT)
Beskrivning

AST

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Beskrivning

AST ULN

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
U/L
ALT (SGPT)
Beskrivning

ALT

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT (SGPT) ULN
Beskrivning

ALT ULN

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
U/L
Alkaline Phosphatase
Beskrivning

Alkaline Phosphatase

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Beskrivning

Alkaline Phosphatase ULN

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519815
U/L
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Beskrivning

Ability and willingness to adhere to lenalidomide pregnancy prevention program

Datatyp

boolean

Alias
UMLS CUI [1]
C0009862
Previous therapy with lenalidomide
Beskrivning

Previous therapy with lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2114510
UMLS CUI [1,2]
C1144149
Acute promyelocytic leukemia
Beskrivning

Acute promyelocytic leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
Myeloproliferative neoplasia
Beskrivning

Myeloproliferative neoplasia

Datatyp

boolean

Alias
UMLS CUI [1]
C0027022
Previous treatment for AML or high risk MDS, except hydroxyurea
Beskrivning

Previous treatment for AML or high risk MDS, except hydroxyurea

Datatyp

boolean

Alias
UMLS CUI [1]
C2114510
Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)
Beskrivning

Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Beskrivning

Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
Cardiac dysfunction (see protocol section 8.1.2)
Beskrivning

Cardiac dysfunction (see protocol section 8.1.2)

Datatyp

boolean

Alias
UMLS CUI [1]
C0018801
Hypersensitivity to the active substance or to any of the excipients of the drug product
Beskrivning

Hypersensitivity to the active substance or to any of the excipients of the drug product

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
Pregnant or lactating females
Beskrivning

Pregnant or lactating females

Datatyp

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0032961
Unwilling or not capable to use effective means of birth control
Beskrivning

Unwilling or not capable to use effective means of birth control

Datatyp

boolean

Alias
UMLS CUI [1]
C0009862
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beskrivning

Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Data from HOVON data center
Beskrivning

Data from HOVON data center

Date of Randomization
Beskrivning

Date of Randomization

Datatyp

date

Patient study number
Beskrivning

Patient study number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Lenalidomide treatment arm allocated
Beskrivning

Lenalidomide treatment arm allocated

Datatyp

text

Tillbaka till toppen

Similar models

Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Patient data
C2707520 (UMLS CUI-1)
Caller
Item
Caller
text
C0557514 (UMLS CUI [1])
Responsible physician
Item
Responsible physician
text
C0031831 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
C0086582 (UMLS CUI-1)
CL Item
Female (2)
C0086287 (UMLS CUI-1)
Date of written Informed Consent
Item
Date of written Informed Consent
date
C2985782 (UMLS CUI [1])
Date of diagnosis of AML or MDS
Item
Date of diagnosis of AML or MDS
date
C2316983 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C2316983 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
Item Group
Patient consent
Approach for future research
Item
Approach for future research
boolean
Keeping body material up to 15 years after trial for additional future research
Item
Keeping body material up to 15 years after trial for additional future research
boolean
C1292533 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Taking extra bone marrow, blood and saliva for additional research
Item
Taking extra bone marrow, blood and saliva for additional research
boolean
C1292533 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item Group
C0013893 (UMLS CUI-1)
Item
AML or MDS diagnosis (see protocol appendix A1-3)
text
C0011900 (UMLS CUI [1])
AML or MDS diagnosis (see protocol appendix A1-3)
Code List
AML or MDS diagnosis (see protocol appendix A1-3)
CL Item
AML (1)
C0023467 (UMLS CUI-1)
CL Item
RAEB (2)
C0002894 (UMLS CUI-1)
CL Item
Leukemia with ambiguous lineage (3)
C1301357 (UMLS CUI-1)
IPSS-R risk score
Item
integer
C2827405 (UMLS CUI [1])
Item
WHO performance status
integer
C1298650 (UMLS CUI [1])
WHO performance status
Code List
WHO performance status
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Sampled BM/PB samples for analysis and MRD evaluation
integer
C0005953 (UMLS CUI [1])
C0032105 (UMLS CUI [2])
C2238270 (UMLS CUI [3])
Sampled BM/PB samples for analysis and MRD evaluation
Code List
Sampled BM/PB samples for analysis and MRD evaluation
CL Item
no (0)
CL Item
yes (1)
CL Item
dry tap (2)
Blood sampling
Item
Blood sampling
date
C0005834 (UMLS CUI [1])
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
GFR
Item
GFR
float
C0017654 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C0005437 (UMLS CUI [1])
Bilirubin ULN
Item
Bilirubin ULN
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C0201850 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Item
Ability and willingness to adhere to lenalidomide pregnancy prevention program
boolean
C0009862 (UMLS CUI [1])
Previous therapy with lenalidomide
Item
Previous therapy with lenalidomide
boolean
C2114510 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
Acute promyelocytic leukemia
Item
Acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
Myeloproliferative neoplasia
Item
Myeloproliferative neoplasia
boolean
C0027022 (UMLS CUI [1])
Previous treatment for AML or high risk MDS, except hydroxyurea
Item
Previous treatment for AML or high risk MDS, except hydroxyurea
boolean
C2114510 (UMLS CUI [1])
Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)
Item
Concurrent history of active malignancy in two past years prior to diagnosis (except for basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix)
boolean
C0006826 (UMLS CUI [1])
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Item
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
boolean
C0009488 (UMLS CUI [1])
Cardiac dysfunction (see protocol section 8.1.2)
Item
Cardiac dysfunction (see protocol section 8.1.2)
boolean
C0018801 (UMLS CUI [1])
Hypersensitivity to the active substance or to any of the excipients of the drug product
Item
Hypersensitivity to the active substance or to any of the excipients of the drug product
boolean
C0020517 (UMLS CUI [1])
Pregnant or lactating females
Item
Pregnant or lactating females
boolean
C2828358 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Unwilling or not capable to use effective means of birth control
Item
Unwilling or not capable to use effective means of birth control
boolean
C0009862 (UMLS CUI [1])
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0525058 (UMLS CUI [1])
Date of Randomization
Item
Date of Randomization
date
Patient study number
Item
integer
C1830427 (UMLS CUI [1])
Lenalidomide treatment arm allocated
Code List
Lenalidomide treatment arm allocated
CL Item
Arm A: induction chemotherapy without Lenalidomide (1)
CL Item
Arm B: induction chemotherapy with Lenalidomide 20mg (2)
CL Item
Arm B: induction chemotherapy with Lenalidomide 15mg (5)
CL Item
Arm B: induction chemotherapy with Lenalidomide 10mg (6)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial