ID

43608

Beschrijving

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

Trefwoorden

Versies (5)
  1. 29-10-15 29-10-15 -
  2. 23-11-15 23-11-15 -
  3. 18-12-15 18-12-15 -
  4. 11-02-16 11-02-16 -
  5. 20-09-21 20-09-21 -
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20 september 2021

DOI

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Creative Commons BY-NC 3.0
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Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

Engels

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

1 Formulieren  
Patient data
Beschrijving

Patient data

Alias
UMLS CUI-1
C2707520
Caller
Beschrijving

Caller

Datatype

text

Alias
UMLS CUI [1]
C0557514
Responsible physician
Beschrijving

Responsible physician

Datatype

text

Alias
UMLS CUI [1]
C0031831
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

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

Date of written Informed Consent

Datatype

date

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

Date of diagnosis of AML or MDS

Datatype

date

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

Patient consent

Approach for future research
Beschrijving

Approach for future research

Datatype

boolean

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

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

Datatype

boolean

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

Taking extra bone marrow, blood and saliva for additional research

Datatype

boolean

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

Eligibility

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

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

Datatype

text

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

IPSS-R risk score

Datatype

integer

Alias
UMLS CUI [1]
C2827405
WHO performance status
Beschrijving

WHO performance status

Datatype

integer

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

Sampled BM/PB samples for analysis and MRD evaluation

Datatype

integer

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

Blood sampling

Datatype

date

Alias
UMLS CUI [1]
C0005834
Serum creatinine
Beschrijving

Creatinine, Serum

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
GFR
Beschrijving

GFR

Datatype

float

Maateenheden
  • mL/min
Alias
UMLS CUI [1]
C0017654
mL/min
Bilirubin
Beschrijving

Bilirubin

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
Bilirubin ULN
Beschrijving

Bilirubin ULN

Datatype

float

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

AST

Datatype

float

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

AST ULN

Datatype

float

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

ALT

Datatype

float

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

ALT ULN

Datatype

float

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

Alkaline Phosphatase

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Beschrijving

Alkaline Phosphatase ULN

Datatype

float

Maateenheden
  • 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
Beschrijving

Ability and willingness to adhere to lenalidomide pregnancy prevention program

Datatype

boolean

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

Previous therapy with lenalidomide

Datatype

boolean

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

Acute promyelocytic leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0023487
Myeloproliferative neoplasia
Beschrijving

Myeloproliferative neoplasia

Datatype

boolean

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

Previous treatment for AML or high risk MDS, except hydroxyurea

Datatype

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)
Beschrijving

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)

Datatype

boolean

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

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

Datatype

boolean

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

Cardiac dysfunction (see protocol section 8.1.2)

Datatype

boolean

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

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

Datatype

boolean

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

Pregnant or lactating females

Datatype

boolean

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

Unwilling or not capable to use effective means of birth control

Datatype

boolean

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

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

Datatype

boolean

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

Data from HOVON data center

Date of Randomization
Beschrijving

Date of Randomization

Datatype

date

Patient study number
Beschrijving

Patient study number

Datatype

integer

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

Lenalidomide treatment arm allocated

Datatype

text

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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