ID

12259

Description

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) Description: Registration and Randomization Form

Keywords

Versions (5)
  1. 10/29/15 10/29/15 -
  2. 11/23/15 11/23/15 -
  3. 12/18/15 12/18/15 -
  4. 2/11/16 2/11/16 -
  5. 9/20/21 9/20/21 -
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October 29, 2015

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License

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

English

Registration and Randomization Form

1 forms  
Patient data
Description

Patient data

Alias
UMLS CUI-1
C2707520
Caller
Description

Caller

Data type

text

Alias
UMLS CUI [1]
C0557514
Responsible physician
Description

Responsible physician

Data type

text

Alias
UMLS CUI [1,1]
C1273518
UMLS CUI [1,2]
C0031831
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

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

Date of written Informed Consent

Data type

date

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

Date of diagnosis of AML or MDS

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0023467
UMLS CUI [2,1]
C2316983
UMLS CUI [2,2]
C0026986
Patient consent
Description

Patient consent

Approach for future research
Description

Approach for future research

Data type

boolean

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

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

Data type

boolean

Taking extra bone marrow, blood and saliva for additional research
Description

Taking extra bone marrow, blood and saliva for additional research

Data type

boolean

Eligibility
Description

Eligibility

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

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

Data type

text

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

IPSS-R risk score

Data type

integer

Alias
UMLS CUI [1]
C2827405
WHO performance status
Description

WHO performance status

Data type

integer

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

Sampled BM/PB samples for analysis and MRD evaluation

Data type

text

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

Blood sampling

Data type

date

Alias
UMLS CUI [1]
C0005834
Serum creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
GFR
Description

GFR

Data type

float

Measurement units
  • mL/min/1.73 m2
Alias
UMLS CUI [1]
C1316377
mL/min/1.73 m2
Bilirubin
Description

Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
Bilirubin ULN
Description

Bilirubin ULN

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0005437
UMLS CUI [1,2]
C1519815
mg/dL
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Description

AST ULN

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
ALT (SGPT)
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT (SGPT) ULN
Description

ALT ULN

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0376147
UMLS CUI [1,2]
C1519815
U/L
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0151420
U/L
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Description

Ability and willingness to adhere to lenalidomide pregnancy prevention program

Data type

boolean

Alias
UMLS CUI [1]
C0086286
Previous therapy with lenalidomide
Description

Previous therapy with lenalidomide

Data type

boolean

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

Acute promyelocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
Myeloproliferative neoplasia
Description

Myeloproliferative neoplasia

Data type

boolean

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

Previous treatment for AML or high risk MDS, except hydroxyurea

Data type

boolean

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)
Description

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)

Data type

boolean

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

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

Data type

boolean

Cardiac dysfunction (see protocol section 8.1.2)
Description

Cardiac dysfunction (see protocol section 8.1.2)

Data type

boolean

Alias
UMLS CUI [1]
C3277906
Hypersensitivity to the active substance or to any of the excipients of the drug product
Description

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

Data type

boolean

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

Pregnant or lactating females

Data type

boolean

Alias
UMLS CUI [1,1]
C2828358
UMLS CUI [1,2]
C0549206
Unwilling or not capable to use effective means of birth control
Description

Unwilling or not capable to use effective means of birth control

Data type

boolean

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

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

Data type

boolean

Data from HOVON data center
Description

Data from HOVON data center

Date of Randomization
Description

Date of Randomization

Data type

date

Patient study number
Description

Patient study number

Data type

integer

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

Lenalidomide treatment arm allocated

Data type

text

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Similar models

Registration and Randomization Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient data
C2707520 (UMLS CUI-1)
Caller
Item
Caller
text
C0557514 (UMLS CUI [1])
Responsible physician
Item
Responsible physician
text
C1273518 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
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)
CL Item
Female (2)
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])
C0026986 (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
boolean
Taking extra bone marrow, blood and saliva for additional research
Item
boolean
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)
CL Item
RAEB (2)
CL Item
Leukemia with abiguous lineage (3)
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
text
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
date
C0005834 (UMLS CUI [1])
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
GFR
Item
GFR
float
C1316377 (UMLS CUI [1])
Bilirubin
Item
float
C0005437 (UMLS CUI [1])
Bilirubin ULN
Item
float
C0005437 (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
C0242192 (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
C0376147 (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
C0151420 (UMLS CUI [1])
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Item
Ability and willingness to adhere to lenalidomide pregnancy prevention program
boolean
C0086286 (UMLS CUI [1])
Previous therapy with lenalidomide
Item
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
boolean
C0027022 (UMLS CUI [1])
Previous treatment for AML or high risk MDS, except hydroxyurea
Item
boolean
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
boolean
Cardiac dysfunction (see protocol section 8.1.2)
Item
boolean
C3277906 (UMLS CUI [1])
Hypersensitivity to the active substance or to any of the excipients of the drug product
Item
boolean
C0020517 (UMLS CUI [1])
Pregnant or lactating females
Item
boolean
C2828358 (UMLS CUI [1,1])
C0549206 (UMLS CUI [1,2])
Unwilling or not capable to use effective means of birth control
Item
boolean
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
boolean
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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