ID
43608
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) With friendly permission of HOVON-Group - Prof. G. Ossenkoppele
Keywords
Versions (5)
- 10/29/15 10/29/15 -
- 11/23/15 11/23/15 -
- 12/18/15 12/18/15 -
- 2/11/16 2/11/16 -
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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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)
Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)
Description
Patient consent
Description
Approach for future research
Data type
boolean
Description
Keeping body material up to 15 years after trial for additional future research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1292533
- UMLS CUI [1,2]
- C0021430
Description
Taking extra bone marrow, blood and saliva for additional research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1292533
- UMLS CUI [1,2]
- C0021430
Description
Eligibility
Alias
- UMLS CUI-1
- C0013893
Description
AML or MDS diagnosis (see protocol appendix A1-3)
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
IPSS-R risk score
Data type
integer
Alias
- UMLS CUI [1]
- C2827405
Description
WHO performance status
Data type
integer
Alias
- UMLS CUI [1]
- C1298650
Description
Sampled BM/PB samples for analysis and MRD evaluation
Data type
integer
Alias
- UMLS CUI [1]
- C0005953
- UMLS CUI [2]
- C0032105
- UMLS CUI [3]
- C2238270
Description
Blood sampling
Data type
date
Alias
- UMLS CUI [1]
- C0005834
Description
Creatinine, Serum
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
GFR
Data type
float
Measurement units
- mL/min
Alias
- UMLS CUI [1]
- C0017654
Description
Bilirubin
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1]
- C0005437
Description
Bilirubin ULN
Data type
float
Measurement units
- mg/dL
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
ALT ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Description
Alkaline Phosphatase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Alkaline Phosphatase ULN
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1519815
Description
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Data type
boolean
Alias
- UMLS CUI [1]
- C0009862
Description
Previous therapy with lenalidomide
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2114510
- UMLS CUI [1,2]
- C1144149
Description
Acute promyelocytic leukemia
Data type
boolean
Alias
- UMLS CUI [1]
- C0023487
Description
Myeloproliferative neoplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C0027022
Description
Previous treatment for AML or high risk MDS, except hydroxyurea
Data type
boolean
Alias
- UMLS CUI [1]
- C2114510
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
Description
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Cardiac dysfunction (see protocol section 8.1.2)
Data type
boolean
Alias
- UMLS CUI [1]
- C0018801
Description
Hypersensitivity to the active substance or to any of the excipients of the drug product
Data type
boolean
Alias
- UMLS CUI [1]
- C0020517
Description
Pregnant or lactating females
Data type
boolean
Alias
- UMLS CUI [1]
- C2828358
- UMLS CUI [2]
- C0032961
Description
Unwilling or not capable to use effective means of birth control
Data type
boolean
Alias
- UMLS CUI [1]
- C0009862
Description
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Data type
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Data from HOVON data center
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