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
Mots-clés
Versions (5)
- 29/10/2015 29/10/2015 -
- 23/11/2015 23/11/2015 -
- 18/12/2015 18/12/2015 -
- 11/02/2016 11/02/2016 -
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
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
Type de données
boolean
Description
Keeping body material up to 15 years after trial for additional future research
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1292533
- UMLS CUI [1,2]
- C0021430
Description
Taking extra bone marrow, blood and saliva for additional research
Type de données
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)
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
IPSS-R risk score
Type de données
integer
Alias
- UMLS CUI [1]
- C2827405
Description
WHO performance status
Type de données
integer
Alias
- UMLS CUI [1]
- C1298650
Description
Sampled BM/PB samples for analysis and MRD evaluation
Type de données
integer
Alias
- UMLS CUI [1]
- C0005953
- UMLS CUI [2]
- C0032105
- UMLS CUI [3]
- C2238270
Description
Blood sampling
Type de données
date
Alias
- UMLS CUI [1]
- C0005834
Description
Creatinine, Serum
Type de données
float
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Description
GFR
Type de données
float
Unités de mesure
- mL/min
Alias
- UMLS CUI [1]
- C0017654
Description
Bilirubin
Type de données
float
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0005437
Description
Bilirubin ULN
Type de données
float
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Description
AST
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST ULN
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Description
ALT
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
ALT ULN
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Description
Alkaline Phosphatase
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Alkaline Phosphatase ULN
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1519815
Description
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009862
Description
Previous therapy with lenalidomide
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2114510
- UMLS CUI [1,2]
- C1144149
Description
Acute promyelocytic leukemia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0023487
Description
Myeloproliferative neoplasia
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027022
Description
Previous treatment for AML or high risk MDS, except hydroxyurea
Type de données
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)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Cardiac dysfunction (see protocol section 8.1.2)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018801
Description
Hypersensitivity to the active substance or to any of the excipients of the drug product
Type de données
boolean
Alias
- UMLS CUI [1]
- C0020517
Description
Pregnant or lactating females
Type de données
boolean
Alias
- UMLS CUI [1]
- C2828358
- UMLS CUI [2]
- C0032961
Description
Unwilling or not capable to use effective means of birth control
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Data from HOVON data center
Similar models
Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)
C0023467 (UMLS CUI [1,2])
C2316983 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0032105 (UMLS CUI [2])
C2238270 (UMLS CUI [3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])