ID
12259
Beschreibung
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
Stichworte
Versionen (5)
- 29.10.15 29.10.15 -
- 23.11.15 23.11.15 -
- 18.12.15 18.12.15 -
- 11.02.16 11.02.16 -
- 20.09.21 20.09.21 -
Hochgeladen am
29. Oktober 2015
DOI
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Lizenz
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
- StudyEvent: ODM
Beschreibung
Patient consent
Beschreibung
Approach for future research
Datentyp
boolean
Beschreibung
Keeping body material up to 15 years after trial for additional future research
Datentyp
boolean
Beschreibung
Taking extra bone marrow, blood and saliva for additional research
Datentyp
boolean
Beschreibung
Eligibility
Alias
- UMLS CUI-1
- C0013893
Beschreibung
AML or MDS diagnosis (see protocol appendix A1-3)
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
IPSS-R risk score
Datentyp
integer
Alias
- UMLS CUI [1]
- C2827405
Beschreibung
WHO performance status
Datentyp
integer
Alias
- UMLS CUI [1]
- C1298650
Beschreibung
Sampled BM/PB samples for analysis and MRD evaluation
Datentyp
text
Alias
- UMLS CUI [1]
- C0005953
- UMLS CUI [2]
- C0032105
- UMLS CUI [3]
- C2238270
Beschreibung
Blood sampling
Datentyp
date
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Creatinine, Serum
Datentyp
float
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
GFR
Datentyp
float
Maßeinheiten
- mL/min/1.73 m2
Alias
- UMLS CUI [1]
- C1316377
Beschreibung
Bilirubin
Datentyp
float
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0005437
Beschreibung
Bilirubin ULN
Datentyp
float
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1,1]
- C0005437
- UMLS CUI [1,2]
- C1519815
Beschreibung
AST
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
AST ULN
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1,1]
- C0242192
- UMLS CUI [1,2]
- C1519815
Beschreibung
ALT
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
ALT ULN
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1,1]
- C0376147
- UMLS CUI [1,2]
- C1519815
Beschreibung
Alkaline Phosphatase
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
Alkaline Phosphatase ULN
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0151420
Beschreibung
Ability and willingness to adhere to lenalidomide pregnancy prevention program
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0086286
Beschreibung
Previous therapy with lenalidomide
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2114510
- UMLS CUI [1,2]
- C1144149
Beschreibung
Acute promyelocytic leukemia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023487
Beschreibung
Myeloproliferative neoplasia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027022
Beschreibung
Previous treatment for AML or high risk MDS, except hydroxyurea
Datentyp
boolean
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
Datentyp
boolean
Beschreibung
Cardiac dysfunction (see protocol section 8.1.2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3277906
Beschreibung
Hypersensitivity to the active substance or to any of the excipients of the drug product
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0020517
Beschreibung
Pregnant or lactating females
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2828358
- UMLS CUI [1,2]
- C0549206
Beschreibung
Unwilling or not capable to use effective means of birth control
Datentyp
boolean
Beschreibung
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Datentyp
boolean
Beschreibung
Data from HOVON data center
Ähnliche Modelle
Registration and Randomization Form
- StudyEvent: ODM
C0031831 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
C2316983 (UMLS CUI [2,1])
C0026986 (UMLS CUI [2,2])
C0032105 (UMLS CUI [2])
C2238270 (UMLS CUI [3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1144149 (UMLS CUI [1,2])
C0549206 (UMLS CUI [1,2])