ID

30244

Beschreibung

Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00875745

Link

https://clinicaltrials.gov/show/NCT00875745

Stichworte

Versionen (1)
  1. 24.05.18 24.05.18 -
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See clinicaltrials.gov

Hochgeladen am

24. Mai 2018

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT00875745

Englisch

Eligibility Leukemia, Myeloid, Acute NCT00875745

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a diagnosis of aml (> 20% myeloid blasts in the peripheral blood or bone marrow) or mds with > 10% myeloid blasts in the bone marrow. patients with acute promyelocytic leukemia (apl) must be refractory to all-trans retinoic acid (atra) and arsenic trioxide.
Beschreibung

Leukemia, Myelocytic, Acute | Blasts Myeloid Percentage Peripheral blood | Blasts Bone marrow Percentage | MYELODYSPLASTIC SYNDROME | Acute Promyelocytic Leukemia Unresponsive to Treatment | Tretinoin | arsenic trioxide

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0439677
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0229664
UMLS CUI [3,1]
C1982687
UMLS CUI [3,2]
C0439165
UMLS CUI [4]
C3463824
UMLS CUI [5,1]
C0023487
UMLS CUI [5,2]
C0205269
UMLS CUI [6]
C0040845
UMLS CUI [7]
C0052416
the patients must have one of the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
Beschreibung

Age | Recurrent disease | Refractory Disease | Prior Therapy Quantity | Patient Inappropriate Cytotoxic therapy | Patient Inappropriate Conventional Treatment | Poor performance status | Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C0677881
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C2945704
UMLS CUI [7]
C1831741
UMLS CUI [8]
C0009488
age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
Beschreibung

Age | Prior Therapy Absent | Exception Hematopoietic Cell Growth Factors | Exception Hydroxyurea | Patient Inappropriate Cytotoxic therapy | Patient Inappropriate Conventional Treatment | Poor performance status | Comorbidity | Preference Personal

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0079490
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020402
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C0677881
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C2945704
UMLS CUI [7]
C1831741
UMLS CUI [8]
C0009488
UMLS CUI [9,1]
C0558295
UMLS CUI [9,2]
C1519021
age of 70 years or older with relapsed or refractory disease
Beschreibung

Age | Recurrent disease | Refractory Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
the patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
Beschreibung

Prior Therapy Discontinued Acute leukemia | Effects of Therapeutic procedure Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0085669
UMLS CUI [2,1]
C1704420
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1115804
patients must have an ecog (zubrod) performance status of 0-2
Beschreibung

ECOG performance status | Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C3714786
patients must be able to take and tolerate oral medications
Beschreibung

Able to take medication Oral | Patient Tolerable Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C4053931
UMLS CUI [2,3]
C0175795
patients must have adequate organ function as specified in the protocol.
Beschreibung

Organ function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
patients not on anti-coagulation must have an inr < 1.5 and a ptt within normal limits.
Beschreibung

Anticoagulation Therapy Absent | International Normalized Ratio | PTT Normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0525032
UMLS CUI [3,1]
C0030605
UMLS CUI [3,2]
C0205307
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women or nursing mothers are not eligible for this trial.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
Beschreibung

Biological treatment | Cytotoxic Chemotherapy | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0677881
UMLS CUI [3]
C1522449
patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. see protocol for listing.
Beschreibung

Medical condition Pre-existing Serious Quantity | Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
patients with known central nervous system (cns) leukemia by spinal fluid cytology, flow cytometry or imaging
Beschreibung

Central nervous system leukaemia Spinal Fluid Cytology | Central nervous system leukaemia Flow Cytometry | Central nervous system leukaemia Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332884
UMLS CUI [1,2]
C0007806
UMLS CUI [1,3]
C1305671
UMLS CUI [2,1]
C1332884
UMLS CUI [2,2]
C0016263
UMLS CUI [3,1]
C1332884
UMLS CUI [3,2]
C0011923
patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
Beschreibung

Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation | Side effects Interfere with Interpretation Toxicity

Datentyp

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C1705576
UMLS CUI [3,1]
C0001688
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0600688
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Ähnliche Modelle

Eligibility Leukemia, Myeloid, Acute NCT00875745

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | Blasts Myeloid Percentage Peripheral blood | Blasts Bone marrow Percentage | MYELODYSPLASTIC SYNDROME | Acute Promyelocytic Leukemia Unresponsive to Treatment | Tretinoin | arsenic trioxide
Item
patients must have a diagnosis of aml (> 20% myeloid blasts in the peripheral blood or bone marrow) or mds with > 10% myeloid blasts in the bone marrow. patients with acute promyelocytic leukemia (apl) must be refractory to all-trans retinoic acid (atra) and arsenic trioxide.
boolean
C0023467 (UMLS CUI [1])
C0368761 (UMLS CUI [2,1])
C0439677 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0229664 (UMLS CUI [2,4])
C1982687 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C3463824 (UMLS CUI [4])
C0023487 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C0040845 (UMLS CUI [6])
C0052416 (UMLS CUI [7])
Criteria Fulfill
Item
the patients must have one of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age | Recurrent disease | Refractory Disease | Prior Therapy Quantity | Patient Inappropriate Cytotoxic therapy | Patient Inappropriate Conventional Treatment | Poor performance status | Comorbidity
Item
age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
boolean
C0001779 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0677881 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C2945704 (UMLS CUI [6,3])
C1831741 (UMLS CUI [7])
C0009488 (UMLS CUI [8])
Age | Prior Therapy Absent | Exception Hematopoietic Cell Growth Factors | Exception Hydroxyurea | Patient Inappropriate Cytotoxic therapy | Patient Inappropriate Conventional Treatment | Poor performance status | Comorbidity | Preference Personal
Item
age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
boolean
C0001779 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0079490 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020402 (UMLS CUI [4,2])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0677881 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C2945704 (UMLS CUI [6,3])
C1831741 (UMLS CUI [7])
C0009488 (UMLS CUI [8])
C0558295 (UMLS CUI [9,1])
C1519021 (UMLS CUI [9,2])
Age | Recurrent disease | Refractory Disease
Item
age of 70 years or older with relapsed or refractory disease
boolean
C0001779 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
Prior Therapy Discontinued Acute leukemia | Effects of Therapeutic procedure Patient recovered
Item
the patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
boolean
C1514463 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0085669 (UMLS CUI [1,3])
C1704420 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1115804 (UMLS CUI [2,3])
ECOG performance status | Zubrod Performance Status
Item
patients must have an ecog (zubrod) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
Able to take medication Oral | Patient Tolerable Oral medication
Item
patients must be able to take and tolerate oral medications
boolean
C4075001 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C4053931 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Organ function
Item
patients must have adequate organ function as specified in the protocol.
boolean
C0678852 (UMLS CUI [1])
Anticoagulation Therapy Absent | International Normalized Ratio | PTT Normal
Item
patients not on anti-coagulation must have an inr < 1.5 and a ptt within normal limits.
boolean
C0003281 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2])
C0030605 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers are not eligible for this trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Biological treatment | Cytotoxic Chemotherapy | Therapeutic radiology procedure
Item
patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
boolean
C1531518 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Medical condition Pre-existing Serious Quantity | Study Subject Participation Status Excluded
Item
patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. see protocol for listing.
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Central nervous system leukaemia Spinal Fluid Cytology | Central nervous system leukaemia Flow Cytometry | Central nervous system leukaemia Imaging
Item
patients with known central nervous system (cns) leukemia by spinal fluid cytology, flow cytometry or imaging
boolean
C1332884 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
C1305671 (UMLS CUI [1,3])
C1332884 (UMLS CUI [2,1])
C0016263 (UMLS CUI [2,2])
C1332884 (UMLS CUI [3,1])
C0011923 (UMLS CUI [3,2])
Transplantation of autologous hematopoietic stem cell | Allogeneic Hematopoietic Stem Cell Transplantation | Side effects Interfere with Interpretation Toxicity
Item
patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
boolean
C1831743 (UMLS CUI [1])
C1705576 (UMLS CUI [2])
C0001688 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0600688 (UMLS CUI [3,4])
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