ID

44582

Beschrijving

Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations see http://clinicaltrials.gov/show/NCT00989261

Link

http://clinicaltrials.gov/show/NCT00989261

Trefwoorden

AML

D016430

Eligibility Determination

Leukämie

Geüploaded op

27 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility NCT00989261 Acute Myeloid Leukemia

model
Details

Eligibility AML NCT00989261

1 Formulieren

StudyEvent: Eligibility
1. Eligibility AML NCT00989261

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

Einschlusskriterien

CL425202 (UMLS CUI 2011AA)

age 18 Years to 85 Years

Item

Alter 18 bis 85 Jahre

boolean

397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)

Age 18+ and in second relapse or refractory

Item

Males and females age ≥18 years in second relapse or refractory.

boolean

248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
397669002 (SNOMED CT 2011_0131)
81170007 (SNOMED CT 2011_0131)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
C0205436 (UMLS CUI-2)
C0277556 (UMLS CUI-3)
C0205269 (UMLS CUI-4)

Age 60+ in first relapse or refractory.

Item

Males and females age ≥60 years in first relapse or refractory.

boolean

248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
397669002 (SNOMED CT 2011_0131)
255216001 (SNOMED CT 2011_0131)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
C0205435 (UMLS CUI-2)
C0277556 (UMLS CUI-3)
C0205269 (UMLS CUI-4)

Baseline bone marrow sample

Item

Must have baseline bone marrow sample taken.

boolean

119359002 (SNOMED CT 2011_0131)
C1442488 (UMLS CUI-1)
C0438737 (UMLS CUI-2)

Primary AML or AML secondary to MDS

Item

Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.

boolean

116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
397934002 (SNOMED CT 2011_0131)
91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
273931002 (SNOMED CT 2011_0131)
29458008 (SNOMED CT 2011_0131)
REV (HL7 V3 2006_05)
C0332437 (UMLS CUI-1)
C1301725 (UMLS CUI-2)
CL414904 (UMLS CUI-3)
C0023467 (UMLS CUI-4)
C0280449 (UMLS CUI-5)
C3463824 (UMLS CUI-6)
C0750484 (UMLS CUI-7)
C1521733 (UMLS CUI-8)

Able to swallow study drug

Item

Able to swallow the liquid study drug.

boolean

288936000 (SNOMED CT 2011_0131)
33463005 (SNOMED CT 2011_0131)
902003 (SNOMED CT 2011_0131)
C2712086 (UMLS CUI-1)
C0304229 (UMLS CUI-2)

ECOG status 0-2

Item

ECOG performance status of 0 to 2

boolean

C1520224 (UMLS CUI-1)

Prior therapy

Item

In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.

boolean

385673002 (SNOMED CT 2011_0131)
416118004 (SNOMED CT 2011_0131)
373526007 (SNOMED CT 2011_0131)
NP (HL7 V3 2006_05)
312059006 (SNOMED CT 2011_0131)
56602009 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
72607000 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI-1)

Persistent non-hematological toxicities <= Grade 1.

Item

Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤ Grade 1.

boolean

57407000 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI-1)
C2826262 (UMLS CUI-2)

Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220

Item

Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.

boolean

75554001 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
C0521104 (UMLS CUI-1)
C1514463 (UMLS CUI-2)
C1333568 (UMLS CUI-3)
C0243077 (UMLS CUI-4)
C1554961 (UMLS CUI-5)
CL374311 (UMLS CUI-6)

Serum creatinine and GFR

Item

Serum creatinine ≤1.5 × ULN and glomerular filtration rate (GFR) > 30 mL/min

boolean

113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
C0201976 (UMLS CUI-1)
C0017654 (UMLS CUI-2)

Serum potassium, magnesium, and calcium normal

Item

Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.

boolean

166688007 (SNOMED CT 2011_0131)
10040338 (MedDRA 14.1)
166701009 (SNOMED CT 2011_0131)
C0580477 (UMLS CUI-1)
C0858145 (UMLS CUI-2)
C0580486 (UMLS CUI-3)

Serum bilirubin

Item

Total serum bilirubin ≤1.5 × ULN

boolean

166610007 (SNOMED CT 2011_0131)
10040157 (MedDRA 14.1)
C1278039 (UMLS CUI-1)

AST and ALT

Item

Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN

boolean

26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI-1)
C0001899 (UMLS CUI-2)

Negative pregnancy test

Item

Females of childbearing potential must have a negative pregnancy test (urine β-hCG).

boolean

248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
410525008 (SNOMED CT 2011_0131)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
40940006 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI-1)

Contraception

Item

Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.

boolean

248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
86571001 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0700589 (UMLS CUI-1)

Written informed consent

Item

Procurement of patient informed consent, investigational study

boolean

55149002 (SNOMED CT 2011_0131)
C0021430 (UMLS CUI-1)

Exclusion Criteria

Item Group

Ausschlusskriterien

CL425201 (UMLS CUI 2011AA)

Age

Item

Alter >85 Jahre

boolean

397669002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)

Acute promyelocytic leukemia

Item

Diagnosis of acute promyelocytic leukemia

boolean

439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
110004001 (SNOMED CT 2011_0131)
10001019 (MedDRA 14.1)
C92.4 (ICD-10-CM Version 2010)
C0023487 (UMLS CUI-1)

CML in blast crisis

Item

Diagnosis of chronic myelogenous leukemia (CML) in blast crisis

boolean

439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
63364005 (SNOMED CT 2011_0131)
10009700 (MedDRA 14.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
278180008 (SNOMED CT 2011_0131)
10053747 (MedDRA 14.1)
C0023473 (UMLS CUI-1)
C0005699 (UMLS CUI-2)

AML in relapse or refractory

Item

AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment

boolean

91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
58184002 (SNOMED CT 2011_0131)
20646008 (SNOMED CT 2011_0131)
237679004 (SNOMED CT 2011_0131)
150415003 (SNOMED CT 2011_0131)
10067862 (MedDRA 14.1)
C0023467 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
C0205269 (UMLS CUI-3)

AML or antecedent MDS secondary to prior chemotherapy

Item

AML or antecedent MDS secondary to prior chemotherapy

boolean

91861009 (SNOMED CT 2011_0131)
10000880 (MedDRA 14.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
288556008 (SNOMED CT 2011_0131)
128623006 (SNOMED CT 2011_0131)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
2603003 (SNOMED CT 2011_0131)
C0023467 (UMLS CUI-1)
C3463824 (UMLS CUI-2)
C0175668 (UMLS CUI-3)
C1514457 (UMLS CUI-4)

non-hematological toxicity Grade >1 from prior chemotherapy

Item

Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy

boolean

57407000 (SNOMED CT 2011_0131)
C1514457 (UMLS CUI-1)
C0040539 (UMLS CUI-2)
C1513374 (UMLS CUI-3)
C1519275 (UMLS CUI-4)

HSCT, GVHD, toxicity

Item

Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant

boolean

10067862 (MedDRA 14.1)
372823004, 69431002 (SNOMED CT 2011_0131)
234646005 (SNOMED CT 2011_0131)
10018651 (MedDRA 14.1)
D89.813 (ICD-10-CM Version 2010)
279.50 (ICD-9-CM Version 2011)
57407000 (SNOMED CT 2011_0131)
263498003 (SNOMED CT 2011_0131)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C2242529 (UMLS CUI-1)
C0021081 (UMLS CUI-2)
C0018133 (UMLS CUI-3)
C2826262 (UMLS CUI-4)

Central Nervous System Leukemia

Item

ZNS-Leukämie

boolean

10067299 (SNOMED CT 2011_0131)
C1332884 (UMLS CUI-1)

previously received AC220

Item

Patients who have previously received AC220

boolean

9130008 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI-1)
C1514756 (UMLS CUI-2)
CL374311 (UMLS CUI-3)

Disseminated intravascular coagulation

Item

Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)

boolean

67406007 (SNOMED CT 2011_0131)
10013442 (MedDRA 14.1)
D65 (ICD-10-CM Version 2010)
286.6 (ICD-9-CM Version 2011)
E10028 (CTCAE 1105E)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
225886003 (SNOMED CT 2011_0131)
C0012739 (UMLS CUI-1)

Major surgery within 4 weeks prior to enrollment

Item

Major surgery within 4 weeks prior to enrollment in the study

boolean

288556008 (SNOMED CT 2011_0131)
C0679637 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C1516879 (UMLS CUI-3)

Radiotherapy

Item

Radiation therapy within 4 weeks prior to, or concurrent with study

boolean

288556008 (SNOMED CT 2011_0131)
68405009 (SNOMED CT 2011_0131)
110465008 (SNOMED CT 2011_0131)
C0034619 (UMLS CUI-1)

QT interval, CYP3A4 inhibitors

Item

Use of concomitant drugs that prolong QT/QTc interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.

boolean

111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
422741004 (SNOMED CT 2011_0131)
E (HL7 V3 2006_05)
255631004 (SNOMED CT 2011_0131)
373219008 (SNOMED CT 2011_0131)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C2347852 (UMLS CUI-1)
C0151878 (UMLS CUI-2)
C1560305 (UMLS CUI-3)
C1142644 (UMLS CUI-4)
C0243077 (UMLS CUI-5)

Cardiovascular disease

Item

Uncontrolled or significant cardiovascular disease

boolean

19032002 (SNOMED CT 2011_0131)
386134007 (SNOMED CT 2011_0131)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0007222 (UMLS CUI-1)

Pregnant, lactating, or unwilling to use contraception

Item

Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential

boolean

224526002 (SNOMED CT 2011_0131)
10036586 (MedDRA 14.1)
225465005 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0549206 (UMLS CUI-1)
C2828358 (UMLS CUI-2)
C0558080 (UMLS CUI-3)
C0700589 (UMLS CUI-4)

Men who are unwilling to use contraception

Item

Men who are unwilling to use contraception if their partners are of childbearing potential

boolean

339947000 (SNOMED CT 2011_0131)
225465005 (SNOMED CT 2011_0131)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
C0025266 (UMLS CUI-1)
C0558080 (UMLS CUI-2)
C0700589 (UMLS CUI-3)

Active, uncontrolled infection

Item

Active, uncontrolled infection

boolean

C0205177 (UMLS CUI-1)
C0205318 (UMLS CUI-2)
C0009450 (UMLS CUI-3)

Human immunodeficiency virus positivity

Item

HIV-positiv

boolean

C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)

Active hepatitis B or C or other active liver disease

Item

Active hepatitis B or C or other active liver disease

boolean

C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)

History of cancer

Item

History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission

boolean

MTHU034770 (LOINC Version 232)
E (HL7 V3 2006_05)
10008345 (MedDRA 14.1)
10040810 (MedDRA 14.1)
103338009 (SNOMED CT 2011_0131)
C2735088 (UMLS CUI-1)

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Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Eligibility NCT00989261 Acute Myeloid Leukemia

Eligibility AML NCT00989261

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