ID

30984

Beschreibung

Study of EB10 in Patients With Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00887926

Link

https://clinicaltrials.gov/show/NCT00887926

Stichworte

Versionen (2)
  1. 09.07.18 09.07.18 -
  2. 09.07.18 09.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Juli 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Myeloid Leukemia NCT00887926

Englisch

Eligibility Myeloid Leukemia NCT00887926

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the patient has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission
Beschreibung

Recurrent adult acute myeloid leukemia Bone Marrow | Recurrent adult acute myeloid leukemia Blood | In complete remission Previous | Complete remission Previous Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278780
UMLS CUI [1,2]
C0005953
UMLS CUI [2,1]
C0278780
UMLS CUI [2,2]
C0005767
UMLS CUI [3,1]
C0677874
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0677874
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C0332197
2. the patient is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia
Beschreibung

Patient Inappropriate Curative treatment Acute Myelocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1273390
UMLS CUI [1,4]
C0023467
3. the patient has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria
Beschreibung

Toxicity Due to Cancer treatment | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
UMLS CUI [2]
C1115804
4. the patient has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of imc-eb10
Beschreibung

Major surgery Absent | Incisional biopsy Absent | Injury Absent | Cancer treatment Absent | Exception Antileukemic Agent | IMC-EB10

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0184922
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3263723
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0920425
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0596112
UMLS CUI [6]
C2830134
5. the patient has a performance status of 0, 1, or 2 at study entry.
Beschreibung

Performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
6. the patient is age 18 years or older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. the patient has a life expectancy of > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
8. the patient has adequate liver and kidney function, as defined in the entry criteria
Beschreibung

Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
9. the patient is using an effective contraception (per the institutional standard), if procreative potential exists
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
10. the patient is able to give written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
11. the patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the patient has had prior allogenic or autologous stem cell transplant within < 3 months of the first infusion of imc-eb10
Beschreibung

Allogeneic hematopoietic stem cell transplant | Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C1831743
2. the patient has had an organ transplant (nonhematologic) within 3 years of study entry
Beschreibung

Organ Transplantation | Exception Hematologic Organ System

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018957
3. the patient has active central nervous system leukemia
Beschreibung

Central nervous system leukaemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1332884
4. the patient has extramedullary disease without peripheral/and or bone marrow involvement
Beschreibung

Disease Extramedullary | Peripheral Blood Involvement Absent | Bone Marrow Involvement Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1517060
UMLS CUI [2,1]
C1518996
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1517677
UMLS CUI [3,2]
C0332197
5. the patient is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. a patient who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study
Beschreibung

Cancer Other | Disease Free of Duration | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
6. the patient is currently receiving antileukemia therapy. concurrent treatment with hydroxyurea is permitted
Beschreibung

Antileukemic Agent | Hydroxyurea allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0596112
UMLS CUI [2,1]
C0020402
UMLS CUI [2,2]
C0683607
7. the patient has uncontrolled intercurrent illness as specified in the study entry criteria
Beschreibung

Comorbidity Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
8. the patient is receiving chronic steroid or other immunosuppressive medications. occasional use of steroid-containing medications, eg, for asthma exacerbation or for skin lesions, is permitted
Beschreibung

STEROID TREATMENT CHRONIC | Immunosuppressive Agents chronic | Steroid use Exacerbation of asthma allowed | Steroid use Skin lesion allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0749016
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0281991
UMLS CUI [3,2]
C0349790
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0281991
UMLS CUI [4,2]
C0037284
UMLS CUI [4,3]
C0683607
9. the patient is receiving full-dose heparin (including low molecular weight heparin) or warfarin. (the patient is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling i.v. catheters.)
Beschreibung

Heparin Dose Full | Heparin, Low-Molecular-Weight | Warfarin Dose Full

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [2]
C0019139
UMLS CUI [3,1]
C0043031
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0443225
10. the patient is pregnant (confirmed by urine or serum pregnancy test) or breast feeding
Beschreibung

Pregnancy Urine pregnancy test | Pregnancy Serum pregnancy test | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430056
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0430064
UMLS CUI [3]
C0006147
11. the patient has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of imc-eb10
Beschreibung

Monoclonal Antibodies

Datentyp

boolean

Alias
UMLS CUI [1]
C0003250
12. the patient has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins
Beschreibung

Allergic Reaction Monoclonal Antibodies | Allergic Reaction Therapeutic protein

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0003250
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0872285
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Myeloid Leukemia NCT00887926

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent adult acute myeloid leukemia Bone Marrow | Recurrent adult acute myeloid leukemia Blood | In complete remission Previous | Complete remission Previous Absent
Item
1. the patient has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission
boolean
C0278780 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0278780 (UMLS CUI [2,1])
C0005767 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0677874 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Patient Inappropriate Curative treatment Acute Myelocytic Leukemia
Item
2. the patient is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,4])
Toxicity Due to Cancer treatment | Patient recovered
Item
3. the patient has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C1115804 (UMLS CUI [2])
Major surgery Absent | Incisional biopsy Absent | Injury Absent | Cancer treatment Absent | Exception Antileukemic Agent | IMC-EB10
Item
4. the patient has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of imc-eb10
boolean
C0679637 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0184922 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3263723 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0920425 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0596112 (UMLS CUI [5,2])
C2830134 (UMLS CUI [6])
Performance status
Item
5. the patient has a performance status of 0, 1, or 2 at study entry.
boolean
C1518965 (UMLS CUI [1])
Age
Item
6. the patient is age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
7. the patient has a life expectancy of > 3 months
boolean
C0023671 (UMLS CUI [1])
Liver function | Renal function
Item
8. the patient has adequate liver and kidney function, as defined in the entry criteria
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods
Item
9. the patient is using an effective contraception (per the institutional standard), if procreative potential exists
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
10. the patient is able to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
11. the patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic hematopoietic stem cell transplant | Transplantation of autologous hematopoietic stem cell
Item
1. the patient has had prior allogenic or autologous stem cell transplant within < 3 months of the first infusion of imc-eb10
boolean
C4255274 (UMLS CUI [1])
C1831743 (UMLS CUI [2])
Organ Transplantation | Exception Hematologic Organ System
Item
2. the patient has had an organ transplant (nonhematologic) within 3 years of study entry
boolean
C0029216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018957 (UMLS CUI [2,2])
Central nervous system leukaemia
Item
3. the patient has active central nervous system leukemia
boolean
C1332884 (UMLS CUI [1])
Disease Extramedullary | Peripheral Blood Involvement Absent | Bone Marrow Involvement Absent
Item
4. the patient has extramedullary disease without peripheral/and or bone marrow involvement
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C1518996 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1517677 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cancer Other | Disease Free of Duration | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
5. the patient is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. a patient who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study
boolean
C1707251 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Antileukemic Agent | Hydroxyurea allowed
Item
6. the patient is currently receiving antileukemia therapy. concurrent treatment with hydroxyurea is permitted
boolean
C0596112 (UMLS CUI [1])
C0020402 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Comorbidity Uncontrolled
Item
7. the patient has uncontrolled intercurrent illness as specified in the study entry criteria
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
STEROID TREATMENT CHRONIC | Immunosuppressive Agents chronic | Steroid use Exacerbation of asthma allowed | Steroid use Skin lesion allowed
Item
8. the patient is receiving chronic steroid or other immunosuppressive medications. occasional use of steroid-containing medications, eg, for asthma exacerbation or for skin lesions, is permitted
boolean
C0749016 (UMLS CUI [1])
C0021081 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0281991 (UMLS CUI [3,1])
C0349790 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0281991 (UMLS CUI [4,1])
C0037284 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Heparin Dose Full | Heparin, Low-Molecular-Weight | Warfarin Dose Full
Item
9. the patient is receiving full-dose heparin (including low molecular weight heparin) or warfarin. (the patient is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling i.v. catheters.)
boolean
C0019134 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0019139 (UMLS CUI [2])
C0043031 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443225 (UMLS CUI [3,3])
Pregnancy Urine pregnancy test | Pregnancy Serum pregnancy test | Breast Feeding
Item
10. the patient is pregnant (confirmed by urine or serum pregnancy test) or breast feeding
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430064 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Monoclonal Antibodies
Item
11. the patient has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of imc-eb10
boolean
C0003250 (UMLS CUI [1])
Allergic Reaction Monoclonal Antibodies | Allergic Reaction Therapeutic protein
Item
12. the patient has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins
boolean
C1527304 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0872285 (UMLS CUI [2,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video