ID

30994

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

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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
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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])
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