ID

11787

Beschreibung

Safety, Tolerability Study of SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia; ODM derived from: http://clinicaltrials.gov/show/NCT02034227

Link

http://clinicaltrials.gov/show/NCT02034227

Stichworte

Versionen (3)
  1. 03.08.15 03.08.15 - Julian Varghese
  2. 03.08.15 03.08.15 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

3. August 2015

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02034227

Englisch

Eligibility Acute Myeloid Leukemia NCT02034227

1 Formulare  
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02034227
    1. Eligibility Acute Myeloid Leukemia NCT02034227
Inclusion Criteria
Beschreibung

Inclusion Criteria

male or female greater than or equal to 18 years of age
Beschreibung

male or female greater than or equal to 18 years of age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
have one of the following disease states: acute myeloid leukemia (aml) (age <60 years) with relapsed/refractory disease; chronic lymphocytic leukemia (cll) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
Beschreibung

have one of the following disease states: acute myeloid leukemia (aml) (age <60 years) with relapsed/refractory disease; chronic lymphocytic leukemia (cll) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0035020
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0278787
UMLS CUI [4,2]
C0332293
UMLS CUI [4,3]
C0059985
UMLS CUI [5,1]
C0023434
UMLS CUI [5,2]
C0332293
UMLS CUI [5,3]
C0002073
are recovered from the acute adverse effects of prior therapies (excluding alopecia and grade ≤2 neuropathy).
Beschreibung

are recovered from the acute adverse effects of prior therapies (excluding alopecia and grade ≤2 neuropathy).

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0879626
UMLS CUI [2]
C0002170
UMLS CUI [3]
C0442874
have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
Beschreibung

have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1318023
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0020402
have adequate hepatic function and renal function
Beschreibung

have adequate hepatic function and renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C1848676
UMLS CUI [2]
C0232805
have an estimated life expectancy of >3 months
Beschreibung

life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
female subject must have a negative serum pregnancy result within 7 days before the start of the study; both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment
Beschreibung

female subject must have a negative serum pregnancy result within 7 days before the start of the study; both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0430064
Exclusion Criteria
Beschreibung

Exclusion Criteria

are eligible for any standard therapy known to be life prolonging or life saving
Beschreibung

are eligible for any standard therapy known to be life prolonging or life saving

Datentyp

boolean

have diagnosis of aml french-american-british (fab) classification (fab) m3 (acute promyelocytic leukemia (apl))
Beschreibung

have diagnosis of aml french-american-british (fab) classification (fab) m3 (acute promyelocytic leukemia (apl))

Datentyp

boolean

Alias
UMLS CUI [1]
C0457329
are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
Beschreibung

are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.

Datentyp

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
UMLS CUI [5]
C0279025
have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.
Beschreibung

have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.

Datentyp

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0020402
prior radiation therapy with volume of bone marrow treated over 25%.
Beschreibung

prior radiation therapy with volume of bone marrow treated over 25%.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of sg2000.
Beschreibung

use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of sg2000.

Datentyp

boolean

Alias
UMLS CUI [1]
C0455630
UMLS CUI [2]
C0149783
hyperleukocytosis (blast counts >30 000/mm3).
Beschreibung

hyperleukocytosis (blast counts >30 000/mm3).

Datentyp

boolean

Alias
UMLS CUI [1]
C3805210
history of allogeneic stem cell or solid organ transplantation.
Beschreibung

history of allogeneic stem cell or solid organ transplantation.

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C2242529
positive serology for human immunodeficiency virus (hiv), hepatitis b or hepatitis c or have hiv-aids, or active hepatitis b or c.
Beschreibung

positive serology for human immunodeficiency virus (hiv), hepatitis b or hepatitis c or have hiv-aids, or active hepatitis b or c.

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0744837
UMLS CUI [3]
C0850489
UMLS CUI [4]
C0001175
history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
Beschreibung

history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.

Datentyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0007099
UMLS CUI [3,1]
C0007114
UMLS CUI [3,2]
C1518408
have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
Beschreibung

have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1549479
UMLS CUI [1,3]
C0012634
have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.
Beschreibung

have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1549479
UMLS CUI [1,3]
C0004936
have persistent grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
Beschreibung

have persistent grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).

Datentyp

boolean

Alias
UMLS CUI [1]
C2826262
UMLS CUI [2]
C0002170
UMLS CUI [3]
C0031117
are pregnant or breast-feeding.
Beschreibung

are pregnant or breast-feeding.

Datentyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT02034227

1 Formulare
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02034227
    1. Eligibility Acute Myeloid Leukemia NCT02034227
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Age
Item
male or female greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute; Unresponsive to Treatment | Leukemia, Myelocytic, Acute; Relapse | Age | chronic myelogenous leukemia in relapse; Treated with; fludarabine | Chronic Lymphocytic Leukemia; Treated with; Alkylating Agents
Item
have one of the following disease states: acute myeloid leukemia (aml) (age <60 years) with relapsed/refractory disease; chronic lymphocytic leukemia (cll) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0278787 (UMLS CUI [4,1])
C0332293 (UMLS CUI [4,2])
C0059985 (UMLS CUI [4,3])
C0023434 (UMLS CUI [5,1])
C0332293 (UMLS CUI [5,2])
C0002073 (UMLS CUI [5,3])
Recovery from ; Alopecia Adverse Event | Neuropathy; Adverse event
Item
are recovered from the acute adverse effects of prior therapies (excluding alopecia and grade ≤2 neuropathy).
boolean
C2004454 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0002170 (UMLS CUI [2])
C0442874 (UMLS CUI [3])
Blast cell count measurement; Controlled by; hydroxyurea
Item
have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
boolean
C1318023 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0020402 (UMLS CUI [1,3])
adequate hepatic function; renal function
Item
have adequate hepatic function and renal function
boolean
C1848676 (UMLS CUI [1])
C0232805 (UMLS CUI [2])
life expectancy
Item
have an estimated life expectancy of >3 months
boolean
C0023671 (UMLS CUI [1])
Contraception status | serum pregnancy test
Item
female subject must have a negative serum pregnancy result within 7 days before the start of the study; both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment
boolean
C0420837 (UMLS CUI [1])
C0430064 (UMLS CUI [2])
Eligibility for lifesaving or life-prolonging standard therapy
Item
are eligible for any standard therapy known to be life prolonging or life saving
boolean
FAB type M3
Item
have diagnosis of aml french-american-british (fab) classification (fab) m3 (acute promyelocytic leukemia (apl))
boolean
C0457329 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Hormone Therapy
Item
are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Chemotherapy | Hormone Therapy | Immunotherapy | hydroxyurea
Item
have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.
boolean
C3665472 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0020402 (UMLS CUI [4])
Therapeutic radiology procedure; Bone Marrow; Percent (qualifier value)
Item
prior radiation therapy with volume of bone marrow treated over 25%.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
History of immunosuppressive therapy | Steroid therapy
Item
use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of sg2000.
boolean
C0455630 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
hyperleukocytosis
Item
hyperleukocytosis (blast counts >30 000/mm3).
boolean
C3805210 (UMLS CUI [1])
Organ Transplantation | Allogeneic Stem Cell Transplantation
Item
history of allogeneic stem cell or solid organ transplantation.
boolean
C0029216 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
HIV Seropositivity | hepatitis b serology | hepatitis C serology test | Acquired Immunodeficiency Syndrome
Item
positive serology for human immunodeficiency virus (hiv), hepatitis b or hepatitis c or have hiv-aids, or active hepatitis b or c.
boolean
C0019699 (UMLS CUI [1])
C0744837 (UMLS CUI [2])
C0850489 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
invasive cancer | Carcinoma in Situ | Malignant neoplasm of skin; Nonmelanomatous
Item
history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
boolean
C0677898 (UMLS CUI [1])
C0007099 (UMLS CUI [2])
C0007114 (UMLS CUI [3,1])
C1518408 (UMLS CUI [3,2])
Study Subject Participation Status; limited by - ActRelationshipType; Disease
Item
have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1549479 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Informed Consent; limited by - ActRelationshipType; Mental disorders
Item
have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.
boolean
C0021430 (UMLS CUI [1,1])
C1549479 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Toxicity Grade | Alopecia | Peripheral Neuropathy
Item
have persistent grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
boolean
C2826262 (UMLS CUI [1])
C0002170 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
Patient currently pregnant | Breast Feeding
Item
are pregnant or breast-feeding.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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