ID

43233

Description

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

Keywords

Versions (3)
  1. 8/3/15 8/3/15 - Julian Varghese
  2. 8/3/15 8/3/15 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02034227

English

Eligibility Acute Myeloid Leukemia NCT02034227

1 forms  
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02034227
    1. Eligibility Acute Myeloid Leukemia NCT02034227
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

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

Data type

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).
Description

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

Data type

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).
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0427541
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0020402
have adequate hepatic function and renal function
Description

have adequate hepatic function and renal function

Data type

boolean

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

life expectancy

Data type

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
Description

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

Data type

boolean

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

Exclusion Criteria

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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.
Description

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.

Data type

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%.
Description

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

Data type

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.
Description

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

Data type

boolean

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

hyperleukocytosis (blast counts >30 000/mm3).

Data type

boolean

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

history of allogeneic stem cell or solid organ transplantation.

Data type

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.
Description

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

Data type

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.
Description

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.

Data type

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.
Description

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

Data type

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.
Description

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

Data type

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).
Description

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

Data type

boolean

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

are pregnant or breast-feeding.

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT02034227

1 forms
  1. StudyEvent: Eligibility Acute Myeloid Leukemia NCT02034227
    1. Eligibility Acute Myeloid Leukemia NCT02034227
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0427541 (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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