ID

20176

Beschreibung

Safety and Tolerability Study of INNO-406 to Treat Chronic Myeloid Leukemia or Acute Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00352677

Link

https://clinicaltrials.gov/show/NCT00352677

Stichworte

Versionen (1)
  1. 09.02.17 09.02.17 -
Hochgeladen am

9. Februar 2017

DOI

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Eligibility Chronic Myeloid Leukemia NCT00352677

Englisch

Eligibility Chronic Myeloid Leukemia NCT00352677

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have a confirmed diagnosis of ph+ all or cml in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
Beschreibung

Philadelphia chromosome-positive acute lymphoblastic leukemia Chronic phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Accelerated phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Blast Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib Resistant | Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib intolerant | Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase | Philadelphia chromosome positive chronic myelogenous leukemia Accelerated phase | Philadelphia chromosome positive chronic myelogenous leukemia Blast Phase | Philadelphia chromosome positive chronic myelogenous leukemia Imatinib Resistant | Philadelphia chromosome positive chronic myelogenous leukemia Imatinib intolerant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960397
UMLS CUI [1,2]
C0457343
UMLS CUI [2,1]
C1960397
UMLS CUI [2,2]
C0457345
UMLS CUI [3,1]
C1960397
UMLS CUI [3,2]
C0005699
UMLS CUI [4,1]
C1960397
UMLS CUI [4,2]
C0935989
UMLS CUI [4,3]
C0332325
UMLS CUI [5,1]
C1960397
UMLS CUI [5,2]
C0935989
UMLS CUI [5,3]
C0231200
UMLS CUI [6,1]
C0279543
UMLS CUI [6,2]
C0457343
UMLS CUI [7,1]
C0279543
UMLS CUI [7,2]
C0457345
UMLS CUI [8,1]
C0279543
UMLS CUI [8,2]
C0005699
UMLS CUI [9,1]
C0279543
UMLS CUI [9,2]
C0935989
UMLS CUI [9,3]
C0332325
UMLS CUI [10,1]
C0279543
UMLS CUI [10,2]
C0935989
UMLS CUI [10,3]
C0231200
2. be ≥18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. have an eastern cooperative oncology group (ecog) performance status of ≤2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. have an estimated life expectancy of ≥12 weeks.
Beschreibung

Life Expectancy Estimated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0750572
5. be male or non-pregnant, non-lactating female. patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
Beschreibung

Pregnancy | Breast Feeding | Fertility Barrier Contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0015895
UMLS CUI [3,2]
C0004764
6. have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
7. have acceptable pre-treatment clinical laboratory results.
Beschreibung

Normal Laboratory Test Result Clinical pre treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438214
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C2709094
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
Beschreibung

Chemotherapy | hydroxyurea | Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0020402
UMLS CUI [3]
C0001617
2. have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
Beschreibung

Imatinib | Imatinib Adverse effects Recovered

Datentyp

boolean

Alias
UMLS CUI [1]
C0935989
UMLS CUI [2,1]
C0935989
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C0521108
3. have impaired cardiac function.
Beschreibung

Decreased cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232166
4. have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
Beschreibung

Sepsis Uncontrolled | Sepsis Opportunistic | Sepsis Life-threatening | Sepsis Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0029118
UMLS CUI [3,1]
C0243026
UMLS CUI [3,2]
C2826244
UMLS CUI [4,1]
C0243026
UMLS CUI [4,2]
C2826293
5. have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
Beschreibung

Liver disease Clinical Significance Neoplasm Relationship | Kidney Disease Clinical Significance Neoplasm Relationship | Chronic liver disease Clinical Significance Neoplasm Relationship | Chronic Kidney Disease Clinical Significance Neoplasm Relationship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0027651
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0027651
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C0341439
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0027651
UMLS CUI [3,4]
C0439849
UMLS CUI [4,1]
C1561643
UMLS CUI [4,2]
C2826293
UMLS CUI [4,3]
C0027651
UMLS CUI [4,4]
C0439849
6. have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
Beschreibung

Abnormal digestive tract function Drug absorption Changing Significant | Vomiting Uncontrolled | Ulcerative Colitis | Malabsorption | Small intestine excision

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232459
UMLS CUI [1,2]
C0678745
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0750502
UMLS CUI [2,1]
C0042963
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0009324
UMLS CUI [4]
C3714745
UMLS CUI [5]
C0192601
7. are pregnant or lactating.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
Beschreibung

Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C3274571
9. have not recovered from acute toxicity of all previous therapy prior to enrollment.
Beschreibung

Toxic effect Recovered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0521108
10. have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
Beschreibung

Comorbidity Severe predisposing Safety Risk | Comorbidity Severe Protocol Compliance Limited | Medical condition Uncontrolled predisposing Safety Risk | Medical condition Uncontrolled Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0231203
UMLS CUI [1,4]
C0036043
UMLS CUI [1,5]
C0035647
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0205082
UMLS CUI [3,4]
C0231203
UMLS CUI [3,5]
C0036043
UMLS CUI [3,6]
C0035647
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0205082
UMLS CUI [4,4]
C0525058
UMLS CUI [4,5]
C0439801
11. have a history of another primary malignancy that is currently clinically significant or requires active intervention.
Beschreibung

Primary tumor Clinical Significance | Primary tumor Requirement Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0184661
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Ähnliche Modelle

Eligibility Chronic Myeloid Leukemia NCT00352677

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Philadelphia chromosome-positive acute lymphoblastic leukemia Chronic phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Accelerated phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Blast Phase | Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib Resistant | Philadelphia chromosome-positive acute lymphoblastic leukemia Imatinib intolerant | Philadelphia chromosome positive chronic myelogenous leukemia Chronic phase | Philadelphia chromosome positive chronic myelogenous leukemia Accelerated phase | Philadelphia chromosome positive chronic myelogenous leukemia Blast Phase | Philadelphia chromosome positive chronic myelogenous leukemia Imatinib Resistant | Philadelphia chromosome positive chronic myelogenous leukemia Imatinib intolerant
Item
1. have a confirmed diagnosis of ph+ all or cml in chronic, accelerated, or blastic phases that are either resistant to or intolerant of imatinib therapy.
boolean
C1960397 (UMLS CUI [1,1])
C0457343 (UMLS CUI [1,2])
C1960397 (UMLS CUI [2,1])
C0457345 (UMLS CUI [2,2])
C1960397 (UMLS CUI [3,1])
C0005699 (UMLS CUI [3,2])
C1960397 (UMLS CUI [4,1])
C0935989 (UMLS CUI [4,2])
C0332325 (UMLS CUI [4,3])
C1960397 (UMLS CUI [5,1])
C0935989 (UMLS CUI [5,2])
C0231200 (UMLS CUI [5,3])
C0279543 (UMLS CUI [6,1])
C0457343 (UMLS CUI [6,2])
C0279543 (UMLS CUI [7,1])
C0457345 (UMLS CUI [7,2])
C0279543 (UMLS CUI [8,1])
C0005699 (UMLS CUI [8,2])
C0279543 (UMLS CUI [9,1])
C0935989 (UMLS CUI [9,2])
C0332325 (UMLS CUI [9,3])
C0279543 (UMLS CUI [10,1])
C0935989 (UMLS CUI [10,2])
C0231200 (UMLS CUI [10,3])
Age
Item
2. be ≥18 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. have an eastern cooperative oncology group (ecog) performance status of ≤2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy Estimated
Item
4. have an estimated life expectancy of ≥12 weeks.
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Fertility Barrier Contraception
Item
5. be male or non-pregnant, non-lactating female. patients who are fertile must agree to use an effective barrier method of contraception while on therapy and for 90 days following discontinuation of study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
6. have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Normal Laboratory Test Result Clinical pre treatment
Item
7. have acceptable pre-treatment clinical laboratory results.
boolean
C0438214 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | hydroxyurea | Adrenal Cortex Hormones
Item
1. have received chemotherapy ≤1 week from the start of therapy, with the exception of hydroxyurea and corticosteroids.
boolean
C0392920 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Imatinib | Imatinib Adverse effects Recovered
Item
2. have received imatinib ≤3 days prior to enrollment or have not recovered from side effects of imatinib therapy.
boolean
C0935989 (UMLS CUI [1])
C0935989 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0521108 (UMLS CUI [2,3])
Decreased cardiac function
Item
3. have impaired cardiac function.
boolean
C0232166 (UMLS CUI [1])
Sepsis Uncontrolled | Sepsis Opportunistic | Sepsis Life-threatening | Sepsis Clinical Significance
Item
4. have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment.
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0243026 (UMLS CUI [2,1])
C0029118 (UMLS CUI [2,2])
C0243026 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
C0243026 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Liver disease Clinical Significance Neoplasm Relationship | Kidney Disease Clinical Significance Neoplasm Relationship | Chronic liver disease Clinical Significance Neoplasm Relationship | Chronic Kidney Disease Clinical Significance Neoplasm Relationship
Item
5. have clinically significant acute or chronic liver or renal disease considered unrelated to tumor.
boolean
C0023895 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0022658 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0341439 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C1561643 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C0027651 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Abnormal digestive tract function Drug absorption Changing Significant | Vomiting Uncontrolled | Ulcerative Colitis | Malabsorption | Small intestine excision
Item
6. have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection).
boolean
C0232459 (UMLS CUI [1,1])
C0678745 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
C0042963 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009324 (UMLS CUI [3])
C3714745 (UMLS CUI [4])
C0192601 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
7. are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorder Interferes with Informed Consent | Mental disorder Interferes with Study Subject Participation Status | Mental disorder Interferes with Follow-up
Item
8. have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
Toxic effect Recovered
Item
9. have not recovered from acute toxicity of all previous therapy prior to enrollment.
boolean
C0600688 (UMLS CUI [1,1])
C0521108 (UMLS CUI [1,2])
Comorbidity Severe predisposing Safety Risk | Comorbidity Severe Protocol Compliance Limited | Medical condition Uncontrolled predisposing Safety Risk | Medical condition Uncontrolled Protocol Compliance Limited
Item
10. have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0231203 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0035647 (UMLS CUI [1,5])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0231203 (UMLS CUI [3,4])
C0036043 (UMLS CUI [3,5])
C0035647 (UMLS CUI [3,6])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C0439801 (UMLS CUI [4,5])
Primary tumor Clinical Significance | Primary tumor Requirement Intervention
Item
11. have a history of another primary malignancy that is currently clinically significant or requires active intervention.
boolean
C0677930 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
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