ID

23484

Description

Responsible Party: Prof. Dr. Nikolas von Bubnoff, Mr., University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02174445 History of Changes Other Study ID Numbers: CAMN107ADE18T 2013-000077-68 ( EudraCT Number ) DRKS00006285 ( Registry Identifier: DRKS ) Study First Received: June 24, 2014 Last Updated: November 22, 2016 An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years (DECLINE) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02174445

Link

https://clinicaltrials.gov/ct2/show/NCT02174445

Keywords

Versions (1)
  1. 7/7/17 7/7/17 -
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July 7, 2017

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Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT02174445 DRKS00006285

English

Eligibility Chronic Myeloid Leukemia NCT02174445 DRKS00006285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. Male or female patients aged >=18 years (without upper limit of age)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. ECOG performance status of 0 to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. CML in chronic phase, with chronic phase defined as blasts < 15% in blood and/or bone marrow and peripheral blood basophils < 20% and platelets ≥ 100 G/L
Description

Chronic Myeloid Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023473
5. Pretreatment with Imatinib with a treatment duration of at least 18 months at a dosage of 400 to 800 mg daily
Description

Imatinib

Data type

boolean

Alias
UMLS CUI [1]
C0935989
6. Major molecular response (MMR) without molecular response ≥ 4.5 log (MR4.5), i.e. BCR-ABL>0.0032% and ≤0.1% IS confirmed by central la-boratory at screening will be required for randomisation
Description

Major molecular response

Data type

boolean

Alias
UMLS CUI [1]
C4049637
7. Patients must have a serum Creatinine of ≤ 1.5 x ULN, SGOT ≤ 1.5 x ULN, total bilirubin ≤ 1.5 x ULN (except known M. Gilbert), and Lipase ≤ 1.5 x ULN
Description

Creatinine, SGOT, total Bilirubin, Lipase

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0373670
8. Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months, must have a negative serum pregnancy test during screening period. Male and fe-male patients of reproductive potential must agree to employ highly ef-fective methods of birth control throughout the study and for up to 3 months following discontinuation of study drug. Appropriate methods are e.g. a highly effective method of first choice, i.e. a method with a low failure rate (less than 1% per year) like sexual abstinence, com-bined oral contraceptives, implants, injectable, some Intra Uterine Devices (IUDs), vasectomized partner, in combination with a method of second choice like condom, diaphragm, or cup pessary with spermicidal foam/gel/film/cream/suppository.
Description

Pregnancy Test, Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Any previous treatment for CML other than Hydroxyurea, Imatinib or Interferon alpha
Description

Prior Therapy for CML

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0023473
2. Evidence of features of accelerated or blast phase at any time
Description

Accelerated or blast phase

Data type

boolean

Alias
UMLS CUI [1]
C0457343
UMLS CUI [2]
C0005699
3. Previous loss of hematologic or cytogenetic response
Description

Hematologic or cytogenetic response

Data type

boolean

Alias
UMLS CUI [1]
C4054793
UMLS CUI [2]
C4055168
4. Concomitant medications known to be strong inducers or inhibitors of P450 Isoenzyme CYP3A4
Description

Inducers or inhibitors of P450 Isoenzyme CYP3A4

Data type

boolean

Alias
UMLS CUI [1]
C3830625
UMLS CUI [2]
C3850053
5. Finding of a secondary BCR-ABL resistance mutation at any time
Description

BCR-ABL

Data type

boolean

Alias
UMLS CUI [1]
C1835417
6. History of intolerance to Imatinib that required treatment interruption longer than 4 weeks (cumulative) or dose reductions to less than 400 mg daily for longer than 4 weeks (cumulative) during the last 12 months before informed consent
Description

Intolerance to Imatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0935989
7. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant
Description

Bone marrow transplant or stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C0472699
8. Patients unwilling to or unable to comply with the planned therapeutic intervention or to comply with the study treatment visits including blood sample collection within the protocol
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
9. History of pancreatitis, chronic inflammatory diseases or autoimmune diseases
Description

Pancreatitis, chronic inflammatory diseases or autoimmune diseases

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C1290886
UMLS CUI [3]
C0004364
10. Patients who underwent solid organ transplantation
Description

Organ transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
11. Impaired cardiac function, including any of the following: - History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemi block, bifascicular block in screening ECG - Use of a cardiac pacemaker - ST depression of > 1mm in 2 or more leads and/or T wave inver-sions in 2 or more contiguous leads in screening ECG - Congenital Long QT Syndrome - QTc> 450 msec in the screening ECG - QT prolonging concomitant medication - History of or presence of significant ventricular or atrial tachy-arrhythmia in screening ECG - History of or presence of clinically significant resting bradycardia (< 50 beats per minute) - Myocardial infarction within 12 months prior to informed consent - Unstable angina diagnosed or treated during the past 12 months before informed consent - Other clinically significant heart disease (e.g., congestive heart fail-ure, uncontrolled hypertension, history of labile hypertension)
Description

Cardiac Function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
12. Known HIV and/or hepatitis B or C infection (testing is not mandatory)
Description

HIV, HBV, HCV

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
13. Other malignancies within the past 3 years before informed consent except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
14. Women who are pregnant or breast feeding
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
15. Male/female patients of reproductive potential unwilling to practice a highly effective method of birth control
Description

Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
16. History of noncompliance to medical regimens
Description

Compliance History

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0019664
17. Treatment with another investigational product during this study or during the last 30 days prior to informed consent
Description

Experimental Drug

Data type

boolean

Alias
UMLS CUI [1]
C0304229
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Similar models

Eligibility Chronic Myeloid Leukemia NCT02174445 DRKS00006285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
1. Signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. Male or female patients aged >=18 years (without upper limit of age)
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ECOG performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
Chronic Myeloid Leukemia
Item
4. CML in chronic phase, with chronic phase defined as blasts < 15% in blood and/or bone marrow and peripheral blood basophils < 20% and platelets ≥ 100 G/L
boolean
C0023473 (UMLS CUI [1])
Imatinib
Item
5. Pretreatment with Imatinib with a treatment duration of at least 18 months at a dosage of 400 to 800 mg daily
boolean
C0935989 (UMLS CUI [1])
Major molecular response
Item
6. Major molecular response (MMR) without molecular response ≥ 4.5 log (MR4.5), i.e. BCR-ABL>0.0032% and ≤0.1% IS confirmed by central la-boratory at screening will be required for randomisation
boolean
C4049637 (UMLS CUI [1])
Creatinine, SGOT, total Bilirubin, Lipase
Item
7. Patients must have a serum Creatinine of ≤ 1.5 x ULN, SGOT ≤ 1.5 x ULN, total bilirubin ≤ 1.5 x ULN (except known M. Gilbert), and Lipase ≤ 1.5 x ULN
boolean
C0201976 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0373670 (UMLS CUI [4])
Pregnancy Test, Contraceptive Methods
Item
8. Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months, must have a negative serum pregnancy test during screening period. Male and fe-male patients of reproductive potential must agree to employ highly ef-fective methods of birth control throughout the study and for up to 3 months following discontinuation of study drug. Appropriate methods are e.g. a highly effective method of first choice, i.e. a method with a low failure rate (less than 1% per year) like sexual abstinence, com-bined oral contraceptives, implants, injectable, some Intra Uterine Devices (IUDs), vasectomized partner, in combination with a method of second choice like condom, diaphragm, or cup pessary with spermicidal foam/gel/film/cream/suppository.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Prior Therapy for CML
Item
1. Any previous treatment for CML other than Hydroxyurea, Imatinib or Interferon alpha
boolean
C1514463 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
Accelerated or blast phase
Item
2. Evidence of features of accelerated or blast phase at any time
boolean
C0457343 (UMLS CUI [1])
C0005699 (UMLS CUI [2])
Hematologic or cytogenetic response
Item
3. Previous loss of hematologic or cytogenetic response
boolean
C4054793 (UMLS CUI [1])
C4055168 (UMLS CUI [2])
Inducers or inhibitors of P450 Isoenzyme CYP3A4
Item
4. Concomitant medications known to be strong inducers or inhibitors of P450 Isoenzyme CYP3A4
boolean
C3830625 (UMLS CUI [1])
C3850053 (UMLS CUI [2])
BCR-ABL
Item
5. Finding of a secondary BCR-ABL resistance mutation at any time
boolean
C1835417 (UMLS CUI [1])
Intolerance to Imatinib
Item
6. History of intolerance to Imatinib that required treatment interruption longer than 4 weeks (cumulative) or dose reductions to less than 400 mg daily for longer than 4 weeks (cumulative) during the last 12 months before informed consent
boolean
C1744706 (UMLS CUI [1,1])
C0935989 (UMLS CUI [1,2])
Bone marrow transplant or stem cell transplant
Item
7. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant
boolean
C0005961 (UMLS CUI [1])
C0472699 (UMLS CUI [2])
Compliance
Item
8. Patients unwilling to or unable to comply with the planned therapeutic intervention or to comply with the study treatment visits including blood sample collection within the protocol
boolean
C1321605 (UMLS CUI [1])
Pancreatitis, chronic inflammatory diseases or autoimmune diseases
Item
9. History of pancreatitis, chronic inflammatory diseases or autoimmune diseases
boolean
C0030305 (UMLS CUI [1])
C1290886 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
Organ transplantation
Item
10. Patients who underwent solid organ transplantation
boolean
C0029216 (UMLS CUI [1])
Cardiac Function
Item
11. Impaired cardiac function, including any of the following: - History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemi block, bifascicular block in screening ECG - Use of a cardiac pacemaker - ST depression of > 1mm in 2 or more leads and/or T wave inver-sions in 2 or more contiguous leads in screening ECG - Congenital Long QT Syndrome - QTc> 450 msec in the screening ECG - QT prolonging concomitant medication - History of or presence of significant ventricular or atrial tachy-arrhythmia in screening ECG - History of or presence of clinically significant resting bradycardia (< 50 beats per minute) - Myocardial infarction within 12 months prior to informed consent - Unstable angina diagnosed or treated during the past 12 months before informed consent - Other clinically significant heart disease (e.g., congestive heart fail-ure, uncontrolled hypertension, history of labile hypertension)
boolean
C0232164 (UMLS CUI [1])
HIV, HBV, HCV
Item
12. Known HIV and/or hepatitis B or C infection (testing is not mandatory)
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Malignant Neoplasms
Item
13. Other malignancies within the past 3 years before informed consent except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
Gynaecological Status
Item
14. Women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive Methods
Item
15. Male/female patients of reproductive potential unwilling to practice a highly effective method of birth control
boolean
C0700589 (UMLS CUI [1])
Compliance History
Item
16. History of noncompliance to medical regimens
boolean
C1321605 (UMLS CUI [1,1])
C0019664 (UMLS CUI [1,2])
Experimental Drug
Item
17. Treatment with another investigational product during this study or during the last 30 days prior to informed consent
boolean
C0304229 (UMLS CUI [1])
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