ID

28082

Beschrijving

Discontinuation of Imatinib Mesylate in Patients With Chronic-Phase Chronic Myeloid Leukemia Previously Treated With Interferon-Alpha; ODM derived from: https://clinicaltrials.gov/show/NCT01073436

Link

https://clinicaltrials.gov/show/NCT01073436

Trefwoorden

Versies (3)
  1. 16-12-17 16-12-17 -
  2. 16-12-17 16-12-17 -
  3. 16-12-17 16-12-17 -
Houder van rechten

See clinicaltrials.gov

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16 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Chronic Myeloid Leukemia NCT01073436

Engels

Eligibility Chronic Myeloid Leukemia NCT01073436

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a diagnosis of philadelphia chromosome positive (ph+) chronic myeloid leukemia in chronic phase.
Beschrijving

Myeloid Leukemia Chronic-Phase Philadelphia chromosome positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0856536
2. patients must have received prior therapy with interferon-alpha for their cml, for a period of at least 2 years, and achieved at least a partial cytogenetic response on this therapy, defined as 1% - 34% ph+ cells in metaphase, present in the bone marrow.
Beschrijving

Interferon-alpha | Myeloid Leukemia, Chronic | Cytogenetic Partial Response | Bone Marrow Cell in metaphase Philadelphia chromosome positive Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C0002199
UMLS CUI [2]
C0023473
UMLS CUI [3]
C4055169
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0230520
UMLS CUI [4,3]
C0856536
UMLS CUI [4,4]
C0439165
3. patients must be actively receiving treatment for their cml with a tki (imatinib mesylate, dasatinib, nilotinib). if patients are receiving dasatinib or nilotinib, this can only be for reasons other than imatinib-resistant cml.
Beschrijving

Therapeutic procedure Chronic Myeloid Leukemia | Tyrosine kinase inhibitor | Imatinib mesylate | dasatinib | nilotinib | Exception CHRONIC MYELOID LEUKEMIA, RESISTANT TO IMATINIB

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0023473
UMLS CUI [2]
C1268567
UMLS CUI [3]
C0939537
UMLS CUI [4]
C1455147
UMLS CUI [5]
C1721377
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C4016397
4. patients must have an ongoing complete hematologic response (chr) on a tki, defined as follows:
Beschrijving

Tyrosine kinase inhibitor | Complete Hematologic Response

Datatype

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2]
C4050175
wbc ≤ 10 x 109/l.
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
platelet count < 450,000 x 109/l.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
no blasts or promyelocytes in peripheral blood.
Beschrijving

Peripheral blood Blasts Absent | Peripheral blood Promyelocytes Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0229664
UMLS CUI [1,2]
C0368761
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C0033416
UMLS CUI [2,3]
C0332197
no evidence of disease-related symptoms and extramedullary disease, including the liver and spleen.
Beschrijving

Symptoms Absent | Absence Disease Extramedullary | Liver disease Absent | Splenic Disease Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C1517060
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0037997
UMLS CUI [4,2]
C0332197
5. patients must have a complete cytogenetic response (ccyr) on a tki for a minimum of one year leading up to enrollment. complete cytogenetic response is defined as 0% ph+
Beschrijving

Tyrosine kinase inhibitor | Cytogenetic Complete Response | Philadelphia chromosome positive Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2]
C4050364
UMLS CUI [3,1]
C0856536
UMLS CUI [3,2]
C0439165
cells in metaphase, in the bone marrow and/or a negative peripheral blood fish analysis for the bcr/abl gene fusion, and an ongoing ccyr must be confirmed by bone marrow aspirate cytogenetics and/or peripheral blood fish for bcr/abl within 4 weeks of discontinuing therapy.
Beschrijving

Bone Marrow Cell in metaphase | Peripheral blood BCR-ABL Fusion Gene Negative FISH | Cytogenetic Complete Response Bone marrow aspirate Cytogenetic Analysis | Cytogenetic Complete Response Peripheral blood BCR-ABL FISH

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0230520
UMLS CUI [2,1]
C0229664
UMLS CUI [2,2]
C1835417
UMLS CUI [2,3]
C1513916
UMLS CUI [2,4]
C0162789
UMLS CUI [3,1]
C4050364
UMLS CUI [3,2]
C0857285
UMLS CUI [3,3]
C0752095
UMLS CUI [4,1]
C4050364
UMLS CUI [4,2]
C0229664
UMLS CUI [4,3]
C1835417
UMLS CUI [4,4]
C0162789
6. patients must have at least a major molecular remission on a tki for a minimum of 1 year, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment. major molecular remission is defined as ≥ 3 log reduction from a standard baseline value (equivalent to a bcr-abl/abl of ≤ 0.1%) in bcr/abl transcript by quantitative rt-pcr performed on peripheral blood or bone marrow aspirate. complete molecular remission is defined as a negative quantitative rt-pcr (qpcr) analysis for bcr/abl, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment.
Beschrijving

Tyrosine kinase inhibitor | Remission Molecular Major | Analysis Consecutive Quantity | BCR-ABL transcript Reduction Log Score | Peripheral blood RT-PCR | Bone marrow aspirate RT-PCR | Molecular Complete Response | BCR-ABL Negative RT-PCR

Datatype

boolean

Alias
UMLS CUI [1]
C1268567
UMLS CUI [2,1]
C0597370
UMLS CUI [2,2]
C1521991
UMLS CUI [2,3]
C0205164
UMLS CUI [3,1]
C0002778
UMLS CUI [3,2]
C1707491
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C1835417
UMLS CUI [4,2]
C3481430
UMLS CUI [4,3]
C0392756
UMLS CUI [4,4]
C3898579
UMLS CUI [5,1]
C0229664
UMLS CUI [5,2]
C1709846
UMLS CUI [6,1]
C0857285
UMLS CUI [6,2]
C1709846
UMLS CUI [7]
C4050308
UMLS CUI [8,1]
C1835417
UMLS CUI [8,2]
C1513916
UMLS CUI [8,3]
C1709846
7. patients must be eighteen years of age or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
8. patients must have an ecog performance status of 0-2 (appendix 13.1)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
9. all patients must be informed of the investigational nature of this study and standard alternative therapy. all patients must sign and give written informed consent in accordance with institutional and federal guidelines.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had prior progression of their cml to accelerated phase or blast crisis.
Beschrijving

Leukemia, Myeloid, Accelerated Phase | Blast Phase

Datatype

boolean

Alias
UMLS CUI [1]
C0023472
UMLS CUI [2]
C0005699
2. patients who have previously undergone hematopoietic stem cell transplantation.
Beschrijving

Hemopoietic stem cell transplant

Datatype

boolean

Alias
UMLS CUI [1]
C0472699
3. patients receiving dasatinib or nilotinib due to a prior history of imatinib-resistant cml.
Beschrijving

Dasatinib Due to CML, RESISTANT TO IMATINIB | Nilotinib Due to CML, RESISTANT TO IMATINIB

Datatype

boolean

Alias
UMLS CUI [1,1]
C1455147
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C4016397
UMLS CUI [2,1]
C1721377
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C4016397
4. patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
Beschrijving

Protocol Compliance Lacking | Unreliable behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C4061925
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Similar models

Eligibility Chronic Myeloid Leukemia NCT01073436

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Myeloid Leukemia Chronic-Phase Philadelphia chromosome positive
Item
1. patients must have a diagnosis of philadelphia chromosome positive (ph+) chronic myeloid leukemia in chronic phase.
boolean
C0023474 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
Interferon-alpha | Myeloid Leukemia, Chronic | Cytogenetic Partial Response | Bone Marrow Cell in metaphase Philadelphia chromosome positive Percentage
Item
2. patients must have received prior therapy with interferon-alpha for their cml, for a period of at least 2 years, and achieved at least a partial cytogenetic response on this therapy, defined as 1% - 34% ph+ cells in metaphase, present in the bone marrow.
boolean
C0002199 (UMLS CUI [1])
C0023473 (UMLS CUI [2])
C4055169 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0230520 (UMLS CUI [4,2])
C0856536 (UMLS CUI [4,3])
C0439165 (UMLS CUI [4,4])
Therapeutic procedure Chronic Myeloid Leukemia | Tyrosine kinase inhibitor | Imatinib mesylate | dasatinib | nilotinib | Exception CHRONIC MYELOID LEUKEMIA, RESISTANT TO IMATINIB
Item
3. patients must be actively receiving treatment for their cml with a tki (imatinib mesylate, dasatinib, nilotinib). if patients are receiving dasatinib or nilotinib, this can only be for reasons other than imatinib-resistant cml.
boolean
C0087111 (UMLS CUI [1,1])
C0023473 (UMLS CUI [1,2])
C1268567 (UMLS CUI [2])
C0939537 (UMLS CUI [3])
C1455147 (UMLS CUI [4])
C1721377 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C4016397 (UMLS CUI [6,2])
Tyrosine kinase inhibitor | Complete Hematologic Response
Item
4. patients must have an ongoing complete hematologic response (chr) on a tki, defined as follows:
boolean
C1268567 (UMLS CUI [1])
C4050175 (UMLS CUI [2])
White Blood Cell Count procedure
Item
wbc ≤ 10 x 109/l.
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 450,000 x 109/l.
boolean
C0032181 (UMLS CUI [1])
Peripheral blood Blasts Absent | Peripheral blood Promyelocytes Absent
Item
no blasts or promyelocytes in peripheral blood.
boolean
C0229664 (UMLS CUI [1,1])
C0368761 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0229664 (UMLS CUI [2,1])
C0033416 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Symptoms Absent | Absence Disease Extramedullary | Liver disease Absent | Splenic Disease Absent
Item
no evidence of disease-related symptoms and extramedullary disease, including the liver and spleen.
boolean
C1457887 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1517060 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0037997 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Tyrosine kinase inhibitor | Cytogenetic Complete Response | Philadelphia chromosome positive Percentage
Item
5. patients must have a complete cytogenetic response (ccyr) on a tki for a minimum of one year leading up to enrollment. complete cytogenetic response is defined as 0% ph+
boolean
C1268567 (UMLS CUI [1])
C4050364 (UMLS CUI [2])
C0856536 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Bone Marrow Cell in metaphase | Peripheral blood BCR-ABL Fusion Gene Negative FISH | Cytogenetic Complete Response Bone marrow aspirate Cytogenetic Analysis | Cytogenetic Complete Response Peripheral blood BCR-ABL FISH
Item
cells in metaphase, in the bone marrow and/or a negative peripheral blood fish analysis for the bcr/abl gene fusion, and an ongoing ccyr must be confirmed by bone marrow aspirate cytogenetics and/or peripheral blood fish for bcr/abl within 4 weeks of discontinuing therapy.
boolean
C0005953 (UMLS CUI [1,1])
C0230520 (UMLS CUI [1,2])
C0229664 (UMLS CUI [2,1])
C1835417 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0162789 (UMLS CUI [2,4])
C4050364 (UMLS CUI [3,1])
C0857285 (UMLS CUI [3,2])
C0752095 (UMLS CUI [3,3])
C4050364 (UMLS CUI [4,1])
C0229664 (UMLS CUI [4,2])
C1835417 (UMLS CUI [4,3])
C0162789 (UMLS CUI [4,4])
Tyrosine kinase inhibitor | Remission Molecular Major | Analysis Consecutive Quantity | BCR-ABL transcript Reduction Log Score | Peripheral blood RT-PCR | Bone marrow aspirate RT-PCR | Molecular Complete Response | BCR-ABL Negative RT-PCR
Item
6. patients must have at least a major molecular remission on a tki for a minimum of 1 year, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment. major molecular remission is defined as ≥ 3 log reduction from a standard baseline value (equivalent to a bcr-abl/abl of ≤ 0.1%) in bcr/abl transcript by quantitative rt-pcr performed on peripheral blood or bone marrow aspirate. complete molecular remission is defined as a negative quantitative rt-pcr (qpcr) analysis for bcr/abl, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment.
boolean
C1268567 (UMLS CUI [1])
C0597370 (UMLS CUI [2,1])
C1521991 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0002778 (UMLS CUI [3,1])
C1707491 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C1835417 (UMLS CUI [4,1])
C3481430 (UMLS CUI [4,2])
C0392756 (UMLS CUI [4,3])
C3898579 (UMLS CUI [4,4])
C0229664 (UMLS CUI [5,1])
C1709846 (UMLS CUI [5,2])
C0857285 (UMLS CUI [6,1])
C1709846 (UMLS CUI [6,2])
C4050308 (UMLS CUI [7])
C1835417 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C1709846 (UMLS CUI [8,3])
Age
Item
7. patients must be eighteen years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. patients must have an ecog performance status of 0-2 (appendix 13.1)
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
9. all patients must be informed of the investigational nature of this study and standard alternative therapy. all patients must sign and give written informed consent in accordance with institutional and federal guidelines.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Leukemia, Myeloid, Accelerated Phase | Blast Phase
Item
1. patients who have had prior progression of their cml to accelerated phase or blast crisis.
boolean
C0023472 (UMLS CUI [1])
C0005699 (UMLS CUI [2])
Hemopoietic stem cell transplant
Item
2. patients who have previously undergone hematopoietic stem cell transplantation.
boolean
C0472699 (UMLS CUI [1])
Dasatinib Due to CML, RESISTANT TO IMATINIB | Nilotinib Due to CML, RESISTANT TO IMATINIB
Item
3. patients receiving dasatinib or nilotinib due to a prior history of imatinib-resistant cml.
boolean
C1455147 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C4016397 (UMLS CUI [1,3])
C1721377 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C4016397 (UMLS CUI [2,3])
Protocol Compliance Lacking | Unreliable behavior
Item
4. patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
boolean
C0525058 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C4061925 (UMLS CUI [2])
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