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])
ID.15
Item
1. patients who have had prior progression of their cml to accelerated phase or blast crisis.
boolean
Hemopoietic stem cell transplant
Item
2. patients who have previously undergone hematopoietic stem cell transplantation.
boolean
C0472699 (UMLS CUI [1])
ID.17
Item
3. patients receiving dasatinib or nilotinib due to a prior history of imatinib-resistant cml.
boolean
ID.18
Item
4. patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
boolean