ID

13563

Descripción

Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01420926

Link

https://clinicaltrials.gov/show/NCT01420926

Palabras clave

Versiones (1)
  1. 16/2/16 16/2/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

16 de febrero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01420926

Inglés

Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01420926

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal pathologic diagnosis of aml (>= 20% blasts in the bone marrow based on world health organization [who] criteria) excluding: acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (pml)-retinoic acid receptor, alpha (rara) acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (runx1)-runt-related transcription factor 1; translocated to, 1 (runxt1) as determined by the ohio state university (osu) molecular reference laboratory, per cancer and leukemia group b (calgb) 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the fms-related tyrosine kinase 3 (flt3) mutation and core-binding factor (cbf) molecular screening results from calgb 20202 acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); core-binding factor, beta subunit (cbfb)-myosin, heavy chain 11, smooth muscle (myh11) as determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202
Descripción

unequivocal pathologic diagnosis of aml (>= 20% blasts in the bone marrow based on world health organization [who] criteria) excluding: acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (pml)-retinoic acid receptor, alpha (rara) acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (runx1)-runt-related transcription factor 1; translocated to, 1 (runxt1) as determined by the ohio state university (osu) molecular reference laboratory, per cancer and leukemia group b (calgb) 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the fms-related tyrosine kinase 3 (flt3) mutation and core-binding factor (cbf) molecular screening results from calgb 20202 acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); core-binding factor, beta subunit (cbfb)-myosin, heavy chain 11, smooth muscle (myh11) as determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023487
UMLS CUI [3]
C1709412
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0232174
UMLS CUI [6]
C1518965
absence of flt3 mutation (internal tandem duplication [itd] or point mutation) determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202
Descripción

absence of flt3 mutation (internal tandem duplication [itd] or point mutation) determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348501
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232174
UMLS CUI [4]
C1518965
no prior treatment for aml except: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only) growth factor/cytokine support
Descripción

no prior treatment for aml except: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only) growth factor/cytokine support

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0023416
UMLS CUI [2,2]
C0013956
UMLS CUI [3,1]
C0020402
UMLS CUI [3,2]
C0013956
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0282548
UMLS CUI [5]
C0018284
UMLS CUI [6]
C0199974
aml patients with an antecedent hematologic disorder (ahd) or myelodysplastic syndrome (mds) are eligible for this trial provided that they have not received treatment for their ahd or mds with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was >= 90 days prior to starting 11002
Descripción

aml patients with an antecedent hematologic disorder (ahd) or myelodysplastic syndrome (mds) are eligible for this trial provided that they have not received treatment for their ahd or mds with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was >= 90 days prior to starting 11002

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0332152
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C0392920
aml patients with therapy-related myeloid neoplasms (t-mn) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for > 6 months
Descripción

aml patients with therapy-related myeloid neoplasms (t-mn) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for > 6 months

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2939461
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2924519
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
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Similar models

Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01420926

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
unequivocal pathologic diagnosis of aml (>= 20% blasts in the bone marrow based on world health organization [who] criteria) excluding: acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (pml)-retinoic acid receptor, alpha (rara) acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (runx1)-runt-related transcription factor 1; translocated to, 1 (runxt1) as determined by the ohio state university (osu) molecular reference laboratory, per cancer and leukemia group b (calgb) 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the fms-related tyrosine kinase 3 (flt3) mutation and core-binding factor (cbf) molecular screening results from calgb 20202 acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); core-binding factor, beta subunit (cbfb)-myosin, heavy chain 11, smooth muscle (myh11) as determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202
boolean
C0023467 (UMLS CUI [1])
C0023487 (UMLS CUI [2])
C1709412 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C1518965 (UMLS CUI [6])
flt3 mutation
Item
absence of flt3 mutation (internal tandem duplication [itd] or point mutation) determined by the osu molecular reference laboratory, per calgb 20202; however patients who (1) are >= 75 years; and/or (2) have an ejection fraction of < 40%; and/or (3) have a performance status of > 2, may be registered to calgb 20202 and registered and treated on calgb 11002 prior to receiving the flt3 mutation and cbf molecular screening results from calgb 20202
boolean
C2348501 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
C1518965 (UMLS CUI [4])
no prior treatment
Item
no prior treatment for aml except: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only) growth factor/cytokine support
boolean
C1514463 (UMLS CUI [1])
C0023416 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0020402 (UMLS CUI [3,1])
C0013956 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0282548 (UMLS CUI [4,2])
C0018284 (UMLS CUI [5])
C0199974 (UMLS CUI [6])
antecedent hematologic disorder (ahd) or myelodysplastic syndrome (mds)
Item
aml patients with an antecedent hematologic disorder (ahd) or myelodysplastic syndrome (mds) are eligible for this trial provided that they have not received treatment for their ahd or mds with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was >= 90 days prior to starting 11002
boolean
C0018939 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
therapy-related myeloid neoplasms
Item
aml patients with therapy-related myeloid neoplasms (t-mn) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for > 6 months
boolean
C2939461 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2924519 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
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