[c09aa8]: / clusters / 9knumclustersv2 / clust_2496.txt

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BCR-ABL-rearranged (Ph+) ALL
Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations
Patients with BCR-ABL fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day Induction
Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog (ABL)+ ALL are not eligible
Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients with Burkitt's (L) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have relapsed or refractory diagnoses\r\n* NOTE: Relapsed/refractory Ph-positive patients or Ph-like patients with dasatinib-sensitive mutations or kinase fusions who have previous exposure to either dasatinib or another nd or rd generation TKI will begin protocol therapy with Cohort : re-induction cycle
Patients must have a diagnosis of Philadelphia chromosome negative ALL or Ph chromosome positive ALL by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR); patients will be registered to receive treatment in either Cohort (ph-) or Cohort (Ph+ or Ph-like DSMKF) based on these results; diagnostic specimens must be submitted to the sites local Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory and results of tests (cytogenetics, FISH or PCR) must confirm Ph status prior to registration; if not already known, breakpoint cluster region- abelson murine leukemia viral oncogene homolog (BCR-ABL) status (p or p) must be evaluated in Ph-positive patients by PCR\r\n* For Cohort , Ph-like testing is not required specifically for this study; however, to be registered to Cohort under the Ph-like DSMKF criterion, the patient must have a known or presumed activating Ph-like signature and dasatinib-sensitive mutation or kinase fusion, such as: ABL, ABL, colony stimulating factor receptor (CSFR), platelet derived growth factor receptor beta (PDGFRB), platelet derived growth factor receptor alpha (PDGFRA), or fibroblast growth factor receptor (FGFR)s that was otherwise identified as part of normal standard of care; prior to registering any patients with a known or presumed activating Ph-like signature and dasatinib-sensitive mutations or kinase fusions (DSMKF) treating physicians must confirm eligibility with the study chairs via email; the study chairs must respond via email with confirmation of patient eligibility prior to patient registration
Cohort , Ph-positive and Ph-like DSMKF Patients Only
Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within days prior to registration to S; specimens must be submitted to the sites preferred CLIA-approved cytogenetics laboratory; BCR-ABL status must be verified in Ph-positive patients by FISH, cytogenetics, and/or PCR prior to enrollment; if a patient is Ph-positive, PCR for both p and p must be sent
Patients known to have Philadelphia chromosome positive (Ph+) ALL must have either failed treatment or been intolerant to treatment with at least one second or third generation tyrosine kinase inhibitor
Patients known to have Philadelphia (Ph) positive (+) ALL are not eligible; leukemia cell samples will be obtained from all patients enrolled before starting protocol treatment and submitted for Philadelphia chromosome testing by either karyotyping, or breakpoint cluster region (bcr)/Abelson murine leukemia viral oncogene homolog (abl) translocation by fluorescent in situ hybridization (FISH) or by PCR; patients who are later found to have Ph+ ALL should have treatment on this trial discontinued and will not be considered in the evaluation
Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL
Patients with Philadelphia chromosome (Ph)+ ALL or blast crisis of CML must be refractory (not intolerant) to at least second/third generation ABL kinase inhibitors (TKI)
Patients with Philadelphia chromosome (Ph)-positive ALL or Burkitt leukemia
Philadelphia chromosome (Ph)-positive ALL
Philadelphia chromosome positive (Ph+) patients must be refractory to or intolerant of standard tyrosine kinase inhibitor therapy
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy; maintenance therapy with Food and Drug Administration (FDA)-approved targeted therapies (e.g. tyrosine kinase inhibitors for Philadelphia chromosome [Ph] positive [+] acute lymphoblastic leukemia [ALL], and FLT inhibitors for FLT+ patients) will be allowed after day disease assessment
Philadelphia-positive (Ph+) ALL
World Health Organization (WHO)-defined acute lymphoblastic leukemia and either:\r\n* Relapsed after achieving remission\r\n* Refractory to therapy\r\n* Newly diagnosed and ineligible for intensive chemotherapy induction\r\nNote: patients with T lineage and B lineage ALL are eligible for this trial; likewise, patients with Philadelphia chromosome positive (Ph+) (as long as they are not candidate for other therapies for Ph+) and Ph- ALL are eligible
Philadelphia chromosome/BCR-ABL-positive B-lineage acute lymphoblastic leukemia (ALL) must have failed at least second or third generation tyrosine kinase inhibitor (TKI) or be intolerant to TKIs
Patients >= years of age with previously untreated Ph-positive ALL [either t(;) and/or BCR-ABL positive] (includes patients initiated on first course of hyper-CVAD before cytogenetics known).
PHASE I: Philadelphia chromosome positive ALL must have failed at least TKI
PHASE II: Philadelphia chromosome positive ALL must have failed at least TKI
Pediatric patients with acute lymphoblastic leukemia (ALL) that is t (,) positive in first remission are not eligible unless there is evidence of minimal residual disease after initial induction and/or consolidation treatment or the pediatric Philadelphia chromosome positive (Ph+) ALL is clinically refractory to available therapies with evidence of persistence in the bone marrow or peripheral blood.
Philadelphia chromosome (Ph)+ ALL
CELL PROCUREMENT: Subjects with Philadelphia chromosome (Ph)+ ALL will be eligible if they have failed >= ABL tyrosine kinase inhibitors; subjects with the TI ABL kinase point mutation will be eligible if they have failed ponatinib-containing therapy, regardless of the number of prior ABL tyrosine kinase inhibitors
Patients must have a diagnosis of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase by having met all of the following criteria at the time of their initial diagnosis\r\n* Cytogenetic confirmation of Philadelphia chromosome or variants of the t(;) translocations; patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome\r\n* Peripheral blood or bone marrow blast count < %\r\n* Peripheral blood basophil count < %\r\n* Platelet count >= , x ^/L\r\n* If the peripheral blood counts are unavailable from the time of their original diagnosis, but there is no evidence of accelerated or blast-phase disease from prior clinical or other medical records, then they will be allowed to participate
Philadelphia chromosome (Ph)-positive ALL
Diagnosis of Philadelphia chromosome positive (Ph+) (by cytogenetics or FISH) or BCR-ABL+ (by polymerase chain reaction [PCR]) CML in CP (cohort ), AP (cohort ) or BP (cohort )
Patients with a diagnosis of Philadelphia chromosome (Ph)+ ALL are not eligible
For patients with Philadelphia chromosome positive (Ph+) disease, have previously received treatment with >= Abelson (ABL) kinase inhibitor (e.g., imatinib, dasatinib, etc.) or are ineligible for such treatment
Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis is months); except for hydroxyurea, patients must have received no or minimal prior therapy, defined as < month ( days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)
Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy
Participants with ALL with Philadelphia chromosome or with an ABL class targetable fusion are eligible.
Confirmation of Philadelphia chromosome positivity by cytogenetics (karyotype/fluorescence in situ hybridization [FISH]) and/or molecular tests (BCR-ABL transcripts)
Ph-negative ALL
Patients with Philadelphia chromosome positive (Ph+) ALL can be enrolled in CR or CR and beyond; a tyrosine kinase inhibitor (TKI) will be added at the discretion of the treating physician; MRD for these patients will be defined by PCR of .% and above (International Scale).
Patients years or older with Philadelphia chromosome (Ph)-positive or BCR/ABL-positive CML (as determined by cytogenetics, FISH, or PCR).
Patients with previously untreated ALL of pre-B, Philadelphia chromosome (Ph-) negative ALL; minimal prior therapy (less than week of steroids, vincristine, and/or dose of anthracycline or alkylating agents) are allowed
Philadelphia chromosome negative myeloproliferative disease
Philadelphia chromosome positive (Ph+) B-cell ALL eligible for tyrosine kinase inhibitor therapy
Philadelphia chromosome-positive (Ph+) ALL
For patients with Philadelphia chromosome positive (Ph+) ALL, they must not have progressed within months of receiving imatinib or have a documented ABL kinase mutation known to confer resistance to imatinib (e.g., TI)
Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
All previous immunologic or molecularly targeted therapy must be completed at least weeks prior to study entry; any prior non-hematologic toxicity of any previous therapy must have resolved to grade or less, unless specified elsewhere, or except breakpoint cluster region/tyrosine-protein kinase ABL (BCR-ABL) tyrosine kinase in patients who have Philadelphia chromosome positive (Ph+) ALL, where there will be no washout period
Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR
Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR.
Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but with one log BCR-ABL reduction (BCR-ABL level >% IS) months of imatinib mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of weeks interruption of treatment with imatinib (cumulative) within the month period before randomization). Imatinib monotherapy must have been started within months of CP-CML diagnosis (Ph + /BCR-ABL detection)
AML participants who are Philadelphia chromosome positive must have received ? lines of therapy, including bcr-abl tyrosine-kinase (TK) inhibitors (among imatinib, nilotinib and dasatinib), or only line including TK inhibitor if the relapse/refractoriness is associated with the detection of a resistance mutation to these inhibitors
Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
Prior treatment with or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
Philadelphia chromosome (Ph)+ ALL
Ph+ CML; the diagnosis of chronic phase CML based on cytogenetic detection of the Ph chromosome and/or detection of the breakpoint cluster region (BCR)-Abelson (ABL) rearrangement by molecular analysis (recombinant deoxyribonucleic acid [DNA] analysis of the BCR-ABL fusion gene, fluorescence in situ hybridization, or polymerase chain reaction detection of the BCR-ABL hybrid messenger ribonucleic acid [mRNA])
Confirmed new diagnosis of Philadelphia chromosome-positive or BCR-ABL positive precursor B cell acute lymphoblastic leukemia (B-ALL) based on >= % lymphoblasts in bone marrow or blood; outside specimens will be subject to central review at the Huntsman Cancer Institute (HCI) Department of Pathology; BCR-ABL or Philadelphia-chromosome positivity may be determined by polymerase chain reaction (PCR), conventional cytogenetics and/or fluorescence in situ hybridization (FISH)
Presence of the Philadelphia chromosome t(;)
Relapsed or refractory B-ALL due to receive salvage , , , , , or ; half of the patients, i.e. out of the first patients, and out of patients thereafter, need to be in earlier line of salvage therapy, defined as st, nd, or rd line of salvage therapy; Philadelphia chromosome-positive (Ph+) B-ALL patients must have failed treatment with at least second generation tyrosine kinase inhibitor; patients in salvage with late relapse should be deemed poor candidates for reinduction with initial therapy; patients with ALL of T cell origin (T-ALL) can not be treated
Patients with Ph+ B-precursor ALL, with any of the following:
Chromosome q deletion
Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
Patients with Philadelphia chromosome (Ph) positive (+) pre-B cell ALL OR Ph+ MPAL will be eligible if they have been refractory to or intolerant of treatment with at least second-generation or third-generation tyrosine kinase inhibitor (TKI)