araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Cord Blood Transplant for Hematologic Malignancy

Summary: Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery in patients receiving myeloablative conditioning as part of an umbilical cord blood transplant for hematologic cancer. In this study, the safety and tolerability of CLT-008 administered 24 hours after an umbilical cord blood transplant will be determined by monitoring for adverse reactions, neutrophil and platelet recovery, hematopoietic chimerism, graft-versus-host disease (GVHD), and infections.


Eligibility: Key Inclusion Criteria:
  -  Undergoing allogeneic (4-6/6 matched) umbilical cord blood graft with at least 2.5 x 10e7 cells/kg for hematological malignancy:
  -  High risk acute myeloid leukemia (AML) in complete remission
  -  Very high risk pediatric AML; patients <21 years eligible with <25% blasts in marrow after failed chemotherapy
  -  High risk acute lymphocytic leukemia (ALL) in complete remission
  -  Chronic myelogenous leukemia (CML), excluding refractory blast crisis
  -  Myelodysplasia (MDS) IPPS Int-2 or high risk, or refractory anemia with severe pancytopenia or high risk cytogenetics
  -  Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after two prior therapies
  -  Lymphoplasmacytic, lymphoma, mantle-cell lymphoma, prolymphocytic leukemia after initial therapy and complete or partial remission
  -  Large cell non-Hodgkin lymphoma (NHL) in second complete or partial remission (chemotherapy refractory large cell NHL not eligible)
  -  Lymphoblastic lymphoma, peripheral T cell lymphoma including angioimmunoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in complete or partial remission, or after progression if stage I/II <1 year (chemotherapy refractory high-grade NHL not eligible)
  -  Multiple myeloma beyond 2nd partial remission
  -  Preparative regimen consisting of cyclophosphamide, fludarabine, and total body irradiation
  -  Adequate organ function
  Key Exclusion Criteria:
  -  Symptomatic underlying pulmonary disease or requiring oxygen
  -  Active infection
  -  HIV positive
  -  Pregnant or nursing

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
  -  Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
  -  Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.
  OUTLINE: This is a multicenter, pilot study.
  Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
  PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Normal karyotype
  -  Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required
  -  No additional samples required

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia

Summary: This research trial studies multidrug resistance genes in patients with acute myeloid leukemia. Studying samples of bone marrow or blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To investigate the association of common single nucleotide polymorphisms (SNPs) and haplotypes of the three multidrug resistance (MDR) genes with treatment outcome in the clinical studies.
  II. To assess the effect of ATP-binding cassette (ABC) B1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in younger patients enrolled on Cancer and Leukemia Group B (CALGB) 9621 and 19808.
  III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on treatment outcome in older patients enrolled on CALGB 9720.
  SECONDARY OBJECTIVES:
  I. To test the hypothesis that ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes are associated with phosphoglycolate phosphatase (Pgp), multidrug resistance protein 1 (MRP-1), and ATP-binding cassette, sub-family G (WHITE), member 2 (Junior blood group) (BCRP) function and expression in pre-treatment blasts from acute myeloid leukemia (AML) patients.
  II. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP, MRP-1, and BCRP function through CALGB 9760 in younger patients enrolled on CALGB 9621 and 19808.
  III. To assess the effect of ABCB1, ABCC1, and ABCG2 polymorphisms and haplotypes on PGP, MRP-1, and BCRP function through CALGB 9760 in older patients from CALGB 9720.
  IV. To conduct an exploratory analysis of the association of additional candidate genes relevant to etoposide, cytarabine, and daunorubicin with chemotherapy response and toxicity.
  OUTLINE:
  Leukemia blast cells obtained from bone marrow aspirate or peripheral blood at diagnosis are used to study polymorphisms and haplotypes of ATP-binding cassette (ABC) B1, ABCC1, ABCG2, and other candidate genes. Multidrug resistance (MDR) protein expression and function are also analyzed using leukemia blast cells from patients enrolled on CALGB-9760.
  PROJECTED ACCRUAL: Tissue samples from over 600 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Treated on protocols CALGB-9621, CALGB-9720, or CALGB-19808
  -  Registered on the mandatory companion Leukemia Tissue Bank Protocol CALGB-9665
  -  Registration on another companion trial, CALGB-9760, (Multidrug Resistance Studies in Acute Leukemia) allowed
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Summary: RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:
  -  Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of acute lymphoblastic leukemia or acute myeloid leukemia (AML) in infants and monoblastic variants of AML in young patients.
  -  Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of secondary AML in young patients.
  -  Compare secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites.
  OUTLINE: This is a multicenter study.
  Bone marrow or blood are collected and analyzed by Southern blot for chromosome 11q23 breakpoints and translocations. Samples from patients with secondary acute myeloid leukemia are also examined for MLL gene rearrangements.
  PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of leukemia meeting 1 of the following criteria:
  -  Acute lymphoblastic leukemia OR acute myeloid leukemia (AML) (< 1 year of age at diagnosis)
  -  M4 OR M5 AML (< 5 years of age at diagnosis)
  -  Secondary leukemia (< 21 years of age at diagnosis)
  -  Bone marrow sample, peripheral blood (WBC > 10,000/mm³ and 20% peripheral blasts), or pheresis bag available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients

Summary: The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.

Detailed description: At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Acute myeloid leukemia in remission.
  -  Able to take aspirin 81mgs daily.
  Exclusion Criteria:
  -  Pregnant or breast feeding females.
  -  Known hypersensitivity to thalidomide.
  -  Any prior use of lenalidomide.

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

Summary: The present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.


Eligibility: Inclusion Criteria:
  -  adult men and women with newly diagnosed acute myeloid leukemia
  Exclusion Criteria:
  -  under age 18 years

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Collect DNA samples from patients with cytogenetically, well characterized, and uniformly treated acute lymphoblastic leukemia or acute myeloid leukemia for use in analysis of a wide range of host factors influencing etiology and outcome of the disease.
  -  Identify host factors that can be determined at onset of treatment to predict outcome of chemotherapy, and thus modify the therapy administered.
  OUTLINE: Previously collected DNA samples are analyzed for polymorphisms at a variety of loci. Gene expression and expression profiles are correlated with genotype and therapy outcomes.

Eligibility: DISEASE CHARACTERISTICS:
  -  DNA samples available from patients meeting the following criteria:
  -  Infants with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
  -  Patients with pre-B ALL, including responders vs non-responders in selected genotypes [hyperdiploid, hypodiploid, t(12;21), t(9;22), t(1;19), and t(4;11)] and responders and non-responders regardless of genotype
  -  Pediatric patients with AML registered on POG-9421
  -  Adult patients with ALL, including t(8.21), inv(16), t(15;17), complex cytogenetics, and secondary AML
  -  Pediatric patients with relapsed ALL enrolled on COG-AALL01P2
  -  Pediatric patients enrolled on COG-9900 and other CCG or POG trials
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)

Summary: In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

Detailed description: In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In current formulations, the volume of plerixafor required to administer doses higher than 240 mcg/kg may result in significant discomfort with repeated daily injections. In this phase I extension study, we seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

Eligibility: Inclusion Criteria:
  -  Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:
  -  Primary refractory disease following ≥ 1 round of induction chemotherapy
  -  First relapse or higher
  -  Age between 18 and 70 years
  -  ECOG performance status ≤ 2
  -  Adequate organ function defined as:
  -  Creatinine ≤ 1.5 x institutional ULN
  -  AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  -  ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  -  Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  -  Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
  -  Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
  -  Able to provide signed informed consent prior to registration on study
  Exclusion Criteria:
  -  Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
  -  Peripheral blood blast count ≥ 50 x 103 /mm3
  -  Active CNS involvement with leukemia
  -  Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
  -  Pregnant or nursing
  -  Concurrently receiving any other investigational agent
  -  Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
  -  Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
  -  Severe concurrent illness that would limit compliance with study requirements

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.

Detailed description: OBJECTIVES:
  -  To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
  -  To classify AML-based signal transduction mechanisms.
  -  To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.
  OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:
  -  Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
  -  Relapsed disease (early or late)
  -  In continuous complete remission
  -  Previously enrolled on POG-9421
  -  Tissue samples available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia

Summary: Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in overall AML, expected to harbor a favorable prognosis. However, around a half of cases relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome. The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital, Korea between 1994 and 2008.
  1. Construction of the CBF positive AML patient cohort: clinical database establishment (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
  2. Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
  3. Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
  4. Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.
  The current study attempts to analyze genetic data of core binding factor (CBF) positive acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis.
  1. To detect microcytogenetic lesions and will analyze its prognostic significance
  2. To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
  3. To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The present study will establish individualized therapy for CBF positive AML, will provide a basis for molecular marker guided clinical trial in CBF positive AML.


Eligibility: Inclusion Criteria:
  -  patients with core binding factor positive acute myeloid leukemia
  -  18 years or older
  -  patients were treated with standard chemotherapy
  -  patients with available medical record and stored bone marrow specimen at time of diagnosis
  Exclusion Criteria:
  -  no definive criteria

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

Summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.


Eligibility: Inclusion Criteria:
  -  Diagnosis of one of the following
  -  Newly diagnosed de novo acute myeloid leukemia (AML)
  -  AML secondary to myelodysplastic syndromes (MDS)
  -  AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years
  -  Bone marrow blasts >30%
  -  Age ≥ 65 years
  -  Easter Cooperative Oncology Group (ECOG) 0-2
  Exclusion Criteria:
  -  Previous cytotoxic or biologic treatment for AML (except hydroxyurea)
  -  Previous treatment with azacitidine, decitabine or cytarabine
  -  Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors)
  -  AML French American British subtype (FAB M3)
  -  AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes
  -  Prior bone marrow or stem cell transplantation
  -  Candidate for allogeneic bone marrow or stem cell transplant
  -  Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure)
  -  Malignant hepatic tumors
  -  Uncontrolled systemic infection
  -  Active viral infection with Human Immunodeficiency Virus (HIV) or Hepatitis type B or C
  -  Use of any experimental drug or therapy within 28 days prior to Day 1

Relevance to patient case: not relevant