araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors

Summary: RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer.
  PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.
  Secondary
  -  To determine the safety of proactive enteral nutrition in these patients.
  -  To evaluate the effect of enteral nutrition on nutritional status in these patients.
  OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube. Tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4 of chemotherapy.

Eligibility: Inclusion Criteria:
  -  Newly confirmed diagnosis of 1 of the following:
  -  Acute myeloid leukemia
  -  Myelodysplastic syndromes
  -  Sarcoma
  -  Any other stage IV solid tumor including:
  -  Wilms
  -  Neuroblastoma
  -  Hepatoblastoma
  -  Any primary cancer of the central nervous system including:
  -  Cerebellar astrocytoma
  -  Medulloblastoma
  -  Ependymoma
  -  Spine tumors
  Exclusion Criteria:
  -  No contraindication to enteral tube feeding including, but not limited to, any of the following:
  -  Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)
  -  Active sinusitis (can be waived for patients with gastrostomy tubes)
  -  Obstructive tumor in the nasopharynx
  PRIOR CONCURRENT THERAPY:
  -  No prior hematopoietic stem cell transplant
  -  All clinically indicated medications are permitted during the course of the study
  -  No other concurrent nutritional supplements

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

Summary: This study will see if the researchers can lower that risk by giving the patient Palifermin. This drug helps protect the lining of the mouth, throat, and stomach. These areas typically get sores or ulcers while the blood cell counts are very low. The patient can get infections in or from these sores. Palifermin might also help the immune system recover faster. It is currently approved for patients who receive their own stem cells. That is called an autologous transplant. This study will test the use of Palifermin for T-cell depleted allogeneic stem cell transplants.


Eligibility: Inclusion Criteria:
  -  Patients should be < 65 years. Patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the BMT Service.
  -  Patients may be of either gender or any ethnic background.
  -  Patients must have a Karnofsky or Lansky Performance Status > or equal to 70%.
  -  Patients must have adequate organ function measured by:
  * Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > or equal to 50% and must improve with exercise.
  -  Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
  -  Renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 60-ml/min/1.73 m2
  -  Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)
  -  Each patient must be willing to participate as a research subject and must sign an informed consent form.
  -  Parent or legal guardians of patients who are minors will sign the informed consent form.
  Exclusion Criteria:
  -  Active CNS or skin leukemic involvement
  -  Female patients who are pregnant or breast-feeding
  -  Active viral, bacterial or fungal infection
  -  Patient seropositive for HIV-I/II; HTLV -I/II
  -  Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
  -  Patients who have had a previous malignancy that is not in remission.

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission

Summary: This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).

Detailed description: The primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with AML in first complete remission treated with autologous BMT.
  Secondary objectives used transduction of marker genes into autologous marrow to determine the following:
  1. whether the source of relapse after BMT for AML is residual malignant cells in the harvested marrow or in the patient, and whether marrow purging is therefore rational.
  2. whether the majority of AML, which lack genetic markers, represent abnormalities in a multi-lineage progenitor cell, and whether therefore, auto grafting/intensified chemotherapy is ever likely to augment the cure rate.
  3. the mechanisms of autologous reconstitution, and the effects of stimuli which modify the process.

Eligibility: Inclusion Criteria:
  -  Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol.
  -  Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.
  Exclusion Criteria:
  -  Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant.
  -  Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia)
  -  Life expectancy limited by disease other than leukemia
  -  Significant cardiac disease (echo shortening fraction <25% or MUGA scan <50%)
  -  Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min
  -  Severe restrictive pulmonary disease (FCV less than 40% of predicted)
  -  Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU)
  -  Severe personality disorder or mental illness
  -  Previous severe cystitis from cyclophosphamide
  -  Previous total dose of anthracyclines of >450 mg/m2
  -  Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation
  -  Previous autologous transplant
  -  HIV reactivity
  -  Karnofsky score <70%

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

Summary: This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.


Eligibility: Inclusion Criteria:
  -  Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments
  -  Normal organ function, and chest x-ray
  -  Expected survival greater than 8 weeks
  -  Can care for most of personal needs and perform at least minimum activity
  Exclusion Criteria:
  -  Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia
  -  Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants
  -  Patients with heart function that is not normal
  -  Patients with HIV or hepatitis
  -  Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.
  PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
  -  To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.
  OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.

Eligibility: -  Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665
  -  Short-term or long-term survivor
  -  Bone marrow and/or peripheral blood obtained at diagnosis
  -  Leukemia is one of the following cytogenetic subtypes:
  -  t(8;21)
  -  t(15;17)
  -  inv(16)

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial

Summary: RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and determine a patient's eligibility for a treatment clinical trial. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical trial.

Detailed description: OBJECTIVES:
  -  To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients with suspected leukemia or related hematologic disorders for enrollment on ECOG leukemia clinical trials.
  -  To obtain baseline samples for correlative studies outlined in parent clinical trials.
  OUTLINE: This is a cohort, multicenter study.
  Patients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials.

Eligibility: DISEASE CHARACTERISTICS:
  -  Candidate for enrollment on an ECOG treatment clinical trial for acute or chronic leukemia
  -  Suspected clinical diagnosis and protocol ID number of the treatment clinical trial under consideration must be submitted to ECOG's Leukemia Translational Studies Laboratory to ensure that the required antibody panels are used and functional assays are performed
  -  Chosen ECOG treatment clinical trial must be active and accruing
  -  Patient must not have begun treatment on the ECOG treatment clinical trial
  -  Patient may be concurrently enrolled on this laboratory study and a treatment clinical trial if immediate treatment is medically necessary
  -  If subsequent diagnostic review alters the original diagnosis, the patient will be removed from the treatment clinical trial
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia

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

Detailed description: OBJECTIVES:
  -  To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
  -  To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
  -  To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.
  OUTLINE: This is a multicenter study.
  Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.

Eligibility: DISEASE CHARACTERISTICS:
  -  Pretreatment RNA specimens* available from patients with acute myeloid leukemia (AML) registered for front-line therapy on the following clinical trials:
  -  SWOG-9031
  -  SWOG-9126
  -  SWOG-9333
  -  SWOG-9500
  -  Cryopreserved pretreatment cell specimens* available from a subset of patients (those who obtained a complete response [CR] and remained in CR without relapse for ≥ 2 years vs those with resistant disease [i.e., failed to achieve CR with evidence of persistent AML following induction therapy]) NOTE: All specimens currently available in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University of New Mexico
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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