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

Clinical trial: Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With and Without Hematologic Cancer

Summary: RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors find better ways to treat the cancer.
  PURPOSE: This research study is looking at natural killer cells in bone marrow and blood samples from patients with hematologic cancer and from patients who do not have cancer.

Detailed description: OBJECTIVES:
  -  To collect normal and malignant cells in bone marrow and peripheral blood samples from patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma and from patients with no malignancy to use as target cells in cytotoxicity assays.
  -  To collect information about HLA type and immunophenotype of malignant cells as determined by clinical flow cytometry.
  OUTLINE: Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.
  Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  No evidence of malignancy
  -  Diagnosis of one of the following:
  -  Acute myeloid leukemia
  -  Acute lymphoblastic leukemia
  -  Chronic myelogenous leukemia
  -  Multiple myeloma
  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: S9910, Collecting and Storing Blood and Bone Marrow Samples From Patients With Hematologic Cancer

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 how well patients will respond to treatment.
  PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with hematologic cancer to be tested in the laboratory.

Detailed description: Primary objective:
  -  Maintain and expand tissue repositories of highly characterized samples from patients with acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes.
  Other objectives as funding permits:
  -  Develop laboratory assays for rapid and precise diagnosis of leukemia using bone marrow and peripheral blood samples.
  -  Determine biologic, genetic, and molecular parameters that distinguish different subtypes of human leukemia with differing responses to therapy, and develop "risk-adapted" therapeutic approaches based on these parameters to tailor therapeutic regimens, randomize or stratify patients in clinical trials, or otherwise assist in therapeutic decision-making.
  -  Develop new automated and standardized laboratory methods for the detection and monitoring of therapeutic responsiveness and minimal residual disease in patients and use this information to design clinical trials.
  OUTLINE: Patients receive treatment as directed by the Southwest Oncology Group (SWOG) study to which they are registered.
  Patients undergo collection of peripheral blood (myeloid leukemia) or venous blood (lymphoid leukemia) and bone marrow at baseline, at the time of response or remission, and at the time of progression or relapse. Additional collections may take place according to the guidelines of the study in which the patient is registered.
  Specimens are stored for use in laboratory research.
  PROJECTED ACCRUAL: Samples from a maximum of 1,000 patients will be collected for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Currently registered on a Southwest Oncology Group (SWOG) treatment study for acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes
  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: 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: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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

Clinical trial: S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers

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. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.

Detailed description: Primary objective:
  * Maintain and expand a database of cytogenetic information on leukemia patients.
  Other objectives as funding permits:
  -  Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.
  -  Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.
  -  Provide quality control for all Southwest Oncology Group cytogenetic data.
  OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.
  PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia [AML], 500 with first-line acute lymphoblastic leukemia [ALL], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia [CML], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Registered on one of the following Southwest Oncology Group treatment protocols:
  -  SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990
  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: 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: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

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

Clinical trial: Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia

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 gene expression in tissue samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development.
  OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities
  -  No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities
  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: Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia

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. It may also help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is looking at biomarkers in cell samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To characterize Stat3 signaling pathway activity in primary tissue samples from pediatric patients with acute myeloid leukemia to determine the percentage of samples with increased activity and to better understand the mechanisms leading to increased activity.
  -  To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low and high doses of cytokines.
  -  To evaluate the expression levels of Stat3 protein as well as upstream and downstream regulators of Stat3 activation.
  -  To classify tissue samples according to a Stat3-activation pattern, and to correlate this result with event-free survival and overall survival in order to determine whether increased Stat3 phosphorylation at diagnosis predicts poor outcome.
  OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including immunoblotting, fluorescence activated cell sorting (FACS), and protein analysis.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of pediatric acute myeloid leukemia
  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: Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia

Summary: This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
  II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.
  III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
  IV. To identify genomic alterations contributing to induction failure in childhood AML.
  OUTLINE:
  Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.

Eligibility: Inclusion Criteria:
  -  Diagnosis of acute myeloid leukemia
  -  High-risk disease
  -  Treated on COG-AAML03P1 or COG-AAML0531
  -  Meets the following criteria:
  -  Initial remission with no known adverse risk factors
  -  High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
  -  Highly enriched specimens with >= 50% blast available

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

Clinical trial: Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant

Summary: RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen samples form cancer survivors who underwent donor stem cell transplant.

Detailed description: OBJECTIVES:
  -  To examine semen samples from male survivors of allogeneic hematopoietic stem cell transplantation for the presence of donor-derived DNA.
  OUTLINE: Semen samples are collected and assessed by flow cytometry and PCR. DNA samples are compared to previously analyzed DNA extracted from survivor and donor. Samples are also analyzed for sperm concentration, motility, morphology, and viability.

Eligibility: DISEASE CHARACTERISTICS:
  -  Disease in remission
  -  More than 365 days since prior allogeneic hematopoietic stem cell transplantation with history of full donor engraftment
  -  Stable complete donor chimerism
  PATIENT CHARACTERISTICS:
  -  Able to consent and willing to provide a semen sample
  -  Survivors who present for long-term follow-up appointments in the adult and pediatric stem cell transplant clinic at Vanderbilt University Medical Center
  -  No known history of infertility or azospermia
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No history of testicular irradiation ≥ 200 cGy

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

Clinical trial: Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
  -  Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.
  OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  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: Biomarkers in Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of 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 research study is studying biomarkers in patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia.
  OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Available blood samples from diagnosis, remission, and relapse
  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: Biomarkers in Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
  -  Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.
  OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  One of the following karyotypes:
  -  t(8;21) and WT c-kit
  -  t(8;21) and mutant c-kit
  -  Normal karyotype
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant