araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: New Therapy for Advanced Stage Leukemia After Stem Cell Transplantation

Summary: Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia, particularly for patients with advanced-stage leukemia. However, relapse rate was still very high for advanced-stage leukemia.
  It was found in our previous study that infusion of granulocyte colony-stimulating factor (G-CSF)-primed peripheral blood progenitor cells (GPBPC) instead of non-primed lymphocytes exhibited a comparative or stronger graft-versus-leukemia (GVL) effect and comparative or less incidence of GVHD, rarely being complicated with pancytopenia. When GPBPC infusion was combined with the use of short-term immunosuppressant for GVHD prophylaxis, the incidence of fatal GVHD complicated with GPBPCI was further reduced. Our primary data showed the GPBPCI combined with the use of short-term immunosuppressant was feasible in patients with advanced leukemia to prevent relapse after HLA-mismatched HSCT.
  The study hypothesis:
  Prevention of relapse using granulocyte colony-stimulating factor-primed peripheral blood progenitor cells following hematopoietic stem cell transplantation in patients with advanced-stage acute leukemia can
  -  reduce relapse rate
  -  improve survival

Detailed description: A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed in patients for which no GVHD occurred or free of GVHD after 2 weeks off immunosuppression for patients receiving GPBPCI after day 90 post HSCT. Before administration of GPBPCI, serious infection had to be cleared and no serious organ failure could be present. The GPBPCI regimen was comprised of G-CSF-primed PBSCs instead of harvested non-primed donor lymphocytes and short-term immunosuppressive agents for prevention of GVHD after GPBPCI. Chimerism status was examined before and after prophylactic treatment with GPBPCI.

Eligibility: Inclusion Criteria:
  -  high-risk leukemia after HSCT
  Exclusion Criteria:
  -  active GVHD
  -  early relapse

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

Summary: The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.


Eligibility: Inclusion Criteria:
  -  Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
  -  20 years old over
  -  ECOG performance status (PS) score 0-2
  -  Adequate organ function (hepatic, renal and lung)
  -  Signed written informed consent
  Exclusion Criteria:
  -  A case with the double cancer of the activity
  -  Women who are pregnant or breastfeeding
  -  The case of Pleural effusion clearly
  -  Patients with complications or a history of severe or uncontrolled cardiovascular failure following
  -  have a Myocardial infarction whithin 6 months
  -  have an Angina within 3 months
  -  have a Congestive heart failure within 3 months
  -  have a QTc interval of more than 450msec at baseline
  -  A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Relevance to patient case: definitely relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Comparison of Laboratory Test Results of Minimal-Residual Disease in Samples From Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia.
  PURPOSE: This research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To promote harmonization between Cooperative Group Reference Laboratories conducting minimal-residual disease (MRD) evaluation of acute myeloid leukemia by flow cytometry.
  OUTLINE: Archived bone marrow and blood samples, distributed to the Eastern Cooperative Oncology Group, Southwest Oncology Group, and Cancer and Leukemia Group B laboratories, are analyzed for leukemia-associated immunophenotype (LAIP) assays and minimal residual disease studies by flow cytometry. Results are then provided to the National Cancer Institute for assessment and comparability of test results.

Eligibility: DISEASE CHARACTERISTICS:
  -  Non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (AML) from the Children Oncology Group (COG) studies
  -  Baseline/diagnostic AML samples
  -  Samples collected after initial treatment and representing varying levels of residual blast counts
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia

Summary: CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.

Detailed description: Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.

Eligibility: Inclusion Criteria:
  -  Relapsed or refractory acute lymphoblastic leukemia,
  -  Burkitts leukemia/lymphoma,
  -  Lymphoid blastic CML,
  -  Lymphoblastic lymphoma.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients

Summary: The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
  -  Stage III with elevated LDH level ("B-high"), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL.
  -  6 months to less than 18 years of age at the time of consent.
  -  Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
  -  Complete initial work-up within 8 days prior to treatment that allows definite staging.
  -  Able to comply with scheduled follow-up and with management of toxicity.
  -  Signed informed consent from patients and/or their parents or legal guardians
  Exclusion Criteria:
  -  Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
  -  Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
  -  Evidence of pregnancy or lactation period.
  -  There will be no exclusion criteria based on organ function.
  -  Past or current anti-cancer treatment except corticosteroids during less than one week.
  -  Tumor cell negative for CD20
  -  Prior exposure to rituximab.
  -  Severe active viral infection, especially hepatitis B.
  -  Hepatitis B carrier status history of HBV or positive serology.
  -  Participation in another investigational drug clinical trial.
  -  Patients who, for any reason, are not able to comply with the national legislation.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia

Summary: This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia

Detailed description: STUDY SUBTYPE: Ancillary/Correlative
  OBSERVATIONAL STUDY MODEL: Case-only
  TIME PERSPECTIVE: Retrospective
  BIOSPECIMEN RETENTION: Samples with DNA
  BIOSPECIMEN DESCRIPTION: Fresh and frozen bone marrow cells
  STUDY POPULATION DESCRIPTION: Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank
  SAMPLING METHOD: Non-probability sample
  OBJECTIVES:
  I. To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur.
  II. To identify replication-timing changes as a biomarker for further risk prediction.
  III. To identify differences between patients of similar subtype, and choose candidate differences to analyze by methods that are compatible with frozen samples.
  OUTLINE:
  Archived cell samples are analyzed for replication timing by flow cytometry, microarray, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed.

Eligibility: Inclusion Criteria:
  -  Frozen viable cell samples from patients with B-cell acute lymphoblastic (ALL) of any outcome from the Children's Oncology Group (COG) ALL Cell Bank (Part 1)
  -  Freshand frozen cell samples from patients with B-cell ALL with known outcomes from the COG ALL Cell Bank (Part 2) meeting 1 of the following criteria:
  -  Samples from patients who experienced an early recurrence within 36 months of diagnosis (cases)
  -  Samples from patients who remain in prolonged remission (controls)
  -  No samples meeting either of the following criteria:
  -  Very-high-risk features
  -  Philadelphia chromosome positive
  -  Hypodiploid
  -  MLL (11q23) rearranged
  -  Known favorable risk factors
  -  Hyperdiploid
  -  t(12;21) (ETV6/RUNX1)

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Compassionate Use Ponatinib

Summary: The main purpose of this protocol is to provide expanded access to the study drug (Ponatinib/AP24534) for people with imatinib-, dasatinib-, and nilotinib- resistant/intolerant Philadelphia Chromosome Positive (Ph+) Leukemias. The other purpose of this protocol is to monitor the safety of the study drug in people with Ph+ Leukemias that have not responded to prior treatment.


Eligibility: Inclusion Criteria:
  -  Signed and dated informed consent
  -  Cytogenetic or PCR-based diagnosis of any phase of Ph+ acute lymphoblastic leukemia (ALL) and documented resistance or intolerance to imatinib and a second TKI (nilotinib, dasatinib, bosutinib)
  -  Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
  -  Washout from prior anti-proliferative or anti-leukemia treatment: 3 days for hydroxyurea/anagrelide and tyrosine kinase inhibitors
  -  < Grade 2 or baseline recovery from prior therapy related toxicities (except alopecia)
  -  At least 3 months post allogeneic stem cell transplantation
  -  Able to take oral capsules reliably
  -  AST/ALT less than or equal to 2.5 times ULN, or less than 5 times ULN if attributable to involvement of leukemia
  -  No active clinical or radiographic pancreatitis
  -  At least 18 years of age
  -  Willingness of male and female subjects to use reliable methods of birth control (when applicable)
  Exclusion Criteria:
  -  Subjects with Philadelphia Chromosome and BCR-ABL-negative chronic myeloid leukemia (CML)
  -  Major surgery or radiotherapy within 7 days before the first dose of Ponatinib (recovery from any previous surgery should be complete before day 1)
  -  Clinically significant active/uncompensated or uncontrolled cardiac disease (active congestive heart failure; uncontrolled angina or hypertension; myocardial infarction in the past 3 months; clinically significant untreated ventricular arrhythmia; diagnosed or suspected congenital or acquired prolonged QT syndrome; unexplained syncope; history of prolonged QTc)
  -  Prolonged QTc (> 0.48 sec)
  -  Pregnant or breastfeeding women
  -  Evidence of serious active infection, or significant medical or psychiatric illness
  -  Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, or clinically significant abnormal lab finding that would, in the investigator's judgment, make the subject inappropriate for this study
  -  Prior resistance to Ponatinib

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant

Summary: This pilot clinical trial studies mechanical stimulation in preventing bone density loss in patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or reverse bone loss, increase muscle and cardiac performance, and improve overall health

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.
  SECONDARY OBJECTIVES:
  I. To evaluate the data collection tools to prepare for a larger phase II trial.
  OUTLINE:
  Patients undergo mechanical stimulation over 20 minutes once daily (QD) beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).

Eligibility: Inclusion Criteria:
  -  Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
  -  Pre-transplant Karnofsky Performance Status (KPS) >= 70
  -  Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  Exclusion Criteria:
  -  Any prior allogeneic HCT
  -  Pre-transplant weight >= 280 lbs
  -  Body mass index (BMI) < l8kg/m^2
  -  Human leukocyte antigen (HLA)-mismatched HCT
  -  Cord blood transplant
  -  Osteopenia or osteoporosis (T-score =< -1.0)
  -  Multiple myeloma diagnosis
  -  Any prior history of a central nervous system (CNS) hemorrhage
  -  Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
  -  Current or previous bisphosphonate use
  -  Prior history of non-traumatic fracture
  -  Any screws, pins, rods, or other metal objects in the body
  -  Total joint replacement
  -  History of kidney stones or gall stones
  -  Any artificial limbs
  -  Pregnant or nursing female patients
  -  Unwilling or unable to follow protocol requirements
  -  Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

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

Detailed description: OBJECTIVES:
  -  Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
  -  Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
  -  Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.
  OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy
  -  Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age > 60 years)
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Studying Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

Summary: RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors identify learn more about biomarkers related to cancer. It may also help doctors to find better ways to treat cancer.
  PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia (T-ALL).

Detailed description: OBJECTIVES:
  -  Determine the metabolic status and regulation of primary T-cell acute lymphoblastic leukemia (T-ALL) relative to control resting peripheral T cells.
  -  Establish the effects of metabolic inhibition on metabolic stress pathways and apoptosis.
  -  Determine how metabolic inhibition interacts with chemotherapy or targeted therapy drugs to kill T-ALL cells.
  OUTLINE: T-ALL samples cultured alone or with gamma secretase inhibitors (GSI) or PI3K inhibitors are analyzed for metabolic characteristics including glucose transporter 1 (Glut1) expression, mitochondrial mass, phospho-flow for 5' adenosine monophosphate-activated protein kinase (AMPK), acetyl-CoA carboxylase (ACC), and mammalian target of rapamycin (mTOR) by flow cytometry. T-ALL samples and normal CD4+ T cells (control) are also exposed to ± 2-deoxyglucose or ± the glutaminolysis inhibitor media and analyzed for metabolic stress responses over time in particular, AMPK activation, autophagy (immunofluorescence for LC3-II processing), and BCL2-associated X protein (Bak) and Bax activation to indicate apoptosis. These cells (T-ALL and control) are then cultured with cyclophosphamide, dexamethasone, or the B-cell CLL/lymphoma 2 (Bcl-2) inhibitor, ABT-737, to determine cell death over time.

Eligibility: DISEASE CHARACTERISTICS:
  -  Sample from patients diagnosed with T-ALL
  -  Samples from independent healthy donors obtained through the Gulf Coast Regional Blood Center (controls)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Symptom Clusters in Children With Leukemia

Summary: The purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.

Detailed description: A repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

Eligibility: Inclusion Criteria:
  -  Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.
  Exclusion Criteria:
  -  Children without a definite diagnosis of leukemia will be excluded.
  -  Children must be able to understand and answer the questions on the questionnaires.
  -  Children with have a cognitive impairment (e.g. Down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Pathogenesis of Hematologic Malignancies

Summary: The cause of blood and bone marrow cancers is poorly understood; however, most research focuses on how cancer cells grow and develop. Because the causes of these cancers are unknown, current treatments may be unnecessarily harsh and often do not provide a cure. Identifying the causes of blood cancers would allow for the development of treatments that are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we will look for specific cancer cell abnormalities that are responsible for cancer cell growth. We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.


Eligibility: Inclusion Criteria:
  -  Suspected or confirmed diagnosis of AL, LPD, MDS, or MPD
  -  Male or female of all ages
  -  Willing and able to sign informed consent
  -  Willing guardian consent for participants under 18 years of age
  Exclusion Criteria:
  -  No suspected or confirmed diagnosis of acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), or myeloproliferative diseases (MPD)

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: A Safety Study of SGN-CD19A for Leukemia and Lymphoma

Summary: This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).


Eligibility: Inclusion Criteria:
  -  Adult patients must be relapsed or refractory to at least 1 prior multi-agent systemic therapy. Pediatric patients must be relapsed or refractory to at least 2 prior multi-agent systemic therapies. Patients with acute lymphoblastic leukemia who are Philadelphia chromosome-positive must have failed a second generation tyrosine kinase inhibitor.
  -  Eastern Cooperative Oncology Group status of 2 or lower
  -  Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
  -  Measurable disease
  Exclusion Criteria:
  -  Allogeneic stem cell transplant within 60 days, active acute or chronic graft-versus-host disease (GvHD), or receiving immunosuppressive therapy as treatment for GvHD

Relevance to patient case: not relevant