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

Clinical trial: Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

Detailed description: OBJECTIVES:
  -  Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine.
  -  Assess the toxicity of this regimen in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).
  Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia
  -  M3 marrow (at least 25% blasts in bone marrow aspirate)
  -  Refractory to conventional therapy
  PATIENT CHARACTERISTICS:
  Age:
  -  21 and under at diagnosis
  Performance status:
  -  ECOG 0-2 OR
  -  Zubrod 0-2
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin normal
  -  SGOT or SGPT no greater than 2.5 times upper limit of normal
  Renal:
  -  Creatinine normal OR
  -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent immunomodulating agents
  Chemotherapy:
  -  At least 2 weeks since prior chemotherapy
  -  No other concurrent chemotherapy for cancer
  Endocrine therapy:
  -  No concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response
  -  Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions
  Radiotherapy:
  -  Concurrent radiotherapy to localized painful lesions allowed
  Surgery:
  -  Not specified
  Other:
  -  Recovered from any prior therapy

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

Clinical trial: Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia

Summary: RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
  PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.

Detailed description: OBJECTIVES:
  -  Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation.
  -  Determine the toxicity of this regimen in these patients.
  -  Determine survival in these patients treated with this regimen.
  -  Determine the incidence of graft-versus-host disease in these patients treated with this regimen.
  OUTLINE: Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0.
  Patients are followed every 1-2 weeks for 6 months.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder
  -  Eligible for allogeneic bone marrow transplantation, but lacking a donor
  -  Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci
  -  HIV negative
  -  Hepatitis B surface antigen and hepatitis C negative
  PATIENT CHARACTERISTICS:
  Age:
  -  Under physiologic 60
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin less than 2 times normal
  -  No severe hepatic disease
  -  Hepatitis B surface antigen and hepatitis C negative
  Renal:
  -  Creatinine less than 2 times normal
  Other:
  -  HIV negative
  -  Not pregnant or nursing
  -  No other serious medical or psychiatric illness that would preclude study compliance
  -  No serious infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

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

Clinical trial: Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Summary: RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
  PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.

Detailed description: OBJECTIVES:
  -  Determine the efficacy and safety of allogeneic peripheral blood stem cell transplantation in achieving engraftment in patients with hematologic malignancy.
  -  Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity, relapse, graft-versus-host disease, and survival of patients treated with this regimen.
  OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
  Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.
  PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following:
  -  Chronic myelogenous leukemia
  -  Philadelphia chromosome-positive OR
  -  Molecular evidence of bcr/abl gene rearrangement
  -  Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia
  -  Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
  -  Multiple myeloma
  -  Hereditary immunodeficiency disorders
  -  Confirmed by immunologic determination
  -  Sickle cell anemia or beta-thalassemia
  -  Confirmed by hemoglobin electrophoresis
  -  Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy)
  -  Confirmed by metabolic testing
  -  Other non-malignant conditions
  -  Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation
  PATIENT CHARACTERISTICS:
  Age:
  -  65 and under
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

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

Clinical trial: Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Summary: This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells

Detailed description: OBJECTIVES:
  I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
  II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.
  OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).
  Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed chronic myelogenous leukemia
  -  Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
  -  Accelerated or non-lymphoid blastic phase
  -  Performance status - ECOG 0-2
  -  Bilirubin no greater than 2 times upper limit of normal (ULN)
  -  AST no greater than 2 times ULN
  -  Creatinine less than 2.0 mg/dL
  -  Normal cardiac function
  -  No New York Heart Association class III or IV heart disease
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No prior decitabine
  -  At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
  -  Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
  -  Prior imatinib mesylate allowed
  -  Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
  -  No concurrent grapefruit or grapefruit juice

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

Clinical trial: Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

Summary: RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome.
  PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of cholecalciferol, in terms of hematological improvement, in patients with low- or intermediate-risk myelodysplastic syndromes.
  -  Determine the effect of this drug on disease symptoms, fatigue, and the overall health-related quality of life of these patients.
  OUTLINE: This is an open-label, pilot study.
  Patients receive oral cholecalciferol once daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed myelodysplastic syndromes (MDS)
  -  Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months
  -  International Prognostic Scoring System score of 0 or 1
  PATIENT CHARACTERISTICS:
  Age
  -  Any age
  Performance status
  -  Any
  Life expectancy
  -  More than 1 year
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  No history of hypercalcemia
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Prior stem cell transplantation allowed
  -  No concurrent hematopoietic growth factors
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  More than 6 weeks since prior cholecalciferol supplements or analogs
  -  More than 4 weeks since any prior therapy for MDS (except supportive care)
  -  No other concurrent therapy for MDS

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

Clinical trial: HuMax-CD20 in Chronic Lymphocytic Leukemia

Summary: The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.


Eligibility: Inclusion Criteria:
  -  Chronic Lymphocytic Leukemia
  -  Circulating lymphocytes above a specific level
  -  Circulating lymphocytes showing certain markers
  Exclusion Criteria:
  -  Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
  -  Previous stem cell transplantation.
  -  Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.
  -  HIV positivity.
  -  Hepatitis B or hepatitis C.
  -  Other cancerous diseases, except certain skin cancers and cervix cancer.
  -  Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
  -  Participation in another trial with a different new drug 4 weeks prior to enrollment in study.
  -  Current participation in any other clinical study.
  -  Pregnant or breast-feeding women.
  -  Women of childbearing age who are unable or unwilling to use adequate contraception.

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

Clinical trial: A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Blood Related Cancers

Summary: The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions:
  Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1)
  Group A - Imatinib failure only (arms 2, 3 and 4)
  -  imatinib-resistant or intolerant CML - Chronic Phase (CP)
  -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)
  -  imatinib-resistant or intolerant CML - Blast Crisis (BC)
  Group B - Imatinib and other TKI failure (arms 2, 3 and 4)
  -  imatinib-resistant or intolerant CML - Chronic Phase (CP)
  -  imatinib-resistant or intolerant CML - Accelerated Phase (AP)
  -  imatinib-resistant or intolerant CML - Blast Crisis (BC)
  Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5)
  Systemic mastocytosis (Sm) (arm 6)


Eligibility: Inclusion Criteria:
  Main inclusion criteria include:
  -  Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: *developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- *have developed an intolerance to imatinib
  -  Relapsed or refractory Ph+ ALL
  -  Hypereosinophilic syndrome/chronic eosinophilic leukemia.
  -  Systemic mastocytosis who have a clinical indication for treatment.
  -  Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required
  -  CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible
  -  Written informed consent prior to any study procedures being performed
  Exclusion Criteria:
  -  Impaired cardiac function
  -  Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)
  -  Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs )
  -  Women who are pregnant or breastfeeding
  -  Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
  -  Patients unwilling to comply with the protocol.
  -  Known diagnosis of human immunodeficiency virus (HIV) infection
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: MK0457 in Patients With Leukemia (0457-003)

Summary: In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.


Eligibility: Inclusion Criteria:
  Part 1:
  -  Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis
  Part 2:
  -  Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
  -  At least 2 weeks since the last cytotoxic therapy
  -  Acceptable renal and hepatic function
  -  Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
  -  More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation
  Exclusion Criteria:
  -  Not fully recovered from previous anti-leukemia therapy
  -  Previous allogeneic bone marrow transplant
  -  Uncontrolled congestive heart failure
  -  Myocardial infarction within the last 3 months
  -  Active or uncontrolled infection
  -  Pregnancy or lactation
  -  Currently active second malignancy, other than non-melanoma skin cancer
  -  History of hepatitis B or C, known HIV positivity, or AIDS related illness

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

Clinical trial: Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

Summary: The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Detailed description: Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

Eligibility: Inclusion Criteria:
  -  Previously untreated BCR-ABL-positive ALL
  -  Age between 15 and 64 years
  -  Performance status between 0 and 3 (ECOG criteria)
  -  Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)
  -  Written informed consent to participate in the trial
  Exclusion Criteria:
  -  Uncontrolled active infection
  -  Another severe and/or life-threatening disease
  -  Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
  -  Another primary malignancy which is clinically active and/or requires medical interventions
  -  Pregnant and/or lactating women
  -  Past history of renal failure

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

Clinical trial: High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)

Summary: The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.

Detailed description: Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging due to a high incidence of relapse. Optimal post-remission therapy, therefore, has been a matter of vital concern. In some pediatric ALL studies, the use of high-dose methotrexate (MTX) as a consolidation therapy, has been shown to improve outcome, however, there has been no randomized controlled trials to test its clinical efficacy in adult ALL. With this concern, the Japan Adult Leukemia Study Group (JALSG) has planned a prospective randomized controlled trial comparing high-dose MTX and intermediate-dose MTX for ALL patients who are negative for BCR-ABL. Those who are positive for BCR-ABL can participate in a separate protocol.

Eligibility: Inclusion Criteria:
  -  Previously untreated BCR-ABL-negative ALL
  -  Age between 25 and 64 years
  -  Performance status between 0 and 3 (ECOG criteria)
  -  Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL); kidneys (serum creatinine level < 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
  -  Written informed consent to participate in the trial
  Exclusion Criteria:
  -  Uncontrolled active infection
  -  Another severe and/or life-threatening disease
  -  Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
  -  Another primary malignancy which is clinically active and/or requires medical interventions
  -  Pregnant and/or lactating women
  -  Past history of renal failure

Relevance to patient case: not relevant