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

Clinical trial: Pegteograstim in Children With Solid Tumors

Summary: To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Detailed description: Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Eligibility: Inclusion Criteria:
  -  Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
  Exclusion Criteria:
  -  Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
  -  Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
  -  Patients with bleeding tendency to whom subcutaneous injection should be avoided.
  -  Active infection or infectious fever during the screening period.
  -  Genetic problem to fructose tolerance.
  -  Patients who participated in other clinical trial within 4 weeks before enrollment.
  -  Pregnant and nursing women

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

Clinical trial: Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia

Summary: Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.
  Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.
  Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.


Eligibility: Inclusion Criteria:
  -  Patient > 15 years old
  -  Newly diagnosed AML or post myelodysplastic syndrome (MDS)
  Exclusion Criteria:
  -  Patients with M3 AML of French-American-British (FAB) classification (APL, Acute Promyelocytic Leukemia)
  -  World Health Organization (WHO) performance status >2; (ii)
  -  Left ventricular systolic ejection fraction below the normal range
  -  Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  -  Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
  -  AST or ALT levels > 2.0 x upper limit of normal (ULN), except if AML-related

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

Clinical trial: Institut Paoli Calmettes Acute Leukemia Database

Summary: Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia


Eligibility: Inclusion Criteria:
  -  Patient with a diagnosis of acute leukemia
  Exclusion Criteria:
  -  Non applicable

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

Clinical trial: Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

Summary: Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia


Eligibility: Inclusion Criteria:
  -  Diagnosis of chronic lymphatic leukemia
  Exclusion Criteria:
  -  Score of Matutes <4

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

Clinical trial: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

Summary: It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

Detailed description: Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival.
  CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.
  A first multicenter study entitled STIM trial demonstrated that imatinib could be safely discontinued in patients with complete molecular remission (CMR) for at least 2 years (undetectable BCR-ABL1 transcript by RT-qPCR).
  Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation. All molecular relapsing patients were sensitive when imatinib was re-challenged.
  The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in order to evaluate their molecular status, vital status and ongoing treatment in patient with a first molecular relapse.
  This long term follow up will allow us to predict if a constant long term control of the disease is possible and to better define the clinical and biological CML-related factors predictive for a molecular relapse after TKI discontinuation.

Eligibility: Inclusion Criteria:
  -  The patients should have been included in the STIM1 Study CHUBX 2006/06 (NCT00478985)
  Exclusion Criteria:
  -  The patients not included or discharged prematurely from the STIM1 Study can not participate to the study

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

Clinical trial: Transfusion in Adult Acute Myeloid Leukemia

Summary: Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.
  Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.
  Based on these data, we retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.


Eligibility: Inclusion Criteria:
  -  Patient > 15 years old
  -  Newly diagnosed AML or post myelodysplastic syndrome (MDS)
  Exclusion Criteria:
  -  Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)
  -  World Health Organization (WHO) performance status >2;
  -  Left ventricular systolic ejection fraction below the normal range
  -  Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  -  Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
  -  AST or ALT levels > 2.0 x ULN, except if AML-related

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

Clinical trial: Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan

Summary: This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed

Detailed description: Primary objectives
  Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response :
  -  Complete hematologic response (CHR) at 3 months;
  -  Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases);
  -  Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale];
  Assess the safety and tolerability of Cemivil after one year of treatment, based on:
  -  Incidence, severity, and relationship of adverse events (AEs) to the study medication;
  -  Serious AEs;
  -  AEs leading to permanent treatment discontinuation;
  -  Clinically relevant changes in laboratory tests (according to laboratory reference ranges).
  Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy "first-line patients". N=58 switched from patented imatinib to generic imatinib "switched patients")

Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR
  -  Written informed consent
  Exclusion Criteria:
  -  Age <18 years
  -  CML in accelerated phase
  -  CML in blast crisis
  -  CML with mutation(s) in the BCR-ABL gene
  -  Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Summary: RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new tumors from growing. Combining these therapies may be an effective treatment for colorectal cancer that has spread to the liver.
  PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by chemotherapy delivered directly into the blood vessels of the liver in treating patients who have colorectal cancer that has spread to the liver.

Detailed description: OBJECTIVES: I. Determine the safety and efficacy of radiofrequency tissue ablation followed by hepatic arterial chemotherapy with floxuridine and fluorouracil in patients with colorectal cancer metastatic to the liver.
  OUTLINE: Patients undergo an open laparotomy to identify the target tumor in the liver using intraoperative ultrasound followed by radiofrequency tissue ablation over 20 minutes to each tumor and placement of hepatic arterial catheter. Within 35 days postoperatively, patients receive hepatic arterial chemotherapy consisting of floxuridine on days 1-7 and fluorouracil over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses. Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer metastatic to the liver No preoperative or intraoperative evidence of extrahepatic metastasis including clinical, radiographic, gross or microscopic evidence Tumors must be no more than 4 cm in diameter No more than 6 total tumors May have failed prior systemic chemotherapy Failure of 1 prior intra-arterial regimen excluding floxuridine, fluorouracil, or another fluoropyrimidine allowed if liver enzymes recovered No evidence of cirrhosis No gross ascites
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 16 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active duodenal or gastric ulcers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6-8 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to the liver Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Liposomal Doxorubicin in Treating Patients With Advanced Stomach Cancer

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 liposomal doxorubicin in treating patients who have advanced stomach cancer.

Detailed description: OBJECTIVES: I. Determine overall survival, time to disease progression, objective reponse rate, safety profile, and quality of life in patients with inoperable gastric adenocarcinoma when treated with doxorubicin HCl liposome.
  OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour every 4 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease may continue therapy past the 6 courses until documented disease progression. Quality of life is assessed prior to every treatment course. All patients are followed at 1 month. Patients with stable or responding disease are then followed every 3 months until death.
  PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 24 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced gastric adenocarcinoma, including adenocarcinoma of the esophagogastric junction Evaluable disease No CNS involvement
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin normal AST or ALT less than 3 times upper limit of normal (ULN) (5 times ULN if documented liver metastases) Renal: Creatinine less than 1.5 times ULN Cardiovascular: LVEF normal No history of New York Heart Association class II-IV heart disease with congestive heart failure No unstable cardiovascular disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior primary cancer within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No hypersensitivity to anthracycline therapy No history of severe hypersensitivity reactions to products containing Chremophor EL (e.g., cyclosporine or teniposide for injection concentrate) No other significant medical disorder (e.g., active uncontrolled infection) that would preclude study treatment
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to less than 1/3 of hematopoietic sites and recovered Surgery: Not specified Other: At least 30 days since other prior investigational agents

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer

Summary: EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.


Eligibility: Inclusion Criteria:
  -  Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
  -  Immunohistochemical evidence of tumor EGFR (HER-1) expression
  -  At least one measurable lesion according to the WHO criteria
  -  Life expectancy ≥ 12 weeks
  -  ECOG performance status 0-1
  Exclusion Criteria:
  -  History of prior MAb therapy
  -  History of prior treatment with an EGFR (HER-1) directed therapy
  -  Known brain metastases
  -  Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
  -  Known intercurrent infections or immunosuppression
  -  Actively infected with, or chronic carriers of HBV
  -  Evidence of HCV disease
  -  Previous diagnosis of autoimmune disease
  -  Known hypersensitivity to the administered drugs or any of their components
  -  Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction

Summary: The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.


Eligibility: Inclusion Criteria:
  -  Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.
  -  Disease measurable in at least one dimension.
  -  Target tumors outside of prior radiation field(s).
  -  An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1
  -  Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
  -  Adequate renal function, as determined by serum creatinine and serum albumin measurements.
  -  Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be <= 5.0x ULN if due to metastatic disease in the liver.
  -  Fully recovered from prior surgery.
  -  No history of hemorrhagic cystitis.
  -  No microscopic hematuria (>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin.
  -  Capable of understanding the protocol requirements and risks and providing written informed consent.
  Exclusion Criteria:
  -  Concurrent serious medical illness unrelated to tumor within the past 6 months.
  -  Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
  -  Positive screening pregnancy test or is breast-feeding.
  -  Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
  -  Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks.
  -  History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years.
  -  Known or clinically suspected brain metastases.
  -  Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction.
  -  Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy
  -  Received any investigational drug within the last 30 days.
  -  Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
  -  Prior treatment with a camptothecin analog.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Safety Study of EMD 72000 in Combination With ECX (Epirubicin, Cisplatin and Capecitabine) in Oesophagogastric Cancer

Summary: The main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, EMD 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ECX (epirubicin, cisplatin and capecitabine).
  In addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).


Eligibility: Inclusion Criteria:
  -  Advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
  -  EGFR positive tumor
  -  KPS greater than 60
  -  Normal cardiac function
  -  Adequate liver and bone marrow function
  -  GFR greater than 60 ml/minute
  Exclusion Criteria:
  -  Previous chemotherapy
  -  Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias
  -  Clinically significant ECG or cardiac history
  -  Radiotherapy or surgery within last 4 weeks

Relevance to patient case: definitely relevant