araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.


Eligibility: Inclusion Criteria:
  -  Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
  -  Positive for translocation or inversion events involving the ALK gene locus
  -  No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
  -  Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures.
  -  18 years of age or older with the exception of India which has an upper age limit of 65 years old
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial.
  -  Prior therapy directly targeting ALK.
  -  Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
  -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  -  Pregnancy or breastfeeding.
  -  Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
  -  Known HIV infection
  -  Known interstitial lung disease or interstitial fibrosis
  -  Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

Summary: Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Detailed description: Non small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  -  Metastatic disease treated with gefitinib or erlotinib
  -  Presence of at least one measurable lesion according to RECIST criteria
  Exclusion Criteria:
  -  No tumor tissue available
  -  No clinical data available

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Summary: The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Detailed description: The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Eligibility: Inclusion Criteria:
  -  Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
  -  Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
  Exclusion Criteria:
  -  History of another primary malignancy that has not been in remission for at least 3 years
  -  Known cerebral/meningeal disease
  -  Peripheral neuropathy of grade 2 or greater
  -  Females who are pregnant or breastfeeding

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

Summary: The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.


Eligibility: Inclusion Criteria:
  -  Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
  -  Measurable disease of at least 1.5 cm
  -  ECOG performance status less than or equal to 2
  Exclusion Criteria:
  -  Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
  -  Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
  -  History of another primary malignancy that has not been in remission for at least 3 years
  -  Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
  -  Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
  -  Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell Lymphoma

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.

Detailed description: OBJECTIVES:
  -  To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
  -  To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.
  OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of anaplastic large cell lymphoma
  -  Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Summary: This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).


Eligibility: Inclusion Criteria:
  -  Histologically-confirmed NHL (DLBCL only for Parts B and C)
  -  Relapsed or refractory disease following at least 1 prior systemic therapy
  -  Measurable disease of at least 1.5 cm as documented by CT
  -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  Exclusion Criteria:
  -  History of another primary invasive malignancy that has not been in remission for at least 3 years
  -  Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  -  B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  -  Known cerebral/meningeal disease

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)

Summary: The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).


Eligibility: Inclusion Criteria:
  -  Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
  -  Patients with histologically confirmed diagnosis of the following:
  -  Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
  -  Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
  -  Angioimmunoblastic T-cell Lymphoma (AITL)
  -  Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
  -  Have at least 1 evaluable lesion
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  -  Life expectancy of at least 3 months

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer

Summary: This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).


Eligibility: Inclusion Criteria:
  -  Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
  -  Positive for translocation or inversion events involving the ALK gene locus
  -  Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
  -  Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial.
  -  Prior therapy directly targeting ALK.
  -  Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
  -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  -  Pregnancy or breastfeeding.
  -  Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
  -  Known HIV infection
  -  Known interstitial lung disease or interstitial fibrosis
  -  Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients

Summary: This study will be a pilot study of sorafenib 400mg PO twice daily in refractory T-cell lymphomas including peripheral T-cell lymphoma (PTCL), angioimmunoblastic lymphadenopathy (AILD), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and other transformed T-cell lymphomas with the primary objective of studying the biological effects of the multikinase inhibitor, sorafenib.

Detailed description: Primary objectives:
  • To study the biological effects of sorafenib 400mg BID on the mitogen-activated protein kinase (MAPK) pathway, specifically the inhibition of extracellular signal-regulated kinases (ERK) phosphorylation, and to correlate with clinical activity in patients with T-cell lymphoma.
  Secondary objectives:
  -  To observe the clinical activity of sorafenib 400mg BID by determining response rate, and progression free survival in patients with T-cell lymphoma. Duration of response and duration of stable disease will also be measured.
  -  To determine the tolerability of sorafenib in patients with T-cell lymphoma.
  Exploratory objectives:
  -  To observe the effects of sorafenib on T-cell subsets (CD4/CD8 ratio, and Tregs), and the effects of sorafenib on the monocytoid population.
  -  To observe the effects of sorafenib on the serum cytokine profile.
  -  To observe the effects of sorafenib on the T-cell receptor pathway, i.e. Lck, ZAP-70, and Syk.
  -  To observe changes in lymph node or skin morphology including tumor cell infiltrate, vasculature, and the tumor microenvironment in patients treated with sorafenib by performing serial biopsies of lymph nodes or skin.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and Alk-), and other transformed T-cell lymphomas
  -  Age > 18 years old
  -  Measureable disease, as defined by the Cheson criteria
  -  ECOG Performance Status of 0 or 1
  -  Life expectancy > 12 weeks
  -  Adequate bone marrow, liver and renal function
  -  Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets 50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by T-cell lymphoma will also be eligible
  Exclusion Criteria:
  -  Prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib.
  -  Prior treatment with allogeneic stem cell transplant
  -  Cardiac disease: Congestive heart failure > class II NYHA.

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Summary: The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) .
  The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.

Detailed description: The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with XALKORI® (crizotinib).

Eligibility: Inclusion Criteria:
  -  Well stained slides with bright FISH signals
  Exclusion Criteria:
  -  Very old slides that were already bleached

Relevance to patient case: not relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Summary: Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase (ALK)


Eligibility: Inclusion Criteria:
  -  Patients with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
  -  Only patients with tumors characterized by genetic alterations in ALK. For non-small cell lung cancer (NSCLC), an ALK translocation must be detected by Fluorescent in situ hybridization (FISH) in ≥15% of tumor cells. Local site documented results on ALK alteration are acceptable for enrollment of the patients. Central confirmation of local results is not required.
  --Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
  -  Adequate organ function
  -  Dose-expansion part: Patients must have NSCLC that has progressed since prior therapy with alectinib. Alectinib must have been the only prior ALK inhibitor received by the patient prior to trial entry.
  Exclusion Criteria:
  -  Patients with symptomatic Central Nerve System (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
  -  Patients with unresolved nausea, vomiting or diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  -  Other concurrent severe and/or uncontrolled medical conditions
  -  Patients who have been treated with chemotherapy or biologic therapy or other investigational agent < 2 weeks prior to starting the daily dosing of the study drug for compounds with a half-life ≤ 3 days, and < 4 weeks prior to starting the daily dosing of the study drug for compounds with a prolonged half-life (< 6 weeks for patients that received nitrosoureas or mitomycin-C)
  -  Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis and the Principal Investigator and documented
  -  Patients who have received radiotherapy to lung within 4 weeks prior to starting the daily dosing of the study drug or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites radiotherapy to a large volume (including whole brain radiotherapy) < 2 weeks prior to starting the daily dosing of the study drug, and patients who have received radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) < 3 days prior to starting the study drug.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: possibly relevant
Patient case: 18-year-old male with anaplastic large cell lymphoma; genetic feature: ALK

Clinical trial: Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Summary: The purpose of this study is to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.

Detailed description: LDK378 is a novel inhibitor of ALK that is active in a broad range of ALK-activated tumor models, including models driven by mutated versions of ALK known to be resistant to crizotinib, and by ALK gene amplification.
  The primary purpose of this study is to determine the maximum tolerated dose and/or recommended dose for expansion in pediatric patients, and to delineate a clinical dose to be used in any future pediatric studies, with and without food. This study will also assess the safety, tolerability, PK and preliminary evidence of antitumor activity of LDK378 in pediatric patients with neuroblastoma, and other ALK-activated tumors.

Eligibility: Inclusion Criteria:
  -  Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
  -  Age ≥ 12 months and < 18 years
  -  The tumor must carry a genetic alteration of ALK
  -  Patients must have evaluable or measurable disease
  Exclusion criteria:
  -  Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
  -  Clinically significant, uncontrolled heart disease
  -  Inadequate end organ function as defined by specified laboratory values
  -  Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
  -  Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study.
  -  History of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
  -  History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  -  Medications with a known risk of prolongation of QT interval
  Other protocol defined inclusion and exclusion criteria may apply

Relevance to patient case: not relevant