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

Clinical trial: CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Summary: Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Detailed description: When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.
  Extra blood will be drawn to measure the persistence of CART30 in vivo.

Eligibility: Inclusion Criteria:
  -  Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
  -  Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
  -  Karnofsky or Lansky score greater than 60%.
  -  Expected survival>12 weeks.
  -  Creatinine<2.5mg/dl.
  -  ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.
  -  Bilirubin<2.5mg/dl.
  -  Pulse oximetry of >90% on room air.
  -  Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
  -  Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
  -  Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
  Exclusion Criteria:
  -  Active infection such as hepatitis B or C.
  -  Receive anti-CD30 antibody-based therapy within recent 6 weeks.
  -  Current use of systemic corticosteroids.
  -  Pregnant or lactating.
  -  Confirmed tumor in pulmonary and archenteric tissues.

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

Clinical trial: CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

Summary: Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.

Detailed description: A large number of lymphoma patients exhaust current treatment options and die from the disease. Innovative therapy is urgently needed. Chimeric antigen receptor (CAR)-modified T cells have demonstrated unprecedented successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. Besides CD19 lymphomas, many lymphomas are CD30 positive and therefore, CD30-CAR T cells may prove to be effective in treating such patients. We have developed several generations of CD30 CARs. Preclinical studies have demonstrated effective killing of CD30 target cells. In this study, two versions of CD30 CARs, both of which are 4th generation CARs with a self-withdrawal mechanism (FKBP-iCasp9), will be evaluated in CD30 lymphoma patients. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility: Inclusion Criteria:
  -  Relapsed or refractory CD30(+) lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry.
  -  Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  -  Age≥18.
  -  Pulse oximetry of > 90% on room air.
  -  Adequate hepatic function, defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN), aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
  -  Adequate renal function, defined as serum creatinine <2.0mg/dl.
  -  Adequate heart function with LVEF≥50%
  -  Hb≥80g/L
  -  Measurable disease can be identified.
  -  Life expectancy ≥3 months.
  -  Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom.
  -  Patients must sign an informed consent.
  Exclusion Criteria:
  -  Uncontrolled active infection.
  -  Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
  -  HIV positive
  -  Pregnant or lactating.
  -  Currently enrolled in another clinical trial.
  -  Concurrent use of systemic steroids.

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

Clinical trial: Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Summary: A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)


Eligibility: Inclusion:
  1. Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.
  2. Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded).
  3. Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded.
  4. Patient has a World Health Organization (WHO) performance status 0-2.
  Exclusion:
  1. Prior treatment with an ALK inhibitor other than crizotinib.
  2. History of carcinomatous meningitis.
  3. Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.
  5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
  7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.

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 Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

Summary: This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
  -  Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
  -  Presence of at least one measurable lesion as defined by RECIST 1.1
  -  Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
  -  Patient has a WHO performance status 0-1
  Exclusion Criteria:
  -  Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
  -  Patients with an active, known or suspected autoimmune disease
  -  Unable or unwilling to swallow tablets or capsules
  -  Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results

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

Clinical trial: Ceritinib Rare Indications Study in ALK+ Tumors

Summary: This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).


Eligibility: Inclusion Criteria:
  -  Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) other than Non-Small Cell Lung Cancer (NSCLC).
  -  Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory.
  -  Patient has WHO Performance Status (PS) ≤ 2
  -  Patient must have received at least one line of prior systemic treatment for recurrent, locally advanced and/or metastatic disease, may have discontinued for:
  -  Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM and by Cheson assessment criteria for lymphoma
  -  Intolerance described as any discontinuation due to an AE of any grade despite appropriate supportive treatment
  -  Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
  Exclusion Criteria:
  -  Patient has ALK+lung cancer
  -  Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient with acute or chronic GI disease that may significantly alter the absorption of ceritinib.
  -  Patient with a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  -  Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  -  Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).
  -  Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing for viral hepatitis is not mandatory).
  -  Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).

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

Clinical trial: A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

Summary: The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.

Detailed description: ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.

Eligibility: Inclusion Criteria:
  -  primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
  -  ECOG 0-2
  -  more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
  -  estimated survival >/3months
  -  Age 18-65 years
  -  Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
  -  Signature of informed consent
  Exclusion Criteria:
  -  Age <\ 18years
  -  without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
  -  without measurable lesions
  -  being treated by other drugs in other clinical trials
  -  Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
  -  Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
  -  Renal insufficiency: more than 2 times higher than that of normal serum creatinine
  -  Blood screening period: WBC < 1 * 109/L * 109/L; platelet < 25; Hb < 60g/L
  -  HIV test positive

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

Clinical trial: ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)

Summary: Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.
  Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.

Detailed description: The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.
  The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed lung cancer and tissue availability for ALK analysis.
  Exclusion Criteria:
  -  Not lung cancer

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

Clinical trial: Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
  -  Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
  -  Prior CNS or leptomeningeal metastases allowed if asymptomatic
  -  Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
  -  Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  -  For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
  Exclusion Criteria:
  -  Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal [GI] cancer by endoscopic resection or in situ carcinoma of the cervix)
  -  Participants who have received any previous ALK inhibitor other than crizotinib
  -  Any GI disorder that may affect absorption of oral medications

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

Clinical trial: A Retrospective Study of Clinical, Phenotypic and Genetic Factors of Peripheral T-Cell Lymphomas

Summary: The purpose of this study is to establish the distribution of peripheral T-cell lymphocyte (PTCL) subtypes by re-analysis and re-classification of samples according to the 2008 World Health Organization (WHO) classification of lymphoid neoplasms.

Detailed description: This study is a retrospective, non-interventional and, post-authorization observational study of other designs (PAS-OD).
  This multicenter trial will be conducted in Spain. Retrospective review of medical records and initial tumor biopsies of participants diagnosed with PTCL in the period of 6 years between 01/01/2008 and 31/12/2013 will be performed. Initial tumor biopsies and histological preparations, filed and previously anonymized, will be sent to the central laboratory for assessment.

Eligibility: Inclusion Criteria:
  -  Participants diagnosed with PTCL in the six years between 01/01/2008 and 31/12/2013.
  -  Availability of initial tumor biopsy diagnosis in paraffin block (node or core biopsy of 16-18mm).
  -  PTCL subtypes permitted by WHO 2008 classification of lymphoid neoplasms:
  -  Natural killer/ T-lymphocytes (NK /T-cell) lymphoma extranodal nasal type
  -  Enteropathic T-cell lymphoma
  -  Hepatosplenic T-cell lymphoma
  -  Peripheral T-cell lymphoma, not otherwise specified
  -  Angioimmunoblastic T-cell lymphoma
  -  Anaplastic large cell lymphoma, Anaplastic lymphoma kinase positive (ALK)+
  -  Anaplastic large cell lymphoma, ALK-
  Exclusion Criteria:
  • Participants with an unavailable history (lost, empty or not recoverable).

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

Clinical trial: Study of the Biological Mechanisms Associated With the Immunogenicity in Anaplastic Large Cell Lymphoma ( ALCL ) ALK +

Summary: To study the correlation between the polymorphism of the main immunity genes and progression-free survival in ALCL of the child.


Eligibility: Inclusion Criteria:
  -  Every patients treated according to COPAD-IGR, HM 89,91 and 97 and ALCL99 protocols and included in related studies
  -  Clinical data registered in SFCE database
  -  Signed consent form
  Exclusion Criteria:
  -  No ALK expression on tumour
  -  No consent signed

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

Clinical trial: The Value and Mechanisms for Monocytes Subpopulations in Predicting the Prognosis of Lymphomas

Summary: The purpose of this study is to determine whether the CD16- monocyte/CD16+ monocyte ratio could help predict the prognosis of DLBCL and PTCL.

Detailed description: The investigators plan to prospectively involve 100 non-hodgekin lymphoma patients, including 50 diffuse large B cell lymphomas and 50 peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.
  The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.
  All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by enhanced computed tomography or PET-CT.
  The peripheral blood would be collected. The Cytodiff flow cytometric technique would be used to test 16 leukocyte subpopulations from peripheral blood at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression.
  Progression-free survival (PFS) and overall survival (OS) would be estimated using the Kaplan-Meier method and two-tailed log-rank test.The Cox proportional hazards model would evaluate prognostic factors for OS and PFS. Specificity, sensitivity and cut-off would be established using time-dependent receiver operating characteristic (ROC) curve analysis. Area under curve (AUC) values >0.7 indicate that the parameter can be used for diagnosis, with values >0.9 indicating high clinical accuracy.

Eligibility: Inclusion Criteria:
  1. pathologically confirmed diffuse large B cell lymphoma (DLBCL nos, PCNSL, ALK+ DLBCL, DLBCL/BL) or peripheral T cell lymphoma (AITL, ALCL, PTCL nos, NK/T nasal type, EATL, HSTL)
  2. no treatment before
  3. hCG(-)
  4. 18 years old to 80 years old
  Exclusion Criteria:
  1. other tumors
  2. severe infections

Relevance to patient case: not relevant