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

Clinical trial: A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

Summary: This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed CD30-positive hematologic malignancy.
  -  Patients with HL must have failed systemic chemotherapy.
  -  Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
  -  Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
  Exclusion Criteria:
  -  Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
  -  History of allogeneic stem cell transplant.
  -  Patients who have had previous treatment with any anti-CD30 antibody.

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

Clinical trial: A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT

Summary: This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.
  The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.


Eligibility: Inclusion Criteria:
  -  Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (<10cm) can be treated individually at the discretion of the responsible physician.
  -  Following histologic subtypes (WHO classification) are eligible for inclusion in the study:
  Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
  NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
  -  Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
  -  formed consent based on oral and written patient information (Appendix I)
  Exclusion Criteria:
  -  Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
  -  Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
  -  WHO Performance Status grade 4 (Appendix II)
  -  Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
  -  Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
  -  Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  -  Patients with seropositivity for the human immunodeficiency virus.
  -  Patients with other active and therapeutically uncontrolled infection.
  -  Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.

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

Clinical trial: Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)

Summary: The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.

Detailed description: Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.

Eligibility: Inclusion Criteria:
  1. The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
  2. Aged 18~75.
  3. Good performance status, ECOG score≤2. Estimated survival span >3 months
  4. Previously untreated.
  5. At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
  6. Good compliance and inform consenting
  7. Fit for the following criteria:
  -  Absolute neutrophil count (ANC)≥1.5×109/L
  -  Platelet（PLT）≥80×109/L
  -  Total bilirubin (TBI) ≤upper normal limit (UNL)
  -  Serum creatine (Cr) ≤UNL
  -  Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL
  Exclusion Criteria:
  1. Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
  2. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
  3. Severe uncontrolled underlying diseases
  4. Pregnancy or lactation
  5. Autoimmune disease history
  6. Severe infection or metabolic diseases
  7. Known allergic to multiple agents, including sulphanilamide.
  8. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
  9. Lymphoma involving central nervous system

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

Clinical trial: A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.


Eligibility: Inclusion Criteria:
  -  Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
  -  Documented anaplastic lymphoma kinase (ALK) status.
  -  Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
  -  Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
  -  Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
  -  At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.
  Exclusion Criteria:
  -  Previous treatment with brentuximab vedotin.
  -  Previously received an allogeneic transplant.
  -  Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
  -  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: Collecting and Storing Blood Samples From Patients With Cancer

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the laboratory may help the study of cancer in the future.
  PURPOSE: This research study is collecting and storing blood samples from patients with cancer.

Detailed description: OBJECTIVES:
  -  To establish a repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey.
  -  To establish a mechanism whereby investigators can analyze correlations between genetic polymorphisms and clinical outcomes (e.g., response to treatment).
  OUTLINE: Additional blood samples are collected for banking from patients while they are scheduled for routine blood draw as a part of their normal care. Samples are stored in a secure place under the control of the Cancer Institute of New Jersey Tissue Retrieval service. The samples may be used for DNA, RNA, or protein extraction and analyses, as well as generation of cell lines.
  Demographic data (ethnicity, race, age, and sex), diagnosis, family history, and previous treatments (chemotherapy, radiation, and surgery) are recorded on the case report form and kept in a secure location in the Office of Human Research Services (OHRS).
  Patients may have their samples removed and destroyed at any time.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed malignancy or bone marrow disorder (i.e., myelodysplasia, myeloproliferative syndrome, or aplastic anemia)
  -  Must be undergoing treatment or planning to undergo treatment at the Cancer Institute of New Jersey
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of non-small cell lung cancer
  -  positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  -  may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  -  Tumors can be measurable or non measurable
  Exclusion Criteria:
  -  prior treatment with PF-02341066
  -  received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  -  current enrollment in another therapeutic clinical trial

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

Clinical trial: A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

Summary: This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.

Detailed description: This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
  -  Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
  -  Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Eligibility: Inclusion Criteria:
  -  Participated in a previous brentuximab vedotin study.
  -  CD30-positive hematologic malignancy.
  -  At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
  Exclusion Criteria:
  Withdrew consent to participate in any prior brentuximab vedotin study.

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

Clinical trial: Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone

Summary: RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about the disease and plan the best treatment.
  PURPOSE: This research study is looking at methemoglobinemia in young patients with hematologic cancer or aplastic anemia treated with dapsone.

Detailed description: OBJECTIVES:
  -  Define the incidence of methemoglobinemia in patients with hematologic malignancy or aplastic anemia who received dapsone prophylaxis through a retrospective chart review encompassing the last 15 years.
  -  Identify major risk factors for developing methemoglobinemia.
  OUTLINE: Medical charts are reviewed. Of particular interest is demographic information, reasons for beginning dapsone prophylaxis, duration of dapsone prophylaxis, dapsone dosing, methemoglobin level, and treatment with methylene blue.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of hematologic malignancy or aplastic anemia
  -  Treated within the past 15 years with dapsone prophylaxis during treatment of primary disease
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Summary: The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).


Eligibility: Inclusion Criteria:
  -  Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
  -  ECOG performance status <2 (Special Populations: <4)
  -  Relapsed or refractory CD30-positive malignancy
  Exclusion Criteria:
  -  Receiving prohibited medication within 4 weeks
  -  Poor liver function (Child-Pugh class C)
  -  Current diagnosis of primary cutaneous ALCL
  -  Acute or chronic graft-versus-host 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 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Eligibility: Inclusion Criteria:
  -  Patients with HL who have received ASCT in the previous 30-45 days
  -  Patients at high risk of residual HL post ASCT
  -  Histologically-confirmed HL
  -  ECOG of 0 or 1
  -  Adequate organ function
  Exclusion Criteria:
  -  Previous treatment with brentuximab vedotin
  -  Previously received an allogeneic transplant
  -  Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
  -  History of another primary malignancy that has not been in remission for at least 3 years
  -  Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents

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

Clinical trial: Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry

Summary: The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials.


Eligibility: Inclusion Criteria:
  -  Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):
  -  Aggressive natural killer (NK)-cell leukemia
  -  Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
  -  Angioimmunoblastic T-cell lymphoma
  -  Anaplastic large cell lymphoma (ALCL), primary systemic type (ALK+, ALK-)
  -  PTCL, not otherwise specified (NOS)
  -  T/NK-cell lymphoma, nasal type
  -  Enteropathy-type intestinal lymphoma
  -  Hepatosplenic T-cell lymphoma
  -  Subcutaneous panniculitis T-cell lymphoma
  -  Transformed mycosis fungoides (at diagnosis of transformation)
  -  T-cell prolymphocytic leukemia (T-PLL)
  -  Cutaneous gamma/delta (γ/δ) T-cell lymphoma
  -  Cutaneous aggressive CD8+ T-cell lymphoma
  -  Hematodermic neoplasms (blastic plasmacytoid dendritic cell neoplasm)
  -  Systemic Epstein Barr Virus (EBV)+ T-cell lymphomas (T-cell lymphoproliferative disorders of childhood)
  -  Other T-Cell lymphomas that are not listed in the Exclusion Criteria
  -  Patient gives written informed consent
  Exclusion Criteria:
  -  Patient has other T- or NK-cell malignancies including:
  -  Precursor T/NK neoplasms
  -  T-cell large granular lymphocytic leukemia
  -  Mycosis fungoides, other than transformed mycosis fungoides
  -  Sézary syndrome
  -  Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis

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 Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Summary: Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.


Eligibility: Inclusion Criteria:
  -  advanced non small cell lung cancer (dose escalation phase)
  -  acquired resistance to erlotinib or gefitinib (expansion phase)
  -  mandatory entrance biopsy (expansion phase)
  Exclusion Criteria:
  -  interstitial lung disease
  -  unstable brain metastases
  -  leptomeningeal disease

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

Clinical trial: An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Summary: This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Eligibility: Inclusion Criteria:
  -  histologically or cytologically proven diagnosis of malignancy other than NSCLC
  -  positive for translocation or inversion event involving the ALK gene locus
  -  positive for ALK amplification events
  -  positive for ALK activating point mutations
  Exclusion Criteria:
  -  mutations of amplifications involving the c-Met gene but not the ALK gene
  -  concurrent treatment on another therapeutic clinical trial
  -  prior therapy specifically directed against ALK

Relevance to patient case: possibly relevant