araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

Summary: The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.
  Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.


Eligibility: Acute Myeloid Leukemia-Intensive Chemotherapy
  Inclusion Criteria:
  -  Diagnosis of AML according to WHO criteria
  -  Age greater than 18 years
  -  Performance status (ECOG) between 0-2
  -  Adequate liver and kidney function
  -  Signed Informed Consent form
  -  No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
  -  Adequate contraception for fertile men and women
  -  Eligible for intensive chemotherapy (as judged by the treating physician)
  Exclusion Criteria:
  -  Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)
  -  Pregnant women
  -  HIV-positivity
  -  New York Heart Association class III and IV congestive heart failure
  -  Patient refuses to use adequate contraception
  -  History of hypersensibility to any of the used chemotherapy drugs
  -  Patient refuses to sign informed consent form
  Acute Myeloid Leukemia-Non-Intensive Chemotherapy
  Inclusion Criteria:
  -  Diagnosis of AML according to WHO criteria
  -  Age greater than 18 years
  -  Signed Informed Consent form
  -  No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
  -  Adequate contraception for fertile men and women
  -  Non-eligible for intensive chemotherapy (as judged by the treating physician)
  Exclusion Criteria:
  -  Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)
  -  Pregnant women
  -  HIV-positivity
  -  Patient refuses to use adequate contraception
  -  History of hypersensibility to any of the used chemotherapy drugs
  -  Patient refuses to sign informed consent form
  Chronic Myeloid Disorders:
  Inclusion Criteria:
  -  Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria
  -  Age greater than 18 years
  -  Signed Informed Consent form
  Exclusion Criteria:
  -  Patient refuses to sign informed consent form

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Early Response Assessment of Induction Chemotherapy in Acute Myeloid Leukemia Patients Using F-18 FLT PET/CT

Summary: The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Detailed description: Assessment of treatment response in AML is very important to determine the next treatment. Standard treatment of AML begins with induction chemotherapy. NCCN guideline recommend to assess the treatment response via bone marrow examination approximately 7-10 days after completion of induction chemotherapy. However, the possibility of sampling error and risks of infection and bleeding are the limitation of bone marrow biopsy.
  F-18 fluorodeoxythymidine (FLT) is a radiopharmaceutical for PET, reflecting the proliferation of the cell. F-18 FLT is trapped after phosphorylation by thymidine kinase1, whose expression is increased in replicating cells. There have been several studies that reported F-18 FLT PET could measure health and proliferation of the bone marrow.
  The aim of this study is to evaluate if F-18 FLT PET/CT is suitable for early response assessment of induction chemotherapy in acute myeloid leukemia patients.

Eligibility: Inclusion Criteria:
  -  acute myeloid leukemia
  -  must receive induction chemotherapy
  -  19 years old and over
  Exclusion Criteria:
  -  no standard therapy
  -  pregnancy

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Expanded Access /Compassionate Use Protocol For Relapsed Or Refractory CD33 Positive AML Patients In The USA Without Access To Comparable Or Alternative Therapy

Summary: An expanded access/compassionate use protocol that allows access to Mylotarg for relapsed/refractory AML CD33 positive patients in the USA.
  Contact: B1761026@iconplc.com

Detailed description: Contact:
  B1761026@iconplc.com

Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of relapsed/refractory AML (defined as >=5% marrow blasts by morphology), including MDS, with persisting rising blasts and no other comparable or satisfactory alternative therapy available. If bone marrow has <5% blasts by morphology but the patient has evidence of relapse with extra-medullary disease progression. In select cases presenting with conversion of MRD from negative to positive, treatment with GO may be allowed where no alternative treatments are feasible.
  OR
  -  Confirmed diagnosis of relapsed or refractory APL with persisting or rising leukemic burden (either by morphology, cytogenetic analysis or by molecular techniques), and no other comparable or satisfactory alternative therapy available.
  -  Documentation that malignant cells express CD33
  4) Age >=3 months
  5) Adequate non-hematologic organ function
  Exclusion Criteria:
  -  Untreated AML and MDS or AML and MDS in complete remission.
  -  Patients with a known history of VOD/SOS.
  -  Patients with a known hypersensitivity to Mylotarg or its parts: hP67.6 antibody, calicheamicin derivatives or other ingredients.
  -  Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

Summary: This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.

Detailed description: This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.

Eligibility: Inclusion Criteria:
  -  A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
  -  The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
  -  The age of the patient is between 18 years old and 70 years old.
  -  The condition of the patient permits the procedure of chemotherapy using PCV schema.
  -  The patient is informed consent, and willing to join in this research.
  Exclusion Criteria:
  -  The diagnosis is not recurrent high-grade glioma.
  -  The diagnosis of high-grade glioma was not established by pathological method.
  -  No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
  -  The age of the patient does not meet the requirement of this research.
  -  The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
  -  There are other conditions that the clinicians believe that the PCV chemotherapy is not appropriate for the patient.
  -  The patient is not willing to join in this research.

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Summary: A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.


Eligibility: Inclusion Criteria:
  -  Documented IDH1R132-mutant tumors
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  -  Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
  -  Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
  -  Acute Promyelocytic Leukemia
  -  Women who are pregnant or lactating
  Other protocol-defined Inclusion/Exclusion may apply

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens

Summary: The purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).

Detailed description: Many studies have demonstrated that Iron is essential for the metabolism, cell cycle regulation and metastasis in different cancer cell lines. It is also believed that Iron concentration will increase in cancer cells by enhancing expression of TFR-1 receptors and in case of receptor saturation, non-receptor-mediated pinocytosis would be a significant pathway for more iron intake. Iron deficiency may lead to increase P 53 which consequently will stop cell mitosis in G1-S state. It also increases expression of N-myc down-regulated gene 1 which can suppress metastasis in cancer. It has been suggested that Iron chelators may decrease leukemic tumor growth in animal models of acute myeloid leukemia (AML). Some other case studies demonstrated the role of Iron chelators in relapse and/or refractory AML. Finally a phase 1 clinical study is undertaken for evaluate the role of Tiapine and cytarabine for adult AML and high-risk myelodysplastic syndrome. So in this study the investigators try to evaluate the role of iron chelating agent (deferasirox) for patients with acute lymphatic leukemia (ALL) and AML patients who cannot be treated with standard chemotherapy regimes .

Eligibility: Inclusion Criteria:
  1. Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons:
  1. age > 65
  2. existence of another illness, such as heart failure (EF> 40)
  2. Ferritin < 500 μg / l
  3. Not existence of other co morbidity
  4. GFR > 40
  Exclusion Criteria:
  1. GFR < 40
  2. Control group become iron overloaded (Ferritin > 500 μg /l)
  3. Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
  4. Not willing to continue treatment.

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Non Invasive Detection of IDH1/2 Mutation in Gliomas

Summary: This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.
  In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.
  In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.

Detailed description: The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.
  The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).
  The secondary endpoints include:
  1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
  2. Differentiation of tumor recurrence from radiation induced changes
  3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction

Eligibility: Inclusion criteria
  1. Affiliation to a social security system
  2. Patient≥ 18 years old
  3. Written informed consent
  4. One of the two situations:
  -  presumed grade II-III glioma candidate to surgery (group 1)
  -  IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)
  5. Evaluable tumoral mass min diameter >2 cm (FLAIR)
  6. PKPS > 60
  Exclusion criteria
  1. Contra-indication to MRI
  2. Patient unable to give an written Informed Consent
  3. Patient under guardianship or deprived of freedom
  4. For group 2: patient already included in group 1

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

Summary: The purpose of this study is to evaluate the efficacy and feasibility of combination chemotherapy with target agents according to the result of targeted deep sequencing in pediatric patients with relapsed/refractory solid tumor or AML.

Detailed description: Outcome of pediatric cancer has been improved substantially over the past few decades, but the prognosis of relapsed/refractory pediatric cancer still remains poor. Advances in genomic technologies have improved the ability to detect diverse somatic and germline genomic aberrations of cancer patients, and it has been incorporated in the clinical management of cancer.
  Samsung Genomic Institute developed a targeted next-generation sequencing (NGS) platform, CancerSCAN™, which can detect clinically significant genomic aberrations of tumors. In this study, tumor samples of refractory/relapsed pediatric cancer patients will be tested with CancerSCAN™ and the patients will receive combination chemotherapy with matched single-targeted agent or multi-targeted receptor tyrosine kinase inhibitor according to the result of CancerSCAN™.
  I. Relapsed/refractory solid tumor
  -  Perform CancerSCAN™ at enrollment
  -  Conventional chemotherapy (ifosfamide, carboplatin, etoposide) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™
  II. Relapsed/refractory AML
  -  Perform CancerSCAN™ at enrollment
  -  Conventional chemotherapy (fludarabine, cytarabine) with matched single-targeted agent (axitinib, crizotinib, dasatinib, erlotinib, everolimus, imatinib, pazopanib, ruxolitinib, sorafenib, vandetanib, vemurafenib, or trastuzumab) or multi-targeted receptor tyrosine kinase inhibitor (pazopanib or sorafenib) according to the result of CancerSCAN™

Eligibility: Inclusion Criteria:
  -  Under 18 years of age at initial diagnosis
  -  Patients with refractory/relapsed solid tumor or AML (Solid tumor: Stable or progressive disease after 1st-line treatment or relapse; AML: Persistence after 2 cycles of induction chemotherapy or relapse)
  -  Patient with tumor sample which is adequate for targeted deep sequencing
  Exclusion Criteria:
  -  Patients who had salvage chemotherapy previously
  -  Patients with organ dysfunction as follows (creatinine elevation ≥ 3 x upper limit of normal (ULN), ejection fraction <40%, significant arrhythmia or conduction disturbance)
  -  Patients who are not eligible to have scheduled treatment due to the other significant impaired organ function
  -  Patients whose tumor samples are not sufficient for targeted deep sequencing
  -  Pregnant or nursing women

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Samples From Leukemia Patients and Their Donors to Identify Specific Antigens

Summary: The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

Detailed description: It is well known that tumor cells and leukemia cells express different surface structures (called antigens) that can serve as targets for cancer cell destruction by the immune system. Effective immune therapies are characterized by high specificity and low toxicity. One of the major obstacles impeding the use of these therapies as standard of care is the identification of good target antigens. In acute myeloid leukemia (AML) there is major patient to patient variation in leukemia antigens, so there is no universal AML cell target. Rather, each patient has a unique array of potential cell targets. Thanks to the rapid progress of new DNA/RNA sequencing technologies, the identification of these unique, patient-specific leukemia cell antigen-targets is now possible.
  The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

Eligibility: Inclusion Criteria:
  -  Diagnosis of Leukemia with plan to receive a bone marrow transplant
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

Summary: Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

Detailed description: Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and >30 days elapses from one to other admission (episode).
  Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.
  In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.
  Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

Eligibility: Inclusion Criteria:
  -  admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia
  Exclusion Criteria:
  -  prior documentation of invasive fusariosis or allergy to azoles

Relevance to patient case: not relevant
Patient case: 1-year-old male with acute myeloid leukemia; genetic feature: IDH1

Clinical trial: Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With AML or MDS With an IDH1 Mutation

Summary: This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules. Approximately 48 patients will be enrolled in the dose-escalation portion of this study in one or more schedules followed by approximately 14 patients in expansion cohorts


Eligibility: Inclusion Criteria:
  -  Pathologically proven acute myeloid leukemia or high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) that is either relapsed or refractory to standard therapy, or for whom standard treatments are contraindicated.
  -  Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  -  Good kidney and liver function
  -  No prior organ allograft
  -  For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 90 days after
  Exclusion Criteria:
  -  Previously treated with any prior IDH1 targeted therapy
  -  History of prior malignancy unless disease free for > 2 years.
  -  Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  -  Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
  -  Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g. malabsorption, gastric or small bowel resection, etc.) deemed to jeopardize intestinal absorption
  -  Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
  -  Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  -  Known HIV positivity
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Relevance to patient case: not relevant