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

Clinical trial: AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years

Summary: AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia.

Detailed description: AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. A rapid analysis of risk-factors (cytogenetics, FLT3 status, clearance of blasts after first induction) and the donor situation is of utmost importance. For this "fast search" diagnostic, which is accomplished in all enclosed patients, significant resources are provided, to take the load off the participating centers. Furthermore, the relevance of autologous transplantation and the benefit of additional substances within the postremission therapy such as m-AMSA or mitoxantrone will be investigated. There is an up-front randomisation in four therapy arms with two cross-classifying factors of two stages (intensified vs. standard therapy and Ara C vs. Ara C+ mitoxantrone + m-AMSA). Thus, the intergroup treatment schedule of the German Competence Network is integrated into the AML2003 study as a central element and 25% of the patients are treated accordingly. In the intensified therapy arms a risk-adapted and priority-based therapy is implemented, including early allogeneic and consolidating autologous stem cell transplantation, respectively. In addition to the clinical questions , a detailed concomitant research program was initiated for the AML2003 study, to get a better view of the heterogeneity of AML and to open new ways for "custom-made" therapies.

Eligibility: Inclusion Criteria:
  -  de novo or secondary acute myeloid leukemia FAB-subtypes M0-M2 and M4-M7
  -  de novo or secondary myelodysplastic syndrome WHO-type RAEB-2
  -  age 16 to 60 years
  -  written informed consent
  Exclusion Criteria:
  -  severe comorbidities
  -  severe, uncontrolled complications of the leukemia
  -  prior therapy for AML/MDS
  -  other simultaneous hematological malignancies
  -  HIV-Infection
  -  known allergies against study medication
  -  pregnancy
  -  missing written informed consent

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

Clinical trial: Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

Summary: The purpose of the study is to evaluate the overall and disease free survival of recipients who have received G-CSF mobilized stem cells from HLA matched sibling donors.

Detailed description: Allogeneic Peripheral Blood Stem Cell Transplantation for Patients with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia in First Remission or Chronic Myelogenous Leukemia in First Chronic Phase

Eligibility: Inclusion Criteria:1. Any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: Specific disease categories include:
  1. acute myelogenous leukemia, 1st or 2nd remission
  2. acute lymphoblastic leukemia, 1st or 2nd remission
  3. chronic myelogenous leukemia, 1st or 2nd CP, accelerated phase 2. Patient age > 1 month and < 55 yo 3. Patients must have a genotypically HLA identical sibling 4. Patient must have adequate function as follows:
  a. total bilirubin <2.5 and SGOT/SGPT <2x normal b. adequate renal function as defined by creatinine < 1.5 or a 24 hr creatinine clearance >50 cc/min as determined by the Cockroft-Gault formula (to be done if serum creatinine > 1.5) c. DLCO > 60% predicted d. radionuclide cardiac scan with ejection fraction >45% 5. Patient must be competent to give consent.
  Inclusion criteria (Donor):
  1. HLA identical family member
  2. Donor or guardian must be competent to give consent
  3. Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter
  Exclusion Criteria:3.2 Exclusion Criteria (Patient):
  1. Evidence of active infection or active hepatitis
  2. Positive serologies for HIV-1,HIV-2 or hepatitis B surface ag+
  3. Previous allogeneic stem cell/bone marrow transplant
  4. Pregnant or lactating patients
  4 Exclusion criteria (Donor):
  1. Donors who for psychologic, physiologic or medical reasons are unable to tolerate PBSC harvest
  2. Donors who are HIV+ or hepatitis B antigen +
  3. History of allergic reaction to G-CSF
  4. Female donors must be post-menopausal or have a negative pregnancy test

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

Clinical trial: Natural Killer (NK) Cell Transplantation for AML

Summary: The purpose of this study is to assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse.

Detailed description: Natural killer (NK) cells extracted from a [parental] donor are infused intravenously. Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion. The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant.
  Details of Treatment Plan:
  Stratum 1 (AML in complete remission)
  Cyclophosphamide 60 mg/kg IV Day -7 Fludarabine 25 mg/m2/day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1, then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
  Stratum 2 (AML that is refractory or relapsed or AML with increasing minimal residual disease)
  Clofarabine 40 mg/m2 IV, days -6 through -2 Etoposide 100 mg/m2 IV, days -6 through -2 Cyclophosphamide 400 mg/m2 IV, days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1, and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0.
  For patients who have received prior SCT, the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor.
  Cytokine regimen (stratum 1 and 2): 1 million units/m2 of IL-2 given subcutaneously three times per week for two weeks (6 doses) starting on the evening of day -1.
  NK Cell Transplantation (stratum 1 and 2): NK cells from haplo-identical family donor will be infused on day 0.

Eligibility: Inclusion Criteria:
  -  Participants with AML that is in complete remission, is relapsed or refractory, or with increasing minimal residual disease.
  -  Participants in complete remission must have recovered from toxicity of previous therapy and have evidence of bone marrow recovery
  -  Participants who had prior stem cell transplant (SCT) must have no evidence of GVHD and 60 or more days have elapsed since the SCT.
  Exclusion Criteria:
  -  Participants who are pregnant
  -  Participants with inadequate renal, liver, or pulmonary functions

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

Clinical trial: A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

Summary: Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description: Purpose:
  Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.
  Phase II: Determine the complete remission rate (CR+CRp)

Eligibility: Inclusion Criteria:
  1. Morphologic evidence of acute myeloid leukemia in first relapse.
  2. Phase I: 18 years or older, Phase II: 50 years or older
  Exclusion Criteria:
  1. Prior treatment with zosuquidar
  2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
  3. History of stem cell transplant

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

Clinical trial: Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Summary: RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients receiving chemotherapy for acute leukemia.
  PURPOSE: This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.

Detailed description: OBJECTIVES:
  -  Determine the feasibility of conducting a randomized controlled trial, in terms of recruiting and retaining participants, to a study of healing touch (HT) as supportive care in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
  -  Examine potential barriers to participation and ascertain reasons for study drop-outs in these patients.
  -  Demonstrate whether these patients will comply with treatment sessions and remain in the study.
  -  Obtain preliminary data on the effectiveness of HT on psychological distress and treatment-related symptoms focusing on fatigue and sleep disturbances in these patients.
  -  Determine if the HT protocol needs to be refined, modified, or eliminated, based on pilot participant feedback, for a randomized clinical trial.
  OUTLINE: This is a pilot study.
  Within 1 week of admission to the hospital, patients are interviewed by a research assistant about previous use of complementary or alternative medicine therapies, knowledge of healing touch (HT), previous experience with HT, willingness to participate in a study of HT for acute leukemia patients, and willingness to be randomized in a HT study. The first 12 patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a week during weeks 2, 3, and 4 of induction or reinduction chemotherapy. Patients are also asked to rate current distress, pain, fatigue, and nausea before and after the second HT session during weeks 2, 3, and 4. Patients also complete self-report questionnaires at baseline, during week 5 of induction or reinduction chemotherapy or prior to discharge from the hospital, and during the first week of consolidation chemotherapy (approximately week 9-13).
  PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following acute leukemias:
  -  Acute lymphocytic leukemia
  -  Acute myeloid leukemia
  -  Hospitalized for induction (newly diagnosed patients) or reinduction (relapsed patients) chemotherapy
  -  Must be oncology inpatients at Wake Forest University Baptist Medical Center
  PATIENT CHARACTERISTICS:
  -  Must know adequate English to understand the consent form, complete questionnaires, and converse with study staff
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.

Summary: The purpose of this study is to evaluate the effectiveness (response rate) and safety of tipifarnib in patients with refractory or relapsed AML.

Detailed description: Acute myeloid leukemia (AML) accounts for approximately 25% of all cases of leukemia diagnosed in the Western hemisphere. First-line chemotherapy regimens induce complete remissions in 55-75% of patients. However, between 50% and 70% of patients who achieve remission will relapse. Current therapy for patients refractory to initial therapy or who relapse within 6 months of remission is unsatisfactory because complete remission rates are low and remission duration is brief. New drugs with novel mechanisms of action may be more beneficial than the currently available ones. Tipifarnib represents a new class of oncology drugs which have a specific cellular target (inhibition of the farnesyl transferase protein), one of the components of the Ras oncogene, as its specific mechanism of acton. It is believed that inhibition of this protein will lead to a decrease of cellular proliferation or cell death. This is an open-label, multicenter, non-comparative phase 2 study investigating the efficacy and safety of farnesyl transferase inhibition with tipifarnib administered orally as a single agent, twice daily, for the first 21 days of every 28 day cycle. Patients are enrolled by disease status into two cohorts; Cohort 1 includes patients with relapsed AML and Cohort 2, patients with refractory AML. All patients will be treated for a sufficient length of time to determine response to study medication (effectiveness) by evaluating the rate of complete remission (CR) or complete remission with incomplete platelet recovery (CRp), duration of complete remission, time to disease progression and progression-free survival, overall survival, and to characterize clinical benefit and quality of life (QOL). The safety profile of tipifarnib will also be determined in patients with refractory of relapsed AML.. The patients will receive six tablets (100 mg each) of tipifarnib twice daily for 21 of 28 day cycles (7 day rest period between cycles). Patients may receive tipifarnib until disease progression or unacceptable toxicity occurs.

Eligibility: Inclusion Criteria:
  -  Refractory or relapsed Acute myeloid leukemia (AML)
  -  Eastern Cooperative Oncology Group (ECOG) performance of 0-2
  -  any value of WBC
  -  able to eat food and medication orally
  -  females must use contraception and not be pregnant
  Exclusion Criteria:
  -  .Not in another study with an investigational agent within 3 weeks of tipifarnib administration
  -  must not have active CNS leukemia
  -  must not have disseminated intravascular coagulation (DIC) disorder with evidence of hemorrhage
  -  must not be allergic to imidazole drugs such as ketoconazole, miconazole, econazole, or terconazole.

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

Clinical trial: Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

Summary: Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.


Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of acute myeloid leukemia
  -  Recent bone marrow biopsy
  -  Prior treatment or medically unfit for standard therapy
  Exclusion Criteria:
  -  Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML
  -  Previous solid organ transplant
  -  Active GvHD or immunosuppression
  -  Concurrent treatment with other anti-cancer therapy
  -  Active infections

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

Clinical trial: NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

Summary: The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy.
  Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.

Detailed description: The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:
  1.1 Therapeutic aims
  To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.
  To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.
  To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).
  To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.
  1.2 Biologic aims
  To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.
  To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.
  To secure storage of biological material from diagnosis for future biologic studies

Eligibility: Inclusion Criteria:
  -  AML as defined by the diagnostic criteria,
  -  Age < 19 years at time of study entry,
  -  Written informed consent
  Exclusion Criteria:
  -  Previous chemo- or radiotherapy,
  -  AML secondary to previous bone marrow failure syndrome,
  -  Down syndrome (DS),
  -  Acute promyelocytic leukemia (APL),
  -  Juvenile myelomonocytic leukemia (JMML),
  -  Myelodysplastic syndrome (MDS),
  -  Fanconi anemia,
  -  Positive pregnancy test

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

Clinical trial: Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

Summary: The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.


Eligibility: Inclusion Criteria:
  -  Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
  -  ECOG performance status 0 to 2
  Exclusion Criteria:
  -  Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
  -  Allogenic transplantation within 6 months prior to inclusion
  -  Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
  -  Previous treatment with AVE9633
  -  Poor kidney, liver and bone marrow functions
  -  Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
  -  Pregnant or breast-feeding women
  -  Patient with reproductive potential without effective birth control methods
  The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Clinical trial: Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant

Summary: RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.
  PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.

Detailed description: OBJECTIVES:
  Primary
  -  To ascertain the safety of donor natural killer (NK) cells, generated from peripheral blood hematopoietic stem cells, when given as a single intravenous infusion in patients who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
  -  To determine the maximum tolerated dose of donor NK cells when given as a single infusion.
  Secondary
  -  To determine the effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor BMT.
  OUTLINE: Patients receive donor natural killer cells as a single infusion over 1 hour.
  Cohorts of 3-6 patients receive escalating doses of natural killer cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience grade III toxicities or acute graft-vs-host disease.

Eligibility: DISEASE CHARACTERISTICS:
  -  Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
  -  No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 70-100%
  -  Bilirubin < 2.0 mg/dL
  -  AST < 3 times upper limit of normal
  -  Creatinine < 2.0 mg/dL
  -  Ejection fraction > 40% on MUGA scan
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Allogenic Stem Cell Transplantation for Children, Adolescents and Young Adults With Relapsed or Refractory AML

Summary: 1. To evaluate whether stem cell transplantation from a matched sibling donor is equivalent to a matched unrelated donor in in a second complete remission of acute myeloid leukemia (AML).
  2. To evaluate whether stem cell transplantation (SCT) after chemotherapy (FLAMSA-schema) increases survival compared to a threshold derived from historical data
  3. To evaluate whether SCT from haploidentical donors for children having no matched donor will result in better survival with acceptable toxicity.

Detailed description: Target variables:
  -  Treatment response
  -  Event Free Survival
  -  Leukemia Free Survival
  -  Graft Versus Host Disease
  -  Regimen related toxicity

Eligibility: Inclusion Criteria:
  -  Aged between 0-21 years
  -  Patients suffering from either refractory de novo AML or relapsed AML or patients with very high risk AML in CR1
  -  In sexually active patients two reliable contraception methods are used. This includes every combination of a hormonal contraceptive (such as injection, transdermal patch, implant, cervical ring) or of an intrauterine device(IUD) with a barrier method (e.g. diaphragm, cervical cap, or condom) or with a spermicide.
  -  Written informed consent of patient, parents or legal guardians
  Exclusion Criteria:
  -  Severe renal impairment (GFR < 30% predicted for age)
  -  Pregnant or lactating females
  -  Current participation in another clinical trial
  -  Patients ≥ 12 years old for Group 1 ("BuCyMel") (patients younger that 12 years continue to be included)

Relevance to patient case: not relevant