araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.

Summary: Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.
  The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.


Eligibility: Inclusion Criteria:
  -  NOTE: the following eligibility criteria were applicable to acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
  -  ALL with > 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and AML patients may have extramedullary disease
  -  Karnofsky Performance Status ≥ 50 for patients > 10 years old; Lansky Performance Status ≥ 50 for patients ≤ 10 years old
  -  Prior therapy: AML: 1-2 prior induction regimens and ≤ 1 hematopoietic stem cell transplant (HSCT); ALL: 1-3 prior induction regimens
  -  Adequate liver, renal, pancreatic, and cardiac function
  -  Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
  Exclusion Criteria:
  -  NOTE: the following eligibility criteria were applicable to ALL and AML patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
  -  Burkitt's leukemia
  -  Previous treatment with clofarabine
  -  Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood cultures required for patients with a history of fever within 3 days of enrollment
  -  Active CNS involvement (i.e., should be CNS1 or CNS2)
  -  Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7 days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy
  -  Have received prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
  -  Pregnant or lactating
  -  Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

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: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Study of XL999 in Patients With Acute Myeloid Leukemia (AML)

Summary: This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.


Eligibility: Inclusion Criteria:
  -  Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia [APL]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
  -  ECOG performance status of 0 or 1
  -  Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
  -  Adequate liver and renal function
  -  Signed informed consent
  Exclusion Criteria:
  -  Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
  -  Hematopoietic stem cell transplantation within the previous 6 weeks
  -  Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
  -  The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
  -  Uncontrolled and/or concomitant illness
  -  Pregnant or breastfeeding females
  -  Known HIV

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
  PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the complete remission rate (CR).
  -  Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
  -  Further evaluate the toxicity of this regimen.
  OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Eligibility: DISEASE CHARACTERISTICS:
  Inclusion criteria:
  -  Newly diagnosed acute myeloid leukemia (AML)
  -  Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
  -  FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
  -  Previously untreated with radiotherapy or chemotherapy
  -  Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
  -  Patients with prior myelodysplastic syndrome are eligible
  -  Extramedullary leukemia allowed
  -  AML with lymphoid markers allowed
  Exclusion criteria:
  -  Blastic transformation of chronic myelogenous leukemia
  -  Biphenotypic leukemia
  -  FAB M3 disease (acute promyelocytic leukemia)
  PATIENT CHARACTERISTICS:
  -  Life expectancy ≥ 6 weeks
  -  Total bilirubin < 1.5 g/dL
  -  AST and ALT < 5 times upper limit of normal (ULN)
  -  Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
  -  Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
  -  HIV antibody-negative
  PRIOR CONCURRENT THERAPY:
  Inclusion criteria:
  -  See Disease Characteristics
  -  Prior hydroxyurea or corticosteroids allowed
  -  At least 48 hours since prior and no concurrent itraconazole or fluconazole
  Exclusion criteria:
  -  More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors

Summary: This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.


Eligibility: Inclusion Criteria:
  -  Solid tumors that have failed auto transplant or are ineligible to receive auto transplant
  -  Relapsed AML in 1st relapse or 2nd or 3rd CR
  -  Relapsed ALL if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy.
  -  Greater than or equal to 6 months and <26 years old
  -  Suitable haploidentical donor available
  Exclusion Criteria:
  -  Leukemia with >25% blasts in bone marrow at the time of admission to the HSCT unit.
  -  Serum bilirubin >3 mg/dl
  -  GFR <40 ml/min/1.73 mw
  -  Cardiac left ventricular ejection fraction <40%
  -  HIV+
  -  Pregnant

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

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
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

Summary: This study will see if the researchers can lower that risk by giving the patient Palifermin. This drug helps protect the lining of the mouth, throat, and stomach. These areas typically get sores or ulcers while the blood cell counts are very low. The patient can get infections in or from these sores. Palifermin might also help the immune system recover faster. It is currently approved for patients who receive their own stem cells. That is called an autologous transplant. This study will test the use of Palifermin for T-cell depleted allogeneic stem cell transplants.


Eligibility: Inclusion Criteria:
  -  Patients should be < 65 years. Patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the BMT Service.
  -  Patients may be of either gender or any ethnic background.
  -  Patients must have a Karnofsky or Lansky Performance Status > or equal to 70%.
  -  Patients must have adequate organ function measured by:
  * Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > or equal to 50% and must improve with exercise.
  -  Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
  -  Renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 60-ml/min/1.73 m2
  -  Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)
  -  Each patient must be willing to participate as a research subject and must sign an informed consent form.
  -  Parent or legal guardians of patients who are minors will sign the informed consent form.
  Exclusion Criteria:
  -  Active CNS or skin leukemic involvement
  -  Female patients who are pregnant or breast-feeding
  -  Active viral, bacterial or fungal infection
  -  Patient seropositive for HIV-I/II; HTLV -I/II
  -  Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
  -  Patients who have had a previous malignancy that is not in remission.

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Reduction of Cord Blood Transplantation Toxicity in Patients With Acute Myeloid Leukemia

Summary: Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.

Detailed description: Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.

Eligibility: Inclusion Criteria:
  -  Ages : 4 to 65
  -  De novo or secondary AML requiring allogeneic transplant
  -  No donor (related or unrelated) compatible 10/10
  -  Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17)
  -  Smouldering AML without progression
  -  Signed assent of recipient
  Exclusion Criteria:
  -  If CR1: AML with with t(8;21) or inv (16) or t (15;17)
  -  Karnofsky < 50% - Clearance of creatinin < 40 ml/min
  -  Transaminases > 8 N
  -  Previous autologous or allogeneic transplantation within 6 month prior to the study (except if tandem)
  -  total body irradiation contra-indicating 2 Gy TBI
  -  local irradiation contra-indicating 2 Gy TBI

Relevance to patient case: not relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Summary: The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Detailed description: A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
  However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Eligibility: Inclusion Criteria:
  -  Patients ages between 0 to and 65 years of age.
  -  Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
  -  Acute lymphocytic leukemia (ALL) in CR1 with high risk features
  -  Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
  i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
  -  Acute Leukemias in 2nd or greater remission
  -  Refractory or Relapsed AML
  -  AML transformed from MDS
  -  Myelodysplastic syndrome (MDS) beyond refractory anemia
  -  Chronic myeloid leukemia (CML)
  -  Chronic myelomonocytic leukemia
  -  Philadelphia-negative myeloproliferative disorder
  -  Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
  -  Multiple Myeloma-Stage III
  Exclusion Criteria:
  -  Prior autologous or allogeneic stem cell transplant.
  -  Performance status greater than 2
  -  Active infection.
  -  Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
  -  Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
  -  Inadequate Serum creatinine clearance <60
  -  InadequatebHepatic function
  -  Positive serology for HIV-1, 2 or HTLV-1, 2.
  -  Pregnancy. Female patient must have negative pregnancy test

Relevance to patient case: definitely relevant
Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

Summary: This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients <18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.


Eligibility: Inclusion Criteria:
  -  Mixed-lineage leukemia (MLL) gene rearranged Acute Lymphoblastic Leukemia (ALL), that does not respond to treatment or has relapsed from prior treatment; or FLT3 mutated Acute Myeloid Leukemia (AML) that does not respond to a second treatment or has relapsed from 2 prior treatments
  -  Normal organ function, and chest x-ray
  -  Expected survival greater than 8 weeks
  -  Can care for most of personal needs and perform at least minimum activity
  Exclusion Criteria:
  -  Patients with symptomatic leukemic central nervous system involvement or isolated extramedullary leukemia
  -  Patients must not have received other treatments for leukemia within a predefined time period, 72 hours for medications, 2 months for transplants
  -  Patients with heart function that is not normal
  -  Patients with HIV or hepatitis
  -  Patients with another severe disease or medical condition besides leukemia Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant