araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity

Summary: A sample of 60 children is randomly assigned to an intervention and a control condition. The intervention group receives 15 sessions of child-focused treatment with play training to enhance play persistence and intensity. The control group receives the same amount of placebo play sessions. The intervention group receives subsequently 15 sessions of parent training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in the intervention than in the control group. Play-persistence and -intensity should also increase more in the intervention group. An additional effect of a subsequent parent training shall furthermore be tested.


Eligibility: Inclusion Criteria: Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions
  Exclusion Criteria: Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

Summary: The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.


Eligibility: Inclusion Criteria:
  -  Subjects must have relapsed or primary refractory non-M3 acute myeloid leukemia or relapsed or refractory non-T-cell acute lymphoblastic leukemia or untreated acute myeloid leukemia in elderly patients.
  -  Performance status of 0, 1 or 2 per WHO classification.
  -  Adequate renal and liver function.
  -  Adequate blood creatine kinase value (CK < 1.5ULN)
  Exclusion Criteria:
  -  Allogeneic stem cell transplantation within the last 4 months and/or active graft versus host disease requiring systemic immunosuppressant therapy, or autologous stem cell transplantation within the last 4 weeks.
  -  Patient for which immediate allogeneic stem cell transplantation is the treatment of choice.
  -  Pregnant or nursing (lactating) women.
  -  Active CNS leukemic involvement

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

Summary: To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).


Eligibility: Inclusion Criteria:
  -  Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
  -  Karnofsky or Lansky ≥ 50
  -  Adequate renal, hepatic and pancreatic function
  -  Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
  -  Written informed consent
  Exclusion Criteria:
  -  Treatment with strong CYP3A4 inhibitors or inducers
  -  Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
  -  Acute or chronic liver, pancreatic or severe renal disease
  -  History of pancreatitis or chronic pancreatitis.
  -  Impaired cardiac function
  -  No evidence of active graft vs host and <3mo since Stem Cell Transplant
  -  Total body irradiation (TBI) or craniospinal radiation therapy <6months
  -  Hypersensitivity to the active ingredient or any of the excipients including lactose.
  -  Other protocol-defined inclusion/exclusion criteria.

Relevance to patient case: definitely relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

Summary: This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.

Detailed description: PRIMARY OBJECTIVES:
  I: To determine the feasibility of obtaining standardized phase angle measurements (bioelectrical impedance measurement) on patients hospitalized for treatment of newly diagnosed acute leukemia.
  II. To evaluate the association between standardized phase angle measured at the start of therapy and treatment-related outcomes including treatment related mortality (defined as 60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and treatment related outcomes, 30-day mortality, length of hospitalization, transfer to intensive care unit during induction, treatment response (14 day bone marrow response, complete remission), receipt of post-remission therapy, overall survival.
  IV. An exploratory analysis investigating associations with the primary and secondary outcomes using different ways to categorize the baseline standardized phase angle and, for acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just prior to the nadir marrow.
  OUTLINE:
  Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, peripherally inserted central catheter [PICC] line placement, etc.).
  After completion of study treatment, patients are followed up for two years.

Eligibility: Inclusion Criteria:
  -  Hospitalized for newly diagnosed acute leukemia
  -  Receiving induction treatment while hospitalized
  -  Willing and able to provide written informed consent
  Exclusion Criteria:
  -  Presence of a pacemaker or defibrillator
  -  Patients pregnant at the time of enrollment
  -  Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  -  Unable/unwilling to follow protocol requirements

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: TKI Therapy Based on Molecular Monitoring in Allogeneic-HSCT Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Summary: The purpose of this study is to evaluate the efficacy of tyrosine kinase inhibitor(TKI) therapy based on molecular monitoring of BCR/ABL levels in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)undergoing allogeneic hematopoietic stem cell transplantation(allo-HSCT).

Detailed description: Philadelphia chromosome (Ph) is a reciprocal chromosomal translocation t(9;22）(q34;q11), which leads to the formation of the BCR/ABL oncogene. Ph is the most frequent cytogenetic abnormality in ALL characterized by poor outcome. With the BCR/ABL protein TKI, imatinib, in the combination chemotherapy regimes for newly diagnosed Ph+ ALL, more than 95% of patients can achieve complete remission(CR)1. Several studies have shown decreased relapse rates and improved disease-free survival for patients with imatinib-based treatment prior to allo-HSCT. However, the efficacy of maintenance therapy with imatinib after transplant for Ph+ ALL patients is still uncertain. In addition, acquired resistance to imatinib is frequently caused by point mutations in BCR/ABL that inactivate imatinib.
  Detection of minimal residual disease (MRD) after transplant is associated with an increased risk of relapse. Reverse transcription-polymerase chain reaction (RT-PCR) is a sensitive method for detecting low-level BCR/ABL transcripts to assess MRD in Ph+ ALL. It has been corroborated by several reports that detection of MRD after SCT was predictive of imminent relapse.
  In this study, we will evaluate the safety and efficacy of TKI therapy, when initiating treatment based on BCR-ABL transcript levels after allo-HSCT.

Eligibility: Inclusion Criteria:
  -  A patient age of 14-65 years
  -  Allo-HSCT recipient with ph+ ALL
  -  Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  Exclusion Criteria:
  -  Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
  -  patients with hematological relapse, extramedullary involvement of leukemia
  -  Patients with any conditions not suitable for the trial (investigators' decision)

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention

Summary: This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.

Detailed description: Study Design This is a prospective randomized trial to determine the effectiveness of different doses of GVHD prophylaxis on mucositis, engraftment and aGVHD. Study consists of two study groups of 50 subjects each.
  Group A will receive Tac and MTX (15 mg/m2 day +1, 10 mg/m2 day +3, +6, +11). Group B will receive Tac, Mini-dose MTX (5 mg/m2 on day +1, +3, +6) and MMF.

Eligibility: Inclusion Criteria:
  -  Patients must have one of the following documented diseases:
  -  Chronic myelogenous leukemia
  -  Chronic lymphocytic leukemia
  -  Multiple myeloma
  -  Myelodysplasia
  -  Myeloproliferative disorder
  -  Non-Hodgkin's lymphoma
  -  Hodgkin's disease
  -  Acute myelogenous leukemia
  -  Acute lymphoblastic leukemia
  -  Acute biphenotypic leukemia
  -  Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:
  -  Busulfan (≥ 12.8 mg/kg IV or PO) and cyclophosphamide (≥ 120 mg/kg)
  -  Total body irradiation (TBI) (≥ 1200 cGy) and etoposide (60 mg/kg)
  -  TBI (≥ 1200 cGy) and cyclophosphamide (120 mg/kg)
  -  Patient must have achieved and be in complete morphologic remission prior to starting conditioning regimen
  -  Patient's donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
  -  Adult patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; pediatric patients must have Lansky score ≥ 60%
  -  Patients must have a life expectancy of 100 days
  -  Patients must sign written informed consent
  Exclusion Criteria:
  -  Patients who have undergone any prior transplant
  -  Patients who are seropositive for human immunodeficiency virus (HIV)
  -  Patients with any medical illness or concurrent psychiatric illness which, in the investigators' opinion, cannot be adequately controlled with appropriate therapy
  -  Patients who are pregnant or lactating

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT

Summary: molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.
  Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.
  the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)


Eligibility: Inclusion Criteria:
  -  high risk t (8; 21) AML
  -  molecular relapse after allo-SCT
  Exclusion Criteria:
  -  active graft-versus-host disease
  -  uncontrolled severe infection
  -  organ function failure

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia

Summary: The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in improving the response to imatinib in CML patients not achieving an optimal response with imatinib alone.

Detailed description: To improve cytogenetic and molecular response of CML patients receiving Imatinib, who have not achieved an optimal response according to European LeukemiaNet (ELN) definitions , or MR4 after 24 months with Imatinib. This will be achieved by addition of the CXCR4 antagonist BL-8040, mobilizing CML leukemia stem cells from their protective bone marrow niche and exposing them to Imatinib and BL-8040-mediated apoptosis.

Eligibility: Inclusion Criteria:
  1. Adult men and women subjects aged 18 to 70, inclusive.
  2. Confirmed diagnosis of chronic phase CML according to the WHO criteria (WHO 2008)
  3. CML patients with sub-optimal response to Tyrosine Kinase Inhibitors, defined as "warning" in the ELN recommendations:
  Following 3 months: BCR-ABL1 > 10%, and/or Ph+ 36-95% Following 6 months: BCR-ABL1 1-10%, and/or Ph + 1-35% Following 12 months: BCR-ABL1 0.1-1 % Following 24 months: Less than MR4
  4. Clinical laboratory values should be as follows:
  White blood cell count < 30 X 10*9/L Creatinine < 1.5 ULN
  5. Women of childbearing potential and all men must agree to use approved form of contraception
  6. Subject is able and willing to comply with the requirements of the protocol.
  7. Subject is able to voluntarily provide written informed consent.
  Exclusion Criteria:
  1. CML patients not in chronic phase.
  2. CML patients receiving Tyrosine Kinase Inhibitors other than Imatinib.
  3. CML patients receiving Imatinib > 400 mg/day.
  4. Patients not able to sign informed consent.
  5. Known allergy or hypersensitivity to any of the test compounds or materials or contraindication to test product.
  6. Low Performance Status (ECOG > 2).
  7. Abnormal liver function tests:
  1. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 2 x upper limit of normal (ULN).
  2. Serum bilirubin. Total bilirubin > 2.0 mg/dL (34 µmol/L), conjugated bilirubin > 0.8 mg/dL
  8. Abnormal left ventricular ejection fraction, < 40 %.
  9. Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
  1. Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy
  2. A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
  10. Women subjects who are pregnant or breastfeeding.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

Summary: The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.
  CD20* = cluster of differentiation antigen 20

Detailed description: The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
  -  Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
  -  Need for treatment is indicated (see 4.3 below)
  -  Age at least 18 years
  -  General state of health according to WHO 0-2
  -  Written declaration of consent by the patient
  -  Current histology, which should not be older than 6 months, is necessary
  Exclusion Criteria:
  -  Patients, who do not fulfil the above-mentioned inclusion criteria.
  -  Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min
  -  Patients with proven HIV infections
  -  Patients with active hepatitis
  -  Patients with other florid infections
  -  Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

Summary: The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).


Eligibility: Inclusion Criteria:
  -  Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
  -  Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
  -  Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
  Exclusion Criteria:
  -  Participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib.
  -  Prior treatment with bosutinib.
  -  Prior treatment with ponatinib.
  -  Known T315I or V299L mutation.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: The Impact of the Practice of Touch-massage on the Anxiety of Patients With Hematological Disorders Hospitalized in a Protective Environment, a Randomized, Controlled Study

Summary: Each year, 17000 cases of severe hematological diseases are diagnosed in France, with more than 6,000 of these requiring hospitalization in a protective, sterile environment. New methods, such as touch massage, have emerged in response to anxiety symptoms observed in patients in such sterile and isolated surroundings. We hypothesize that during the period of isolation, touch massage becomes a nursing care which can help the patient.

Detailed description: Patients with hematologic diseases (leukaemia, myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks 18 to 65 years female or male Not having met the nurse, who is providing the touch-massage

Eligibility: Inclusion Criteria:
  -  Patients with hematologic diseases (leukaemia, Myeloma, lymphoma) hospitalized in a sterile area of a hematology unit for at least 3 weeks
  -  18 to 65 years
  -  Female or male
  -  Not having met the nurse, who is providing the touch-massage
  Exclusion Criteria:
  -  Allergy to sweet almond oil
  -  Injury to the skin, at the back and / or arms and / or hands
  -  Cognitive impairment and / or preventing psychiatric responses to interviews and / or questionnaires
  -  Physical inability to take sitting in an ergonomic chair for the conduct of touch massage.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia

Summary: Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.


Eligibility: Inclusion Criteria:
  -  Young adult (18-30 years) Leukemia survivor, in first complete remission (lasting already for at least 24 months for acute grafted leukemia patients or 48 months for ungrafted acute leukemia patients).
  -  Acute leukemia diagnosed since January 1980 .
  -  Patient Affiliated to social security or beneficiary
  -  Signed Informed Consent prior to any screening procedures
  Exclusion Criteria:
  -  Emergency
  -  Patient unable to abide by the study protocol (for geographical, social or psychological reasons)

Relevance to patient case: not relevant