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

Clinical trial: Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
  PURPOSE: Phase I trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or myelodysplastic syndrome.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of dolastatin 10 in patients with chronic myelogenous leukemia in blast phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes. II. Assess the possible antileukemia effect of this treatment in these patients.
  OUTLINE: This is a dose escalation study. Patients receive dolastatin 10 intravenous (IV) bolus once every 3 weeks. Patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first cohort of 3 patients, subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10. If DLT occurs in 2 of 3 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are followed until death.
  PROJECTED ACCRUAL: This study will accrue up to 25 patients within 8 months.

Eligibility: DISEASE CHARACTERISTICS: Histologically diagnosed chronic myelogenous leukemia in blastic phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes (refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia)
  PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered (unless evidence of rapid disease progression) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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

Clinical trial: Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

Detailed description: OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.
  OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases
  PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

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

Clinical trial: Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.
  PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).
  -  Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.
  OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.
  Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.

Eligibility: DISEASE CHARACTERISTICS:
  -  Prior registration on protocol CALGB-9665
  -  Diagnosed with acute myeloid leukemia (AML)
  -  Treated on a CALGB AML treatment protocol
  -  Diagnostic bone marrow or blood specimen available
  PATIENT CHARACTERISTICS:
  Age:
  -  15 and over

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

Clinical trial: Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

Summary: RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation.
  PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia.
  -  Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.
  OUTLINE: This is a pilot study.
  -  Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7.
  Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection.
  -  Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover.
  Patients are followed weekly until day 100 and then at days 180 and 360.
  PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of a malignant hematologic disease, including:
  -  Acute or chronic leukemia
  -  Myelodysplastic syndromes
  -  Myeloproliferative disorder
  -  Hodgkin's lymphoma
  -  Non-Hodgkin's lymphoma OR
  -  Aplastic anemia
  -  Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol
  -  HLA-matched (6/6) related donor available
  PATIENT CHARACTERISTICS:
  Age
  -  5 to 60
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients and donors must use effective contraception
  -  No known allergy to GM-CSF
  -  No prior of adverse reaction to any yeast recombinant molecule
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  See Disease Characteristics
  -  No prior allogeneic stem cell transplantation
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

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

Clinical trial: Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML)

Summary: The purpose of the study is to determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed acute myeloid leukemia (AML) who achieve a second complete remission (CR).

Detailed description: Patients randomly assigned to chemotherapy alone received the second course of induction chemotherapy as soon as clinically indicated; patients randomly assigned to receive chemotherapy plus sequential lestaurtinib had lestaurtinib withheld for 3 days (72 hours) before the start of the second 5-day course of chemotherapy and resumed lestaurtinib treatment 2 days (48 hours) after the final administration of the second course of chemotherapy.

Eligibility: Inclusion criteria:
  -  cytological confirmation of AML;
  -  relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days;
  -  confirmation of FLT-3 activating mutation positive status after point of initial relapse;
  -  aged 18 years or older;
  -  written informed consent;
  -  ability to understand and comply with study restrictions;
  -  no comorbid conditions that would limit life expectancy to less than 3 months;
  -  ECOG Performance Score of 0, 1,or 2;
  -  women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
  Exclusion criteria:
  -  bilirubin > 2x ULN;
  -  ALT/AST > 3x ULN;
  -  serum creatinine > 1.5 mg/dL;
  -  resting ejection fraction of left ventricle l < 45%(applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC];
  -  untreated or progressive infection;
  -  any physical or psychiatric cdtn that may compromise participation in the study;
  -  known CNS involvement with AML;
  -  any previous treatment with a FLT-3 inhibitor;
  -  requires current treatment for HIV with protease inhibitors;
  -  active GI ulceration or bleeding;
  -  use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment

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

Clinical trial: Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate

Summary: The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.


Eligibility: Inclusion Criteria:
  -  Subjects with myeloid blast phase chronic myeloid leukemia
  -  Subjects who are either resistant or intolerant of imatinib mesylate
  Exclusion Criteria:
  -  Subjects who are eligible and willing to undergo transplantation
  -  Serious uncontrolled medical disorder or active infection
  -  Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
  -  Subjects receiving medications that may affect heart rhythm
  -  Other malignancy/cancer other than CML
  -  History of significant bleeding disorder unrelated to CML
  -  Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
  -  Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
  -  Subject is receiving medications that affect platelet function or an anticoagulant

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

Clinical trial: Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

Summary: Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description: Purpose:
  Phase I:
  To Evaluate the safety of different doses of zosuquidar.
  Phase II:
  This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Eligibility: Inclusion Criteria:
  -  Newly diagnosed acute myeloid leukemia
  -  Ages 55-75 years
  Exclusion Criteria:
  -  Acute promyelocytic leukemia (FAB M3)
  -  Patients must not have received prior chemotherapy for AML.
  -  Prior exposure to anthracycline
  -  Use of any investigational agent within 4 weeks prior to enrollment into the study
  For Phase II:
  -  Patients must be P-glycoprotein positive

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

Clinical trial: Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Summary: The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

Detailed description: We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Eligibility: Inclusion Criteria:
  -  Age: 0 to 18 years
  -  Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts > 20 %)
  -  Isolated myeloid sarcoma
  -  Achieved complete remission
  -  No HLA identical family donor, except for the patients with t(8;21)
  -  No contraindication for the use of interleukin-2
  Exclusion Criteria:
  -  Trisomy 21
  -  Promyelocytic leukemia (M3) or M3 variations
  -  Secondary AML

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

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

Clinical trial: Trial of Decitabine in Patients With Acute Myeloid Leukemia

Summary: The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.


Eligibility: Inclusion Criteria:
  1. Must have diagnosed acute myeloid leukemia.
  2. Must have a life expectancy of at least 12 weeks.
  3. Must sign informed consent.
  Exclusion Criteria:
  1. Must not have acute promyelocytic leukemia (M3 classification)
  2. Must not have any other active systemic malignancies.
  3. Must not have inaspirable bone marrow.
  4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
  5. Must not have chronic respiratory disease that requires continuous oxygen use.
  6. Must not have received any experimental drug within 4 weeks before randomization.
  7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
  8. Must not have known HIV.

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

Clinical trial: Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Summary: The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.


Eligibility: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or intolerance to imatinib.
  -  Ph-negative acute leukemia in second or subsequent relapse
  -  Age >1 and <21 years
  -  Lansky or Karnofsky scale >60
  -  Life expectancy >3 weeks
  -  Adequate hepatic and renal function
  -  Written informed consent
  Exclusion Criteria:
  -  Subjects for whom potentially-curative therapy was available, including electing immediate [ie, planned <45 days] stem-cell transplantation. Subjects in Stratum 1 were to have had an ongoing identical HLA donor search, and may have discontinued study if a donor became available.)
  -  Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due to their CNS disease).
  -  Subjects who had not recovered from acute toxicity of previous therapy.
  -  Clinically-significant disorder of platelet function (eg, von Willebrand's disease) or ongoing gastrointestinal bleeding.
  -  Serious uncontrolled medical disorder or active infection
  -  Uncontrolled or significant cardiovascular disease
  -  Use of any investigational agent or any other anticancer agent within 14 days prior to treatment start.
  -  Prior therapy with dasatinib
  -  Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
  -  Subjects taking certain medications that are accepted to have a risk of causing QTc prolongation.
  -  Women of Child Bearing Potential with a positive pregnancy test prior to study drug administration.
  -  Expected noncompliance, or unable to have regular follow-up due to psychologic, social, familial, or geographic reasons.
  -  Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study.

Relevance to patient case: not relevant