Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and...
Acute Lymphoblastic LeukemiaThe purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
Acute Lymphocytic LeukemiaDetermine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.
Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Acute Myeloblastic LeukemiaAcute Lymphoblastic Leukemia1 moreThe COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.
JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity...
Acute Lymphoblastic LeukemiaLymphoblastic LymphomaThis study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.
CTL019 Out of Specification MAP for ALL or DLBCL Patients
Acute Lymphoblastic Leukemia (ALL)Diffuse Large B-cell Lymphoma (DLBCL)Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.
Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in...
Acute Lymphoblastic LeukemiaB-Cell Non-Hodgkin Lymphoma6 moreThis research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.
Study of Biomarkers in DNA Samples From Patients With Acute Lymphoblastic Leukemia or Acute Myeloid...
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T17 moreThis research study is looking at biomarkers in DNA samples from patients with acute lymphoblastic leukemia or acute myeloid leukemia. Studying samples of DNA from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
Response or Resistance to Chemotherapy in Young Patients With Acute Lymphoblastic Leukemia Treated...
B-cell Childhood Acute Lymphoblastic LeukemiaChildhood Acute Lymphoblastic Leukemia in Remission2 moreThis laboratory study is looking at response or resistance to chemotherapy in young patients with acute lymphoblastic leukemia treated with methotrexate. Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and drug resistance in patients.
Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory...
Relapsed/Refractory B-Precursor Acute Lymphoblastic LeukemiaPrimary Objective: To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments Secondary Objective(s): To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT. Hypotheses: A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated. Study Endpoints: Incidence of treatment-emergent and treatment-related adverse events Incidence of CR within 2 cycles of blinatumomab MRD remission within 2 cycles of blinatumomab RFS OS Incidence of alloHSCT 100-day mortality after alloHSCT Study Design: Multi-center, open-label, single-arm expanded access protocol
Expanded Access Program of Ponatinib
Chronic Myeloid Leukemia (CML)Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.