Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.
NCT01556386 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT01556386/
Trial protocol intended the optimization of induction treatment with: 1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation. 2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration 3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making. For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy. Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second. Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions
NCT01540812 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT01540812/
OBSERVATIONAL: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)
This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia
NCT01540578 — Recurrent Childhood Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/recurrent-childhood-acute-lymphoblastic-leukemia/NCT01540578/
Signaling in Tumorigenesis and Immunity
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.
NCT01520246 — Lymphoma
Status: Completed
http://inclinicaltrials.com/lymphoma/NCT01520246/
Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane. This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.
NCT01518517 — Acute Lymphoblastic Leukemia, in Relapse
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-in-relapse/NCT01518517/
Phase II Trial of CLAG-M in Relapsed ALL
CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.
NCT01513603 — Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT01513603/
Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol
Neuropathic pain / peripheral neuropathy (NP/PN) is a known painful complication of vincristine (VCR) therapy; evidence supporting the best treatment plan for pediatric patients is limited. Gabapentin is frequently used for VCR-related NP/PN, with variable dosing and scheduling regimens, and with varying measures of success. The hypothesis of the study is that gabapentin will reduce the severity of NP/PN in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated "as per TOTXVI protocol"), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily.
NCT01506453 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT01506453/
Micro RNA Expression Analysis in B-Lineage Adult Acute Lymphoblastic Leukemia From ALL Trial, E2993, Including Patients With Various Cytogenetic and Molecular Abnormalities
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with acute lymphoblastic leukemia enrolled on ECOG-2993 clinical trial.
NCT01505699 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT01505699/
A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (remission). Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
NCT01503632 — Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT01503632/
20-25% of patients over 15 years with acute lymphoblastic leukemia (ALL) have the Philadelphia chromosome or BCR-ABL rearrangement. Traditionally, intensive chemotherapy followed by hematopoietic stem cell transplantation (HSCT) have formed the basis allogeneic treatment of this disease, but the results have been poor (60-75% complete remissions-RC-and probability of long-term survival less than 20%). The effectiveness of imatinib for hematologic responses in patients with Ph + (observed in phase I and II) led to its use in phase III trials in combination with chemotherapy. They saw a chance of obtaining the RC above 90%, with acceptable toxicity, a molecular response rate (MR) of 40-50%, and prolonged follow-up studies, a probability of disease-free survival (DFS ) of 30-50%, significantly higher than historical controls with the same chemotherapy without imatinib. This led to the approval of imatinib by the rating agencies in the U.S., Europe and Japan as a treatment for Ph + in combination with chemotherapy. Of the studies that led to the approval of this indication for imatinib, and other incurred after, the following conclusions can be drawn: There is no specific pattern of combination of imatinib (at doses of 600 mg / day, po) and chemotherapy. However, when compared with concomitant alternating with the first achieved a higher rate of RM at the end of induction, although this did not influence DFS. In studies in elderly patients has achieved a high CR rate (almost 100% in all series), only imatinib and glucocorticoids, suggesting that an attenuated induction may be sufficient to achieve CR in young patients with minimal toxicity, which further compromises the administration of treatment and allow for an allogeneic HSCT with minimal toxic load possible. Although there is no consensus on the indication of allogeneic HSCT in first CR when given imatinib associated with intensive chemotherapy is an option that is done in most studies. The allogeneic HSCT is most effective when carried out in complete molecular response to or greater than when there is more residual disease. However, the impact of MRI to obtain early (after induction) on survival is not clear. So far-reaching goal is to make the TPH in complete molecular response situation or greater. The relapse of the disease at the molecular level is still short-term (less than 3 months) of hematological relapse. This implies the need for frequent monitoring of residual disease (ER) The frequency of relapse post HSCT is high (around 30%), raising the need for any post HSCT treatment, including imatinib included. Are currently ongoing clinical trials comparing the systematic administration of imatinib after administration TPH face is detected only when ER. The applicability of the administration of imatinib after HSCT is limited by toxicity related to the procedure of TPH, is making frequent dose reduction or discontinuation. Therefore, a reasonable approximation treatment of Ph + outside the context of a clinical trial is to get as many molecular responses before allogeneic HSCT in a position to make the same MRI complete or greater. After TPH, must be very close monitoring of the ER, and imatinib is administered as soon as you notice the loss of molecular response. In patients who can not make an allogeneic HSCT for lack of histocompatible donor or contraindications for its realization it is recommended imatinib and chemotherapy, although there are studies that have undergone an autologous HSCT, followed or not treatment "maintenance" with imatinib. The low toxicity of autologous HSCT and no effect of graft versus leukemia are strongly recommended the administration of maintenance therapy with imatinib combined with chemotherapy or not.
NCT01491763 — Acute Lymphoblastic Leukemia Ph Positive
Status: Recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-ph-positive/NCT01491763/