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Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

Emerging results suggest that a cure rate of nearly 90 percent will be attained in the near future. The advance was attributed to stringent application of prognostic factors for risk factor-directed therapy. Early response to treatment has greater prognostic strength than does any other biologic or clinical feature tested to dates. The measurement of minimal residual disease(MRD) affords a level of sensitivity and specificity that cannot be attained through traditional microscopic morphologic assessments. In Taiwan, detection for the most recurrent fusion genes and the MRD were not commonly available, the TPOG(Taiwan Pediatric Oncology Group) used clinical features, immunophenotypes, and cytogenetics to do risk group classifications and protocol assignment. A successful rate of 60-70% has been reached. In order to improve the cure rate of ALL in Taiwan, this project aims at establishing the methods for better risk classifications and establishing MRD detection for risk-directed therapy for childhood ALL in Taiwan.Intrinsic and acquired resistances to multiple anticancer agents represent major obstacles and accounts for 10-20% of treatment failure in the developed countries nowadays. Recent progress using DNA microarray identified differential expression level of the genes known to implicate in cell cycle control, DNA repair and apoptosis in different subsets of ALL patients, which were found to be related to drug response. Genetic polymorphisms in the genes of drug-metabolizing enzymes, drug transporters or drug targets, can influence the efficacy or toxicity of antileukemic agents. Specific genotype might be important in determining the pharmacokinetic effects of one population or disease subtype from that in others. Recently, the expression profiles of relatively few microRNAs (miRNAs) (~200 genes), was noted to accurately classify human cancers. These informations hinted that expression of the genes in the leukemic cells might serve as additional risk factors for treatment stratification. Specific aims and goals: 1. to establish better risk factors classification and use MRD to monitor early response to treatment. 2. to establish the expression profiles of 12 genes associated with drug resistance 3. to unravel the pharmacogenetic background of pediatric ALL in Taiwan, so that will help refine the therapy dose, achieve a better drug effect and avoid acute or chronic toxicity. 4. microRNA expression profiles in childhood ALL in Taiwan

NCT00526084 — Leukemia, Lymphocytic, Acute
Status: Recruiting
http://inclinicaltrials.com/leukemia-lymphocytic-acute/NCT00526084/

Erwinase Study in Patients With Acute Lymphoblastic Leukemia

Erwinia L-Asparaginase (Erwinase) Study in Patients With Acute Lymphoblastic Leukemia

The goal of this clinical research study is to allow doctors to use Erwinia L-Asparaginase (Erwinase®) as a replacement for patients who are allergic to E.coli L-asparaginase or Pegylated E.coli L-asparaginase as part of the treatment for acute lymphoblastic leukemia (ALL) or T or B cell lymphoma. This trial was part of a multi institutional effort by the drug company to make Erwinase available for use.

NCT00506597 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT00506597/

Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia

A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-Leukemia Chemotherapy

This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original enrollment target for this study was approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65. The primary objective of this study was to evaluate: - The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.

NCT00495079 — Acute Lymphoblastic Leukemia (ALL)
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia-all/NCT00495079/

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.

NCT00494897 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00494897/

Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy. High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

NCT00483132 — Leukemia, Lymphocytic, Acute
Status: Completed
http://inclinicaltrials.com/leukemia-lymphocytic-acute/NCT00483132/

Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Classification Of Acute Lymphoblastic Leukemia

This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

NCT00482352 — Untreated Adult Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/untreated-adult-acute-lymphoblastic-leukemia/NCT00482352/

Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Multiple Myeloma Undergoing Donor Stem Cell Transplant

Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant

RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant. PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.

NCT00469820 — Leukemia
Status: Terminated
http://inclinicaltrials.com/leukemia/NCT00469820/

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia - LAL0904

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

NCT00458848 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT00458848/

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

A Study of Bortezomib With Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia

This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.

NCT00440726 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00440726/

Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia

A Study of Neurocognitive Function in Children Treated for ALL

This clinical trial is looking at brain function in young patients receiving methotrexate for acute lymphoblastic leukemia. Learning about the long-term effects of methotrexate on brain function may help doctors plan cancer treatment.

NCT00437060 — Long-Term Effects Secondary to Cancer Therapy in Children
Status: Completed
http://inclinicaltrials.com/long-term-effects-secondary-to-cancer-therapy-in-children/NCT00437060/