Gleevec (Imatinib) Plus Multi-Agent Chemotherapy For Newly-Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Imatinib mesylate may also stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which treatment regimen is most effective in treating acute lymphoblastic leukemia. PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate together with combination chemotherapy with or without a donor stem cell transplant and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.
NCT00618501 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT00618501/
AIEOP LLA 2000 Multicenter Study for the Diagnosis and Treatment of Childhood Acute Lymphoblastic Leukemia
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. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: Thisphase III trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.
NCT00613457 — Leukemia
Status: Completed
http://inclinicaltrials.com/leukemia/NCT00613457/
Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia
Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age. Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to current overall survival rates of approximately 80%.The high survival rates have introduced us to novel medical problems as a consequences of the different treatment regimens. No single treatment modality exists today but rather several treatment protocols are accepted worldwide. As such, the population of the childhood ALL survivors differ in their toxic exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone marrow transplantation .As the survival rates grow, there are more young adult ALL survivors worldwide susceptible to these late effects of treatment. Numerous reports have pointed out that this particular group is at increased risk to develop cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension, dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the general population. Adipocytokines, mediators secreted by adipose tissue, play an important role in the regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede the clinical symptoms. We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize the population at risk to develop DM and CVD prior to overt clinical disease. Characterization will be done by measuring serum adipocytokines and inflammatory cytokine profiles .Biochemical characterization of the group at risk will enable us to intervene in the preventive stage in the future.
NCT00566566 — Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/leukemia/NCT00566566/
An Intergroup Phase II Clinical Trial for Adolescents and Young Adults With Untreated Acute Lymphoblastic Leukemia (ALL)
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. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia.
NCT00558519 — Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/leukemia/NCT00558519/
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)
This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 — Acute Lymphoblastic Leukemia
Status: Active, not recruiting
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00557193/
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
The primary objective of this study (TOTXVI) is to compare the clinical benefit, the pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG) asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in conventional dose (CD PEG) during the continuation phase. This study has several secondary objectives: Therapeutic Objectives: To estimate the event-free survival and overall survival of children with ALL who are treated with risk-directed therapy. To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD > 5%, will result in improved leukemia cytoreduction in this subgroup compared to TOTXV. To assess whether intensification of central nervous system (CNS)-directed intrathecal and systemic chemotherapy will improve outcome in patients at high risk of CNS relapse. Exploratory Pharmacologic Objectives: To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors for treatment-related outcomes in the context of the systemic therapy used in the protocol. To compare the pharmacokinetics and pharmacodynamics of PEG-asparaginase given in higher dose (3,500 or 3,000 units/m2) versus those of PEG-asparaginase given in conventional dose (2,500 units/m2) in the continuation phase. Exploratory Biologic Objectives: To determine the prognostic value of levels of minimal residual disease in peripheral blood at day 8 of remission induction. To validate new markers and methods for MRD detection. To genotype natural killer (NK) cell receptors and measure their expressions at diagnosis and before reinduction, and to associate these features with treatment outcome. To identify new prognostic factors by applying new technologies to study patient material (e.g., stored plasma, serum, cerebrospinal fluid, and normal and leukemic cells). Exploratory Neuroimaging Objectives: To use quantitative MR measures (Diffusion Tensor Imaging and high resolution volumetric imaging) to assess differences in myelin and cortical thickness development in patients treated for ALL relative to healthy controls matched for age and gender. To assess the impact of folate pathway genetic polymorphisms on myelin and cortical thickness development and neurocognitive performance. To assess the impact of frontal-parietal lobe myelin and cortical thickness development on neurocognitive performance in attention, working memory, fluency, visual-spatial reasoning and processing speed.
NCT00549848 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00549848/
Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase
The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.
NCT00548431 — Leukemia, Lymphocytic, Acute
Status: Completed
http://inclinicaltrials.com/leukemia-lymphocytic-acute/NCT00548431/
Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase?; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)
This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
NCT00537030 — Childhood Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/childhood-acute-lymphoblastic-leukemia/NCT00537030/
LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%. Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation
NCT00526409 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00526409/
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
NCT00526305 — Acute Lymphoblastic Leukemia
Status: Completed
http://inclinicaltrials.com/acute-lymphoblastic-leukemia/NCT00526305/