Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric...
Pediatric Acute Myelogenous Leukemia (AML)The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.
LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
AMLThe purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission. At the same time, the study evaluate the security of lenalidomide.
Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant...
Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities13 moreRATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated radiation therapy 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. 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving intensity-modulated radiation therapy together with busulfan and etoposide before a transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy when given together with busulfan and etoposide followed by a donor stem cell transplant and to see how well it works in treating patients with advanced myeloid cancer.
A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Transplantation...
Acute Myelogenous Leukemia (AML)Chronic Myelogenous Leukemia (CML)3 moreThe purpose of this study is to determine the safety and effectiveness of administering Wilms tumor gene 1 (WT1) cancer peptides. Cancer peptides are short pieces of protein that are made in a laboratory to be like the peptides that can be found in cancer. These peptides are intended to be given as a "vaccine" to activate the immune cells in a person to attack his/her cancer. These peptides are mixed with an oily substance called Montanide ISA-51 and a white cell growth factor called Granulocyte-macrophage colony-stimulating factor (GM-CSF) which may help make the immune response stronger.
Liposomal Annamycin in Children and Young Adults With Refractory or Relapsed ALL or AML
Acute Lymphocytic LeukemiaAcute Myelogenous LeukemiaThis is a Phase I, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. Enrollment will occur in cohorts of approximately 3 subjects with 10 additional subjects enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Six dose levels of liposomal annamycin are planned: 130, 160, 190, 230, 280, and 310 mg/m2/day.The primary objectives of this study are 1) to evaluate the safety and identify the maximum tolerated dose (MTD) of liposomal annamycin when given in 3 consecutive daily doses, starting at 130 mg/m2/day and ranging to as high as 310 mg/m2/day, or the MTD, whichever is lower, in children and young adults with refractory or relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML), and 2) to evaluate the antileukemic activity of liposomal annamycin in children and young adults with refractory or relapsed ALL or AML. The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
Multidrug Resistance Genes in Patients With Acute Myeloid Leukemia
LeukemiaThis research trial studies multidrug resistance genes in patients with acute myeloid leukemia. Studying samples of bone marrow or blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn more about drug resistance and how patients respond to treatment.
Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral...
Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in Remission83 moreRATIONALE: Giving chemotherapy and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they will help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving colony-stimulating factors, such as filgrastim (G-CSF) and plerixafor, to the donor helps the stem cells move (mobilization) from the bone marrow to the blood so they can be collected and stored. PURPOSE: This clinical trial is studying giving plerixafor and filgrastim together for mobilization of donor peripheral blood stem cells before a peripheral blood stem cell transplant in treating patients with hematologic malignancies
Trial of Pimasertib in Hematological Malignancies
LeukemiaMyeloid2 moreThis is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts: Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies. Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.
Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed...
Acute Myeloid LeukemiaAcute Lymphocytic Leukemia6 moreThis is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed or refractory hematologic malignancies. The study will also characterize Cliquinol's safety, tolerability and pharmacodynamic effect.
A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia....
Acute Myeloid LeukemiaIn this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.