Active clinical trials for "Leukemia, Myeloid, Acute"

Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).

Advances in the biological characterization of AML can now make a proper estimate of the risk of recurrence and likelihood of survival of different groups of patients according to the expression of different disease parameters. Karyotype, the molecular alterations affecting genes FLT3, NPM1 and CEBPA, minimal residual disease by flow cytometry and response to first induction cycle are variables that must be taken into consideration when planning the treatment of first line from a patient with AML. This breakthrough in the field of biology has not resulted yet in the development of new drugs really effective in the treatment of AML. Therefore, the core of the treatment continue to rely on the use of traditional chemotherapy combined or not with allogeneic hematopoietic stem cell. Both treatments differ in their antileukemic efficacy, higher in aloTPH, as well as their toxicity and procedure-related mortality, increased also in the aloTPH. These aspects should be added that most candidates aloTPH patients lack an HLA identical sibling donor forcing the search for alternative sources and hematopoietic stem cell donors. These transplants alternative, but are not committed to their antileukemic efficacy, it does have implied a greater toxicity. Therefore, the ultimate effectiveness of these procedures depends largely on the proper selection of candidates for the same. While there is broad agreement in terms of induction chemotherapy using a combination of cytarabine with anthracycline, the choice of chemotherapy regimen is controversial postremisión today. In the poor prognosis of itself involve the LMA, patients classified as "favorable group" are acceptable disease-free survival with consolidation schemes involving high-dose cytarabine. For other patients appear to be inappropriate to combine cytarabine with an anthracycline, at least one cycle of consolidation, and raise the option of allogeneic different depending on prognostic markers

This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis involves primarily dosing and application of AraC for induction. It is expected that CR rates and as a consequence also LFS are higher in protocols using higher AraC compared to lower doses and that LFS might be superior in the study specific arm compared to the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m*2 over 20-30-min-iv on day 1 - 3 and AraC 2 x 1 g/m*2 bid over 3-h-iv on days 1+3+5+7. A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates evaluated. It is still unclear if two consolidation therapies are needed before allogeneic or autologous stem cell transplantation. This question is being addressed in the second part of the OSHO study, where patients are randomized to receive either one or two consolidation therapies. In this study all patients with AML and an age of 18-60 years except M3 are entered

Study Design: prospective phase II trial with 30 patients in 1 site Treatment Scheme: Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -6 to -3 TBI 2x2 Gy day -3 to -2 (total dose 8 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0 Option 2: Patient > 60 years of age or younger patients < 12 Months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -3 to -1 TBI 1x2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0

This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.

Dendritic cell therapy is a promising strategy for adjuvant cancer therapy in the setting of minimal residual disease (MRD) to fight off cancer relapse and/or progression. The investigators already performed a phase I safety study in leukemia patients that were in complete remission demonstrating the absence of side effects and feasibility of the therapy. Here, the investigators want to extend on this strategy by studying the clinical efficacy of autologous DC vaccination in patients with acute and chronic myeloid leukemia and myeloma patients. Effects of DC therapy on the immune reactivity towards leukemia cells as well as clinical parameters such molecular MRD monitoring, time to relapse (TTR), progression-free survival (PFS) and overall survival(OS) will be studied in vaccinated and non-vaccinated (control) patients. Patients will be vaccinated using their own dendritic cells electroporated with mRNA coding for the full-length Wilms' tumor antigen WT1.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT). The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry. The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.

The purpose of this study is to explore safety, tolerability, including the maximum tolerated dose, and antitumor activity of NMS-03592088 in adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML).