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Leukemia, Myeloid clinical trials

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NCT ID: NCT01515527 Recruiting - Leukemia Clinical Trials

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

Start date: February 7, 2012
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.

NCT ID: NCT01513603 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia

Start date: January 2012
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01513109 Recruiting - Clinical trials for Acute Myelogenous Leukemia

Safety and Immunogenicity of Recombinant WT1 Antigen-Specific Cancer Immunotherapeutic Combined With Infusion of Treg Depleted T Cells for Adult WT1 Acute Myeloid Leukemia

ASCI
Start date: December 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and the efficacy of combined treatment strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in vivo regulatory T cells depletion as post-consolidation therapy in patients with WT1-positive Acute Myeloid Leukemia. The study will also evaluate the clinical activity and immune response of this approach in bad risk patients in CR1 and all patients in CR2 or CR3, non eligible for an allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT01484171 Recruiting - Clinical trials for Acute Myeloid Leukemia

HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

Start date: August 2011
Phase: Phase 3
Study type: Interventional

To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).

NCT ID: NCT01464411 Recruiting - Clinical trials for Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

D-First
Start date: July 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.

NCT ID: NCT01423175 Recruiting - Clinical trials for Acute Myeloid Leukemia

ClAraC or FLAMSA Followed by Stem Cell Transplantation to Treat High Risk AML or Advanced MDS

ClAraC-SCT
Start date: July 2011
Phase: Phase 2
Study type: Interventional

ClAraC (consisting of one dose of clofarabine and ara-C for five days) or FLAMSA (consisting of one dose of fudarabine, amsacrine and ara-C for four days) will be administered followed by reduced-intensity conditioning regimen (RIC) in the setting of allogeneic stem cell transplantation (SCT). The aim of the study is to explore the antileukemic, immunosuppressive effects and toxicity and safety of clofarabine in combination with ara-C in the setting of RIC allogeneic transplantation compared with the FLAMSA-protocol for patients with high-risk acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS).

NCT ID: NCT01414231 Recruiting - Clinical trials for Acute Myeloid Leukaemia

Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a

OSHO#061
Start date: April 2002
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT01369368 Recruiting - Clinical trials for Acute Myeloid Leukemia

Treatment of Acute Leukemia Relapse After Allotransplantation

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.

NCT ID: NCT01351545 Recruiting - Hodgkin Lymphoma Clinical Trials

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Start date: October 2011
Phase:
Study type: Observational

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

NCT ID: NCT01316250 Recruiting - Clinical trials for Chronic Myelogenous Leukemia

Gleevec as Maintenance Therapy After Cytogenetic Response With Nilotinib in Newly Diagnosed Chronic Myelogenous Leukemia

Start date: August 2010
Phase: N/A
Study type: Interventional

The results of the International Randomized Study of Interferon and STI571 (IRIS) trial indicate that in patients with chronic phase CML treated with first line imatinib, achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is associated with a significantly better progression-free survival (PFS). Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in patients with previously untreated chronic phase CML, nilotinib results in a faster and higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet restriction and much higher financial cost. The primary objective of this study is to evaluate the ability of imatinib to maintain a complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of first-line treatment with nilotinib.