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Preleukemia clinical trials

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NCT ID: NCT01093586 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Start date: September 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, 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 antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.

NCT ID: NCT01088373 Completed - Clinical trials for Myelodysplastic Syndromes

Lenalidomide Combined to Azacitidine in Intermediate-2 or High Risk MDS With Del 5q

GFM-AZA-REV-09
Start date: March 25, 2010
Phase: Phase 2
Study type: Interventional

Higher risk MDS with del(5q) carry very poor prognosis, but show some response to azacitidine and Lenalidomide as single agents . The combination of Lenalidomide and Azacytidine is currently tested in non del 5q MDS patients. Preliminary results have been recently presented at ASH meeting (Sekeres et al, 2007). Overall, the combination of Lenalidomide and Azacitidine is well-tolerated and early results suggest some efficacy in advanced MDS without del 5q. In this trial, we will combine Lenalidomide to Azacytidine in higher risk MDS with del (5q). Patients will receive azacitidine( 75mg/m2/day for 5 days every 28 days) combined to escalating doses of lenalidomide (starting at relatively low dose). For patients in hematological CR, PR, HI or marrow CR after cycle 2 or 4, it is mandatory to continue on Azacitidine + Lenalidomide as long as there is no unacceptable toxicity or overt progression, with the schedule that yielded response. In patient still responding after 52 weeks, the drug will continue to be supplied, and follow up until death will be continued in all patients.

NCT ID: NCT01085838 Completed - Clinical trials for Myelodysplastic Syndrome

Erlotinib in Higher Risk Myelodysplastic Syndrome

Start date: July 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent.

NCT ID: NCT01083706 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well azacitidine works in treating patients with relapsed myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

NCT ID: NCT01081431 Completed - Clinical trials for Myelodysplastic Syndromes

Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q

MDS-LE-MON-5
Start date: March 26, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.

NCT ID: NCT01075425 Completed - Clinical trials for Acute Myeloid Leukemia

Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome

Start date: May 2010
Phase: Phase 1
Study type: Interventional

RATIONALE: Belinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving belinostat together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving belinostat together with bortezomib in treating patients with relapsed or refractory acute leukemia or myelodysplastic syndrome.

NCT ID: NCT01068301 Completed - Clinical trials for Acute Myeloid Leukemia

A Pediatric Study of a Plerixafor Containing Regimen In Second Allogeneic Stem Cell Transplantation

Start date: May 2010
Phase: Phase 1
Study type: Interventional

Patients with refractory hematologic malignancies, including those who develop recurrent disease after allogeneic hematopoietic stem cell transplantation (HSCT) have a dismal prognosis. Historically, both regimen-related mortality and disease recurrence have been significant causes of treatment failure in this heavily pre-treated patient population. Novel therapeutic agents that target molecular signaling mechanisms and increase the sensitivity of leukemic cells to apoptosis may clearly play a role in this setting. This study hypothesizes that interrupting the SDF-1/CXCR4 axis using the selective CXCR4 antagonist plerixafor may be useful as a leukemic stem cell mobilizing agent for patients who are refractory to standard dose chemotherapy and in relapse after an allogeneic transplant. This hypothesis is based on the dependence of leukemia cells on MSCs for survival signals as described above and on the preclinical data that suggest increased efficacy by antileukemia agents when leukemia cells are separated from MSCs. In the present trial, the study proposes to add plerixafor to enhance the conditioning regimen cytotoxicity. At this time the goal is to determine the maximum tolerated dose (MTD) of plerixafor through the process of dose limiting toxicity (DLT) evaluation. Pharmacokinetic studies will be conducted. Additional studies will quantify and the content of leukemia cells and key regulatory and effector T cell populations in the bone marrow and blood before and after exposure to this medication. If the observed outcomes of this trial are promising, it could serve as a platform on which to study further use of plerixafor as a complimentary agent with conditioning as well as other chemotherapeutic regimens for patients with relapsed or refractory hematologic malignancies.

NCT ID: NCT01065129 Completed - Clinical trials for Myelodysplastic Syndromes

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) in Combination With Azacitidine for the Treatment of Myelodysplastic Syndrome (MDS)

MDS
Start date: September 2, 2010
Phase: Phase 1
Study type: Interventional

Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and azacitidine in patients with MDS and determine the safety and tolerability of plerixafor + G-CSF and azacitidine.

NCT ID: NCT01063257 Completed - Clinical trials for Myelodysplastic Syndrome

Clofarabine in High Risk Myelodysplastic Syndrome (MDS)

Start date: April 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine.

NCT ID: NCT01062490 Completed - Clinical trials for Myelodysplastic Syndrome

Treosulfan Based Conditioning Myelodysplastic Syndrome (MDS)

Start date: November 2004
Phase: Phase 2
Study type: Interventional

This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with MDS. The aim is to demonstrate a clinical benefit compared to historical data with intravenous busulfan.