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Myelodysplastic Syndromes clinical trials

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NCT ID: NCT01323920 Completed - Lymphoma Clinical Trials

Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors

Start date: May 2011
Phase: Phase 2
Study type: Interventional

A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.

NCT ID: NCT01314599 Completed - Acute Leukemia Clinical Trials

Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome

Start date: May 2011
Phase: Phase 1
Study type: Interventional

Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183.

NCT ID: NCT01305460 Completed - Clinical trials for Myelodysplastic Syndrome

Intensified Azacitidine in High Risk Myelodysplastic Syndrome (MDS)

Start date: July 5, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients.

NCT ID: NCT01305200 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

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

This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.

NCT ID: NCT01305135 Completed - Clinical trials for High Grade Myelodysplastic Syndrome Lesions

Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

Start date: December 30, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing. For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS. For the phase II study: Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS

NCT ID: NCT01300572 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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 FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

NCT ID: NCT01297543 Completed - Clinical trials for Acute Myeloid Leukemia

Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

Start date: March 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.

NCT ID: NCT01295710 Completed - Clinical trials for Myelodysplastic Syndrome

Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Start date: October 10, 2011
Phase: Phase 3
Study type: Interventional

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

NCT ID: NCT01290302 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia

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

The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.

NCT ID: NCT01289457 Completed - Leukemia Clinical Trials

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Start date: February 2, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.