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Myelodysplastic Syndromes clinical trials

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NCT ID: NCT01749111 Terminated - Clinical trials for Myelodysplastic Syndrome

Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

CICLODECH
Start date: December 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

NCT ID: NCT01748240 Terminated - Clinical trials for Myelodysplastic Syndrome

Addition of Vorinostat to Azacitidine in Higher Risk MDS a Phase II add-on Study in Patients With Azacitidine Failure

GFM-AZA-VOR
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Azacytidine (AZA) is the current standard of care for frontline patient treated with high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this agents have shown more responses based on phase I/II data. In the present study, we will use the combination of these two drugs to try to create a synergetic effect and generate a response for patients who experienced treatment failure after AZA. All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days. Study Design

NCT ID: NCT01747499 Terminated - Clinical trials for Myelodysplastic Syndromes

Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation

Start date: April 15, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this phase I/II study is to define the maximum tolerated dose of 5-AzaC and the effect on grade II-IV GvHD when given after matched unrelated donor transplant (MUD).

NCT ID: NCT01746849 Active, not recruiting - Multiple Myeloma Clinical Trials

Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

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

The purpose of this study is to help determine if palifermin and leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant. The investigators want to see if palifermin and leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

NCT ID: NCT01745913 Terminated - Clinical trials for Myelodysplastic Syndrome

Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies

Start date: October 26, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is compare the efficacy of haplo-cord transplant (investigational arm) with that of a more commonly used procedure in which only the cells contained in one or two umbilical cords are infused (standard arm). We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus host disease, low frequency of delayed opportunistic infections, reduced transfusion requirements, shortened length of hospital stay and promising long term outcomes. We also hypothesize that umbilical cord blood selection can prioritize matching and better matched donors can be identified rapidly for most subjects.

NCT ID: NCT01744223 Active, not recruiting - Lymphoma Clinical Trials

Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant

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

This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.

NCT ID: NCT01739452 Completed - Clinical trials for Myelodysplastic Syndrome

Spanish Registry of Erythropoietic Stimulating Agents Study

SPRESAS
Start date: January 2013
Phase:
Study type: Observational

Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.

NCT ID: NCT01736683 Completed - Anemia Clinical Trials

Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

Start date: November 28, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).

NCT ID: NCT01736436 Completed - Clinical trials for Myelodysplastic Syndrome

APG101 in Myelodysplastic Syndrome

APG101 in MDS
Start date: January 2013
Phase: Phase 1
Study type: Interventional

It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients. APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate MDS patients suffering from anaemia. Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic Scoring Scale (WPSS) can be included in this study. Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months follow up phase. Primary objective of the trial is safety and tolerability of APG101; secondary objectives are - Hematologic, cytologic and cytogenetic response rate using modified International Working Group (IWG) response criteria - Incidence and time to leukemic progression at 37 weeks - OS (Overall survival) at 37 weeks

NCT ID: NCT01729845 Completed - Clinical trials for Recurrent Adult Acute Myeloid Leukemia

Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Start date: December 20, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of decitabine followed by mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells.