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MDS clinical trials

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NCT ID: NCT02226861 Completed - MDS Clinical Trials

Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation

Start date: August 26, 2014
Phase: Phase 1
Study type: Interventional

Background: - Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: - To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: - Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. - Donors: age 18 80. Design: - Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. - Donors will be screened with medical history, physical exam, blood tests and tissue typing. - Recipients will stay in the hospital 3 6 weeks. - All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. - Recipients will have: - Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. - Bone marrow sample taken by needle. They will have 3 more after transplant. - Donors will have: - Filgrastim injected once daily for 5 6 days. - Stem and immune cells collected by another apheresis. - Recipients will get: - Eight 30-minute doses of radiation, sitting at a machine. - Donor immune cells by IV, 6 days before the transplant day. - Chemotherapy drugs by IV. <TAB><TAB>- Donor stem cells by IV on transplant day. - After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. - Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections - Recipients must stay near NIH for 3 6 months after transplant. - All recipients and donors will have 3 years of follow-up.

NCT ID: NCT02214407 Completed - MDS Clinical Trials

Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML

GFM-DAC-CMML
Start date: October 14, 2014
Phase: Phase 3
Study type: Interventional

This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with individual therapeutic benefit aim: Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML) The primary objective of the study is to compare between the two arms Event-free Survival (EFS). Secondary objectives are to compare between both arms: Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3 and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity (hematological and non hematological) Prognostic factors

NCT ID: NCT02197676 Completed - MDS Clinical Trials

A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

Start date: August 4, 2014
Phase: Phase 2
Study type: Interventional

Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.

NCT ID: NCT02193958 Completed - AML Clinical Trials

Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2a Dose Escalation Study of FF-10501-01 in Patients with Relapsed or Refractory Hematological Malignancies to determine the safety and tolerability. A total of 6 cohorts will be enrolled in Phase 1 to establish the MTD. A total of 20 subjects with MDS/CMML treated at the RP2D are planned, including MDS/CMML subjects treated at the RP2D in Phase 1.

NCT ID: NCT02167958 Completed - Lymphoma Clinical Trials

Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source

Start date: February 11, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether stem cells collected from a donor's blood stream will be as safe and effective as using bone marrow collected from a donor's pelvic bone.

NCT ID: NCT02161042 Completed - Anemia Clinical Trials

The Effect of Blood Transfusion on Endothelial Function

Start date: August 2011
Phase: N/A
Study type: Observational

Blood transfusion is often used to treat patients with Anemia. The period of storage of blood products prior to use for transfusion may vary. Prolonged storage of blood products may result in changing their biochemistry. This study aims to look into whether the transfusion of "old" blood, which is stored for more than 7 days, as compared to the transfusion of "Fresh" blood, which is stored for less than 7 days, will affect endothelial function.

NCT ID: NCT02103478 Completed - Clinical trials for Myelodysplastic Syndrome

Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)

Start date: October 28, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of ASTX727, as well as determined the dose for later stages.

NCT ID: NCT02016781 Completed - MDS Clinical Trials

Allo vs Hypomethylating/Best Supportive Care in MDS (BMTCTN1102)

Start date: December 16, 2013
Phase: Phase 2
Study type: Interventional

This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.

NCT ID: NCT01993641 Completed - Clinical trials for Myelodysplastic Syndrome

Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA

MEI-005
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this open label study is to determine whether combining pracinostat (study drug) with Vidaza (azacitidine) or Dacogen (decitabine) will improve clinical responses in Myelodysplastic Syndrome (MDS) patients who have failed an initial single agent hypomethylating agent (HMA), and to provide additional safety and efficacy data.

NCT ID: NCT01690507 Completed - AML Clinical Trials

Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML)

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.