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MDS clinical trials

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NCT ID: NCT02053545 Withdrawn - Lymphoma Clinical Trials

Haplo-identical SCT for High Risk (HR) Hematologic Malignancies w/Post-Transplant In-Vivo T-cell Depletion

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

Although a majority of children with leukemia and most hematological malignancies (Hodgkin's and Non-Hodgkin's lymphomas) can be cured with conventional chemotherapy, a subset of patients with resistant/recurrent high-risk disease are not cured with conventional treatment regimens. Investigators hypothesize that HSCT from a partially matched donor can be safe and effective for patients with very high risk hematologic malignancies when combined with post-transplant cyclophosphamide for prevention of graft-vs-host disease (GVHD).

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: NCT01861106 Recruiting - MDS Clinical Trials

Allogeneic Hematopoietic Stem Cell Transplant for GATA2 Mutations

Start date: July 24, 2013
Phase: Phase 2
Study type: Interventional

Background: - GATA2 deficiency is a disease caused by mutations in the GATA2 gene. It can cause different types of leukemia and other diseases. Researchers want to see if a stem cell transplant can be used to treat this condition. A stem cell transplant will give stem cells from a matching donor (related or unrelated) to a recipient. It will allow the donor stem cells to produce healthy bone marrow and blood cells that will attack the recipient s cancer cells. Objectives: - To see if stem cell transplants are successful at treating GATA2 mutations and related conditions. Eligibility: - Recipients who are between 8 and 70 years of age and have GATA2 deficiency. Design: - All participants will be screened with a physical exam and medical history. Blood samples will be collected. Recipients will have imaging studies and other tests. - Recipients will have chemotherapy or radiation to prepare for the transplant. On the day of the transplant, they will receive the donated stem cells. - Recipients will stay in the hospital until their condition is stable after transplant. - Frequent blood tests and scans will be required for the first 6 months after the transplant, followed by less frequent visits over time.

NCT ID: NCT01718366 Active, not recruiting - MDS Clinical Trials

A Study of Combined Deferasirox, Vitamin D and Azacytidine in High Risk MDS

GFM-EXVD-AZA
Start date: February 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine in treatment of high risk MDS Deferasirox Exjade: The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is scheduled during the phase I, with 5 additional patients per group. The maximal tolerated dose of Deferasirox will be required for the phase II of the study. The first dose will be assigned according to the ferritin level of the patient at time of inclusion: 5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin is ≥1000ng/ml) in Group 2 Group 1 : Ferritin 300 to 1000ng /ml: - cohort 1 : 5 mg/kg/d - cohort 2 : 10mg/kg/d - cohort 3 : 15 mg/kg/d Group 2 : Ferritin > 1000ng /ml: - cohort 1 : 10 mg/kg/d - cohort 2 : 15mg/kg/d - cohort 3 : 20 mg/kg/d 5 patients will be treated by cohort. In absence of toxicity (extra-hematological toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included in the next cohort. Deferasirox will be administrated once daily during all the study period. Uvedose will be administrated once weekly during all the study period (100.000 UI P.O). Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each cycles(One cycle is 28 days) During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment. No dose modification of deferasirox will be done after 3 cycles of treatment except in case of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with the same dose of Deferasirox until progression .

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.

NCT ID: NCT01584531 Completed - Clinical trials for Myelodysplastic Syndrome

Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome

ONTARGET
Start date: May 2012
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS) classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2 (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent. Rigosertib will be taken on days 1 to 21 of a 21-day cycle.

NCT ID: NCT01535456 Terminated - AML Clinical Trials

FLT-PET Imaging for MDS

Start date: July 2012
Phase: N/A
Study type: Interventional

The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.

NCT ID: NCT01497145 Completed - MDS Clinical Trials

A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

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

This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.

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).