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Anemia, Aplastic clinical trials

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NCT ID: NCT02960646 Completed - Clinical trials for Acute Myeloid Leukemia

Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Start date: January 18, 2017
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies the side effects of engineered donor stem cell transplant in treating patients with hematologic malignancies. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Using T cells specially selected from donor blood in the laboratory for transplant may stop this from happening.

NCT ID: NCT02918292 Completed - Clinical trials for Severe Aplastic Anemia

Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

CHAMP
Start date: July 3, 2017
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter phase II study with patients receiving haploidentical transplantation for Severe Aplastic Anemia (SAA). The primary objective is to assess overall survival (OS) at 1 year post-hematopoietic stem cell transplantation (HSCT).

NCT ID: NCT02875743 Completed - Clinical trials for Myelodysplastic Syndromes

King's Invasive Aspergillosis Study II

Start date: December 7, 2016
Phase: Phase 4
Study type: Interventional

Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation. This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.

NCT ID: NCT02833805 Completed - Immunosuppression Clinical Trials

NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia

Start date: September 2016
Phase: Phase 2
Study type: Interventional

Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.

NCT ID: NCT02773290 Completed - Aplastic Anemia Clinical Trials

Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia

Start date: May 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of romiplostim administered once weekly to Aplastic Anemia (AA) patients with thrombocytopenia refractory to or ineligible for immunosuppressive therapy in Japan and Korea. Safety and pharmacokinetics of romiplostim after repeated administration will also be assessed.

NCT ID: NCT02745717 Completed - Clinical trials for Severe Aplastic Anemia

The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy (IST). Study design: open-labed, prospective, multicenter, randomized control study Number of subjects: 60 each group Treatment: IST group: ATG (Thymoglobuline®, Genzyme) 3.5mg/kg/d×5d plus oral cyclosporine A (CSA) Cord blood transfusion group: In addition to the same dose and course of ATG and CSA , one unit of cord blood having no more than 2 HLA-A, B or DRB1 mismatches is transfused 24h after last dose of ATG administration.

NCT ID: NCT02462252 Completed - Aplastic Anemia Clinical Trials

Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome

Start date: October 2015
Phase: Phase 2
Study type: Interventional

An open label single arm study to assess efficacy and safety of BL-8040 on top of standard immunotherapy regimen of hATG, cyclosporine and steroids in patients with Hypoplastic MDS and AA over the course of a six month (180 day) treatment period.

NCT ID: NCT02404025 Completed - Aplastic Anemia Clinical Trials

Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects

Start date: May 12, 2015
Phase: Phase 2
Study type: Interventional

This was an open label, non-randomized, phase II study of eltrombopag in combination with rabbit ATG/CsA in subjects with moderate or more severe AA who did not received prior ATG/ALG-based immunosuppressive therapy. The objective was to assess additive effects of eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA. Subjects were assessed at least weekly for safety during the period from the start of ATG/CsA to 4 weeks after the start of administration of eltrombopag. After that, subjects had visits every 2 weeks until Week 26. Subjects in whom the treatment was assessed as effective at Week 26 could continued treatment with eltrombopag after 6 months when clinically indicated at the discretion of the investigator. There were five follow-up visits: at discontinuation of the treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment discontinuation. As this study was the first Japanese phase II study in which this product was administered in combination with ATG/CsA to subjects with naive moderate or more severe AA, the subject number of this study was determined to be 10 based on the feasibility survey.

NCT ID: NCT02277639 Completed - Immunodeficiencies Clinical Trials

Reduced Intensity Conditioning Using CD3+/CD19+ Depletion for Non Malignant Transplantable Diseases

MiniClini
Start date: November 2011
Phase: Phase 2
Study type: Interventional

This is a Phase II trial to determine the ability of a reduced intensity conditioning regimen to allow successful engraftment with CD3+ /CD19+ depleted peripheral stem cell grafts from mismatched donors. There are two conditioning regimens depending upon patient diagnosis and age.

NCT ID: NCT02225145 Completed - Aplastic Anemia Clinical Trials

Fertility Preservation in Women Who Will Have Gonadotoxic Therapy or Hematopoetic Stem Cell Transplantation, and in Women With Sickle Cell Disease

Start date: August 15, 2014
Phase:
Study type: Observational

Background: - Some treatments for cancer or other diseases can lead to infertility in women. These treatments include chemotherapy, some stem cell transplants, and pelvic radiotherapy. They are called gonadotoxic therapies. Women can now have their eggs frozen before they have these treatments. This may allow them to get pregnant later. Researchers want to learn more about this technology and processes. Objectives: - To provide egg freezing for women having gonadotoxic therapies at NIH. To learn more about the effects of these therapies. Eligibility: - Women at least 18 years old who are past puberty and before menopause. They must be scheduled to have gonadotoxic therapies. Design: - Participants will be screened with medical history and blood and hormone tests. They will also have a physical exam and transvaginal ultrasound. - Ovary stimulation: participants will have medications injected under the skin. These increase the chance of fertility. This phase will take about 8 20 days. Participants will have blood drawn and transvaginal ultrasound daily or every other day. Some participants will also have blood thinner injected daily. - Egg retrieval: participants will check in to the hospital. Eggs will be removed with a needle during a short surgery. Participants will be awake but sedated. - Participants may stay overnight in the hospital. - They will return every 1 3 days for 1 3 weeks for blood tests. - Mature eggs will be frozen after egg retrieval and immature eggs (which cannot be fertilized for clinical use) will be used for research. Participants can use their eggs in the future at outside, private fertility clinics to try to become pregnant. If the eggs are stored for more than 5 years, participants must pay for storage.