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Anemia, Aplastic clinical trials

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NCT ID: NCT02099747 Completed - Clinical trials for Severe Aplastic Anemia

hATG+CsA vs hATG+CsA+Eltrombopag for SAA

RACE
Start date: July 2015
Phase: Phase 3
Study type: Interventional

The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

NCT ID: NCT02094417 Completed - Aplastic Anemia Clinical Trials

A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia

Start date: April 14, 2014
Phase: Phase 2
Study type: Interventional

The present study will be conducted to evaluate the efficacy and safety of AMG531 and to determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. Its efficacy and safety during the extension period beyond one year will also be evaluated.

NCT ID: NCT02065869 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant

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

This study will evaluate pediatric patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. The study will assess whether immune cells, called T cells, from the family donor, that are specially grown in the laboratory and given back to the patient along with the stem cell transplant can help the immune system recover faster after transplant. As a safety measure these T cells have been programmed with a self-destruct switch so that they can be destroyed if they start to react against tissues (Graft versus host disease).

NCT ID: NCT02065154 Completed - Lymphoma Clinical Trials

Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

Start date: August 27, 2013
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time.

NCT ID: NCT02055456 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Nandrolone Decanoate in the Treatment of Telomeropathies

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

Decrease in blood cell counts due to deficient bone marrow function, called bone marrow failure, as well as some lung diseases, called idiopathic pulmonary fibrosis, can be caused by genetic defects in telomere biology genes, eventually causing telomere erosion. These disorders are collectively termed "telomeropathies". There is evidence that male hormones may improve blood cell counts in marrow failure, and these hormones are able to stimulate telomerase function in hematopoietic cells in vitro. We propose this study to the use of male hormone in patients with aplastic anemia and pulmonary fibrosis associated with defects in telomeres.

NCT ID: NCT02028416 Recruiting - Aplastic Anemia Clinical Trials

Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic Anaemia

ATG
Start date: September 2013
Phase: N/A
Study type: Interventional

Acquired Aplastic anemia is one of the most frequent reason of bone marrow failure in East (Pakistan). - The first treatment option is Allogenic Bone Marrow transplantation which is an expansive treatment option and also require a full matched HLA identical donor, hence hardly 25% of our affected patients get opportunity for BMT. - The second line treatment option caters a large chunk of patients (severe and non-severe AA) along with those who lack HLA identical donor. Previously many protocols had been used in past for ATG+CsA Treatment, this treatment protocol especially addresses the two different regimens of ATG to study its efficacy, durability and long-term effects. Following doses would be used: - CsA+ATG @ 10mg/kg for 3 days - CsA+ATG @ 10mg/kg for 5 days

NCT ID: NCT02007811 Recruiting - Multiple Myeloma Clinical Trials

Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination

B-cell therapy
Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.

NCT ID: NCT01997372 Recruiting - Clinical trials for Severe Aplastic Anemia

Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia

Start date: December 2010
Phase: Phase 4
Study type: Interventional

Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.

NCT ID: NCT01995331 Active, not recruiting - Aplastic Anemia Clinical Trials

Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia

Start date: March 2012
Phase: Phase 4
Study type: Interventional

Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors associated with life-threatening complications. High-dose cyclophosphamide has been found to yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of cyclophosphamide for the treatment of children with SAA.

NCT ID: NCT01966367 Active, not recruiting - Sickle Cell Disease Clinical Trials

CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

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

This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the time to neutrophil and platelet engraftment, to determine the time to immune reconstitution (including normalization of T, B and natural killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence of infectious complications including bacterial, viral, fungal and atypical mycobacterial and other infections following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant disease.