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Atgam Medical Research Studies

Up-to-date List of Atgam Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Atgam Medical Research Studies

Rank Status Study
1 Recruiting Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi Anemia
Condition: Fanconi Anemia
Interventions: Biological: anti-thymocyte globulin;   Drug: cyclophosphamide;   Drug: fludarabine phosphate;   Procedure: hematopoietic stem cell transplantation;   Drug: methylprednisolone;   Drug: filgrastim;   Drug: cyclosporine;   Drug: Mycophenolate Mofetil
Outcome Measures: Graft failure;   Incidence of Acute Graft-Versus-Host Disease (GVHD);   Overall survival;   Incidence of Chronic Graft-Versus-Host Disease (GVHD);   Transplant Related Deaths
2 Recruiting Carmustine, Etoposide, Cytarabine, Melphalan, and Antithymocyte Globulin Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Autoimmune Neurologic Disease That Did Not Respond to Previous Therapy
Condition: Autoimmune Disorder
Interventions: Biological: anti-thymocyte globulin;   Drug: carmustine;   Drug: cytarabine;   Drug: etoposide;   Drug: melphalan;   Drug: prednisone;   Procedure: autologous hematopoietic stem cell transplantation;   Procedure: peripheral blood stem cell transplantation;   Procedure: syngeneic bone marrow transplantation;   Other: laboratory biomarker analysis
Outcome Measures: Incidence of grades 4-5 regimen-related toxicity as assessed by the Regimen Related Toxicity Scale;   Transplant-related mortality;   Disease responses as assessed by clinical, laboratory and radiologic evaluation;   Engraftment kinetics;   Efficacy of peripheral blood stem cell mobilization from syngeneic donors and autograft recipients
3 Recruiting Horse ATG in Patients With AA or Low/Int-1 Risk MDS
Condition: Leukemia
Interventions: Drug: hATG;   Drug: Cyclosporine;   Drug: Methylprednisone;   Drug: Pegfilgrastim;   Drug: Filgrastim
Outcome Measures: Achievement of Response;   Time to Response
4 Recruiting Belatacept Early Steroid Withdrawal Trial
Condition: Renal Transplantation
Interventions: Drug: Alemtuzumab;   Drug: rabbit antithymocyte globulin;   Drug: Belatacept;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil;   Drug: early cessation of steroids
Outcome Measures: Composite endpoint;   Secondary endpoint
5 Recruiting Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies
Condition: Haemato-lymphoid Malignancies or Syndromes in Whom Allogeneic Stem Cell Transplantation is Warranted
Intervention: Drug: total lymphoid irradiation and anti-thymocyte globulin
Outcome Measures: To evaluate the incidence of non-relapse mortality (NRM);   Neutrophil and platelets recovery and chimerism measurement;   T cell subsets, regulatory cells, NK cells and B cells measurement;   Number of relapse, acute and chronic GVHD
6 Recruiting Zevalin Before Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Conditions: Refractory Non Hodgkin Lymphoma;   Relapsed Non Hodgkin Lymphoma
Interventions: Biological: rituximab;   Biological: ibritumomab tiuxetan;   Biological: anti-thymocyte globulin;   Radiation: total nodal irradiation;   Procedure: peripheral blood stem cell transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Drug: cyclosporine;   Drug: mycophenolate mofetil;   Other: laboratory biomarker analysis
Outcome Measures: Response conversion rate (PD/SD to PR and CR);   Time to engraftment/chimerism;   Rate of acute GVHD;   Rate of chronic GVHD;   Overall survival;   EFS;   Toxicities
7 Unknown  Total Lymphoid Irradiation and Anti-Thymocyte Globulin in the Allogeneic Hematopoietic Cell Transplantation
Condition: Hematologic Malignancies
Outcome Measure: Primary Outcome Measure not applicable
8 Unknown  HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors
Conditions: Acute Leukemia;   Myelodysplastic Syndrome;   Solid Tumors
Interventions: Biological: anti-thymocyte globulin;   Biological: filgrastim;   Radiation: Total body irradiation;   Drug: Fludarabine;   Drug: cyclophosphamide;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil;   Drug: Rituximab
Outcome Measures: Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.;   Engraftment and graft failure rates;   Incidence of acute GVHD;   Treatment related mortality;   Relapse rate and overall survival
9 Recruiting Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant
Condition: Cancer
Interventions: Biological: anti-thymocyte globulin;   Biological: rituximab;   Drug: clofarabine;   Procedure: stem cell transplantation
Outcome Measures: Donor engraftment;   Treatment-related Death;   Time to primary neutrophil engraftment;   Overall Survival;   Chimerism;   Acute graft-vs-host disease
10 Recruiting Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
Condition: Leukemia, GVHD, ATG, Transplantation
Intervention: Drug: anti thymoglobulin
Outcome Measure: Incidence of acute GVHD, and chronic GVHD
11 Recruiting Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin
Interventions: Procedure: Stem cell infusion;   Procedure: TLI;   Drug: Anti-thymocyte globulin;   Drug: Solumedrol;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil
Outcome Measures: Determine the event free survival;   Determine the toxicities;   To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism.;   To evaluate the incidence and extent of acute and chronic GVHD.;   To evaluate the overall and non-relapse mortality rate.;   Incidence of chemotherapy-associated pneumonitis
12 Recruiting Viral Infection in Haploidentical HSCT With ATG for Acute Graft-versus-host Disease Prophylaxis
Conditions: Hematopoietic Stem Cell Transplantation;   Antithymocyte Globulin;   Viral Infection
Intervention: Drug: ATG
Outcome Measures: Incidence of Epstein-Barr virus(EBV)and cytomegalovirus(CMV) infections;   Incidence of GVHD;   Drug-related adverse events of ATG;   Immune reconstitution;   Survival
13 Recruiting Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant
Conditions: Myeloproliferative Disorders;   Leukemia;   Lymphoma;   Myelodysplastic Syndromes
Interventions: Biological: anti-thymocyte globulin;   Drug: cyclophosphamide;   Drug: Fludarabine;   Drug: mycophenolate mofetil;   Procedure: umbilical cord blood transplantation;   Radiation: total body irradiation;   Drug: Sirolimus
Outcome Measures: Overall Survival;   Incidence of Non-relapse mortality;   Chimerism Values;   Incidence of neutrophil engraftment;   Incidence of platelet engraftment;   Incidence of acute graft-versus-host disease (GVHD);   Incidence of Chronic Graft-Versus-Host Disease;   Progression-free survival;   Incidence of relapse
14 Not yet recruiting Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Patients With Hematologic Malignancies
Conditions: Acute Myeloid Leukemia;   Hematologic Malignancies;   Acute Lymphocytic Leukemia;   Non Hodgkin Lymphoma;   Hodgkin Lymphoma,;   Multiple Myeloma;   Myelodysplastic Syndrome;   Chronic Lymphocytic Leukemia;   Chronic Myeloid Leukemia;   Myelofibrosis;   Myeloproliferative Syndrome
Interventions: Radiation: total marrow irradiation;   Drug: fludarabine phosphate;   Drug: busulfan;   Procedure: myeloid progenitor cell transplantation;   Biological: anti-thymocyte globulin;   Drug: tacrolimus;   Drug: methotrexate;   Other: laboratory biomarker analysis
Outcome Measures: Maximum tolerated dose of targeted marrow irradiation defined as the dose level immediately below that in which greater than or equal to 2/6 subjects experience a dose limiting toxicity assessed using NCI CTCAE version 4.0;   Incidence of toxicities assessed using NCI CTCAE version 4.0;   Patient mortality;   Organ avoidance;   Target coverage;   Planning time;   Treatment delivery time;   Disease response status, assessed by standard criteria for the presence of relapse;   Rates of acute GVHD, graded and staged according to the Blood and Marrow Transplant Clinical Trials Network Manual of Operations
15 Not yet recruiting Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
Conditions: Adult Acute Lymphoblastic Leukemia in Remission;   Adult Acute Myeloid Leukemia in Remission;   Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;   Adult Acute Myeloid Leukemia With Del(5q);   Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);   Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);   Adult Acute Myeloid Leukemia With t(16;16)(p13;q22);   Adult Acute Myeloid Leukemia With t(8;21)(q22;q22);   de Novo Myelodysplastic Syndromes;   Previously Treated Myelodysplastic Syndromes;   Recurrent Adult Acute Lymphoblastic Leukemia;   Recurrent Adult Acute Myeloid Leukemia;   Secondary Myelodysplastic Syndromes;   Untreated Adult Acute Lymphoblastic Leukemia;   Untreated Adult Acute Myeloid Leukemia
Interventions: Radiation: radiation therapy;   Drug: cyclophosphamide;   Biological: anti-thymocyte globulin;   Drug: tacrolimus;   Drug: methotrexate;   Procedure: allogeneic bone marrow transplantation;   Procedure: allogeneic hematopoietic stem cell transplantation;   Procedure: peripheral blood stem cell transplantation;   Other: laboratory biomarker analysis
Outcome Measures: TRM, defined as death occurring in a patient from causes other than disease relapse;   Rate of grade II/III organ toxicity, defined by the Bearman Regimen-Related Toxicities Scale;   TRM;   Donor chimerism;   Incidence of aGVHD, graded according to Ohio State University Bone Marrow Transplant (OSU BMT) Program policy;   Incidence of chronic GVHD, scored according to the OSU BMT Program policy;   Cumulative incidence of grade II organ toxicity;   Incidence of hematopoietic recovery;   Incidence of graft failure;   Rate of infectious complications;   Incidence of relapse;   Overall survival;   Progression-free survival;   Immune reconstitution
16 Recruiting Preemptive Therapy of GVHD
Condition: Graft-vs-host Disease
Intervention: Drug: rabbit antithymocyte globulin
Outcome Measures: Cumulative incidence of significant GVHD;   Survival free of relapse and significant GVHD;   Quality of life
17 Recruiting Donor Stem Cell Transplant After Busulfan, Fludarabine, Methylprednisolone, and Antithymocyte Globulin in Treating Patients With Bone Marrow Failure Syndrome
Conditions: Leukemia;   Myelodysplastic Syndromes;   Nonmalignant Neoplasm;   Paroxysmal Nocturnal Hemoglobinuria
Intervention: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Outcome Measures: Donor cell engraftment;   Regimen-related toxicities as assessed by NCI's Common Toxicity Criteria;   Acute and chronic GVHD;   overall survival;   event-free survival
18 Recruiting Early Diagnosis and Stem Cell Transplantation for Severe Immunodeficiency Diseases
Condition: Severe Immunodeficiency Diseases
Intervention: Drug: Fludarabine, Busulfan, and Anti-Thymocyte Globulin
Outcome Measures: To evaluate the efficacy of an optimized reduced intensity conditioning regimen using Fludarabine, Busulfan, and Anti-Thymocyte Globulin in preparing severe immunodeficiency patients for allogeneic hematopoietic progenitor cell transplantation;   To prospectively follow the natural course of severe immunodeficiency diseases after transplantation;   To measure the outcomes after stem cell transplantation using the reduced intensity transplant regimen.
19 Recruiting SCT for Dyskeratosis Congenita or SAA
Conditions: Dyskeratosis Congenita;   Aplastic Anemia
Interventions: Drug: Campath 1H;   Drug: Cyclophosphamide;   Drug: Fludarabine;   Procedure: Total Body Irradiation;   Procedure: Stem Cell Transplantation;   Drug: antithymocyte globulin;   Drug: Methylprednisolone
Outcome Measures: Neutrophil Engraftment;   Incidence of Regimen Related Mortality at 100 days;   Incidence of Chronic GVHD;   Incidence of Late Secondary Malignancies;   Incidence of grade 2-4 and 3-4 acute graft versus host disease (GVHD);   Overall Survival;   Incidence of Pulmonary Complications
20 Recruiting Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders
Condition: Nonmalignant Neoplasm
Interventions: Drug: treosulfan;   Drug: fludarabine phosphate;   Biological: anti-thymocyte globulin;   Radiation: total-body irradiation;   Procedure: allogeneic bone marrow transplantation;   Procedure: peripheral blood stem cell transplantation;   Procedure: umbilical cord blood transplantation;   Drug: tacrolimus;   Drug: methotrexate;   Drug: cyclosporine;   Drug: mycophenolate mofetil;   Other: laboratory biomarker analysis
Outcome Measures: Preliminary efficacy as defined by engraftment of a regimen consisting of treosulfan and fludarabine phosphate followed by allogeneic HCT in patients with nonmalignant inherited disorders;   Non-relapse mortality;   Incidence of grade II-IV acute GVHD;   Incidence of chronic GVHD;   Donor chimerism;   Disease response following HCT;   Immune reconstitution following HCT;   Incidence of infections;   Overall survival

These studies may lead to new treatments and are adding insight into Atgam etiology and treatment.

A major focus of Atgam research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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