CLINICAL TRIALS PROFILE FOR EQUINE THYMOCYTE IMMUNE GLOBULIN
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All Clinical Trials for equine thymocyte immune globulin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00235781 ↗ | Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients | Terminated | Washington University School of Medicine | N/A | 2006-01-01 | The aim of this trial is to compare the safety and efficacy of a single dose of Thymoglobulin, rabbit derived antithymocyte globulin (Thymoglobulin, SangStat, Fremont, CA) to our standard four dose, four day Thymoglobulin induction regimen from the time of transplantation through a six month follow-up period. The primary endpoint will be the incidence of acute rejection. Secondary endpoints will include serious adverse events, evaluation of renal function, patient and graft survival, incidence of infectious complications, incidence of post-transplantation lymphoproliferative disorder (PTLD), duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune response to the allograft as well as duration of hospital stay. |
| NCT00923364 ↗ | Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC | Completed | National Cancer Institute (NCI) | Phase 2 | 2009-05-07 | Background: - Stem cells are immature blood cells that grow in the bone marrow and produce all of the cells needed for normal blood and immunity. Stem cells can be taken from one person (donor) and given to another person (recipient) through allogeneic stem cell transplantation. Donor stem cells can then replace the recipients stem cells in the bone marrow, restoring normal blood production and immunity. Most allogeneic transplants now use stem cells collected from the donors blood in a process called peripheral blood stem cell transplantation. - Monocytopenia and mycobacterial infection (MonoMAC) is an immunodeficiency disease that is characterized by a lack of monocytes, a type of white blood cell, and an increased risk of developing mycobacteria infections that may cause tuberculosis. - Allogeneic stem cell transplantation has been used successfully to treat many kinds of immune diseases and cancers that develop in blood or immune system cells. Researchers have been studying a particular kind of stem cell transplantation that uses lower than usual doses of chemotherapy and particular combinations of drugs to improve the results of the procedure for patients with blood-related cancers and pre-cancerous conditions. Objectives: - To determine the safety and efficacy of reduced-intensity hematopoietic stem cell transplants (a particular stem cell transplantation procedure) for treating MonoMAC. Eligibility: - Patients 18-60 years of age who have MonoMAC and who have been matched with a suitable stem cell donor. Design: - Donors and recipients will undergo separate procedures as part of this protocol. - Donors: - National Institutes of Health researchers will take the donor s medical history, perform a physical exam, take blood samples, and explain the procedure. Tests will be performed to check the donors heart, lung, kidney, and liver function. - Donors will receive injections of a drug called filgrastim (G-CSF), which causes stem cells to travel from bone marrow into blood. The G-CSF shots will be given for 5 to 7 days before the collection procedure. - Donors will undergo apheresis to collect white blood cells and stem cells directly from the blood, which can be done as an outpatient procedure. Researchers may consider the alternative of directly collecting bone marrow from the donor, which will require an overnight hospital stay. - Recipients: - Recipients will receive 3 days of pre-transplant chemotherapy and radiation therapy to prepare for the transplant. For 4 days before the transplant, recipients will receive the chemotherapy drug fludarabine, followed by a single dose of radiation therapy, and will also receive the drugs tacrolimus and sirolimus to prevent the donor cells from attacking the recipient s normal tissues. - Recipients will then receive the transplant of donor stem cells and will continue to receive tacrolimus and sirolimus for 3 months after the transplant to prevent the donor cells from attacking the recipient s normal tissues. Recipients will be discharged from the hospital once their condition is stable. - Recipients will visit the NCI clinic regularly for the first 5 months after the transplant, and then less often for at least 5 years. Recipients may receive additional donor immune cells (donor lymphocyte infusion) after the transplant if the study doctors believe they are needed. |
| NCT03663933 ↗ | Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation | Recruiting | National Cancer Institute (NCI) | Phase 2 | 2018-09-04 | Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to correct T-cell problems in some people. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with T-cell problems. Eligibility: Donors: Healthy people ages 4 and older Recipients: People the same age with abnormal T-cell function causing health problems Design: All participants will be screened with: - Medical history - Physical exam - Blood, heart, and urine tests Donors will also have an electrocardiogram and chest x-ray. They may have veins tested or a pre-anesthesia test. Recipients will also have lung tests. Some participants will have scans and/or bone marrow collected by needle in the hip bones. Donors will learn about medicines and activities to avoid and repeat some screening tests. Some donors will stay in the hospital overnight and have bone marrow collected with anesthesia. Other donors will get shots for several days to stimulate cells. They will have blood removed by plastic tube (IV) in an arm vein. A machine will remove stem cells and return the rest of the blood to the other arm. Recipients will have: - More bone marrow and a small fragment of bone removed - Dental, diet, and social worker consultations - Scans - Chemotherapy and antibody therapy for 2 weeks - Catheter inserted in a chest or neck vein to receive donor stem cells - A hospital stay for several weeks with more medicines and procedures - Multiple follow-up visits |
| NCT04862221 ↗ | TReatment for ImmUne Mediated PathopHysiology | Not yet recruiting | Ann & Robert H Lurie Children's Hospital of Chicago | Phase 2 | 2021-08-01 | TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure. The study will determine if suppressing inflammatory responses with either corticosteroids or equine anti-thymocyte globulin therapy improves survival for children with this rare, life-threatening condition. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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| Sponsor Name for equine thymocyte immune globulin | |
| Sponsor | Trials |
| National Cancer Institute (NCI) | 2 |
| Ann & Robert H Lurie Children's Hospital of Chicago | 1 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 1 |
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