Thymoglobuline

also known as Anti-lymphocyte serum · Anti-thymocyte globulin [rabbit] · Anti-thymocyte globulines · antithymocyte globulin · ATG · Thymoglobulin

Protein / enzyme biologic

Developed for: acute myeloid leukemia · hematopoietic and lymphoid cell neoplasm · graft versus host disease · hematologic disorder · lymphoid hemopathy · myelodysplastic syndrome
Investigated by: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation · Institut Paoli-Calmettes · Agence de La Biomédecine · Hadassah Medical Organization · King's College Hospital NHS Trust · Nantes University Hospital

Trials 7

today NCT03035422 · not/applicable NCT03079089 · not/applicable NCT02483325 · Ph 2 NCT01572181 · Ph 2 NCT00915811 · Ph 2 NCT00130754 · Ph 3 NCT00894049 · Ph 2

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 24 trials
Phase 2	NCT02483325	Sep 2014 → Mar 2018	hematologic disorder	Institut Paoli-Calmettes	Completed	No outcome recorded
Phase 2	NCT01572181	Apr 2012 → Oct 2017	hematopoietic and lymphoid cell neoplasm	Nantes University Hospital	Completed	No outcome recorded
Phase 2	NCT00915811	Jun 2007 → Jun 2011	acute myeloid leukemia, myelodysplastic syndrome	King's College Hospital NHS Trust	Terminated	No outcome recorded
Phase 2	NCT00894049	Nov 2002 → Feb 2013	cancer, disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm	Institut Paoli-Calmettes	Completed	No outcome recorded
Phase 31 trial
Phase 3	NCT00130754	Feb 2005 → Nov 2007	graft versus host disease	Hadassah Medical Organization	Completed	No outcome recorded
Phase not applicable2 trials
—	NCT03035422	Jan 2018 → Dec 2021	acute myeloid leukemia	Association for Training, Education, and Research in Hematology, Immunology, and Transplantation	Completed	No outcome recorded
—	NCT03079089	Jun 2017 → Sep 2023	lymphoid hemopathy	Association for Training, Education, and Research in Hematology, Immunology, and Transplantation	Completed	No outcome recorded
Comparator or background therapy4 trials
Phase 2	NCT00961142 Background	Jun 2009 → Dec 2015	acute lymphoblastic leukemia, acute myeloid leukemia	University Hospital Tuebingen	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00841724 Comparator	Jan 2009 → Jan 2012	hematopoietic and lymphoid cell neoplasm	Nantes University Hospital	Completed	No outcome recorded
Phase 3	NCT01145976 Background	Mar 2010 → Feb 2015	aplastic anemia	Cooperative Study Group A for Hematology	Unknown	Met primary
Phase 3	NCT00774527 Comparator	Mar 2003 → Feb 2010	bone marrow failure syndrome	Cooperative Study Group A for Hematology	Completed	No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

Field	Value	Cited text
Known as	Thymoglobuline	“Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2.” NCT01145976 ↗ 10 “Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2.” NCT00774527 ↗ “Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).” NCT00894049 ↗ “associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose” NCT02483325 ↗ “Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)” NCT03079089 ↗ “Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)” NCT03035422 ↗ NCT00841724 ↗ NCT00130754 ↗ NCT00961142 ↗ NCT01572181 ↗ NCT00915811 ↗
Known as	Anti-lymphocyte serum	“Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)” NCT03079089 ↗
Known as	Anti-thymocyte globulin [rabbit]	“Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme” NCT00915811 ↗
Known as	Anti-thymocyte globulines	“Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®)” NCT01572181 ↗
Known as	antithymocyte globulin	“antithymocyte globulin (Thymoglobulin®, Genzyme; 5 mg/kg total dose)” PMID 36028757 ↗ Aug 2022
Known as	ATG	“Fludarabine, Thiotepa, Melphalan, Thymoglobuline (ATG)” NCT00961142 ↗
Known as	Thymoglobulin	“Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®)” NCT01572181 ↗
Modality	Protein / enzyme biologic	“Thymoglobuline is a polyclonal rabbit antiserum specific for human T cells” NCT00130754 ↗
Route	Intravenous	“IV 7.5 mg/kg” NCT00130754 ↗