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Anti-Thymocyte globulin

Phase 2

Acute Leukemia | Small molecule | Oncology |Sanofi|Last Updated: May 11, 2025

Target and mechanism

ModalitySmall molecule

Also known as Antithymocyte globulin (ATG), Antithymocyte globulin, Anti-Thymocyte globulin (rabbit)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Anti-Thymocyte globulin · 2 trials · 4 indications

Phase 2 2
NCT04202835ATG Plus PTCy vs ATG for CGVHD ProphylaxisAcute Leukemia
ACTIVE NOT_RECRUITING80 Analytics
NCT00017550Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic SyndromeMyelodysplastic Syndromes
COMPLETED- Analytics
PHASE2ACTIVE NOT_RECRUITING
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
Acute LeukemiaUnlock trial analytics
PHASE2COMPLETED
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
Myelodysplastic SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Registration of 80 patients within twenty four months
24 months

Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)

Secondary Endpoints

CRFS
27 months
GRFS
27 months
Survival
27 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ATG/PTCyEXPERIMENTALAnti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.
ATGACTIVE_COMPARATORAnti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).

Interventions

NameTypeDescription
CyclophosphamideDRUGPost Transplant Cyclophosphamide
Anti-Thymocyte globulin (rabbit)DRUGAnti-Thymocyte Globulin (rabbit, Thymoglobulin)
anti-thymocyte globulinBIOLOGICAL -
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Eligibility Criteria

Age Range16 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. The participant is aged ≥ 16 and deemed medically fit per investigator for protocol 2. The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome 3. The participant will receive a blood progenitor cell graft ("HPC,...

Countries:AustraliaCanadaUnited States
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Frequently asked questions about Anti-Thymocyte globulin

What is Anti-Thymocyte globulin used for?

Anti-Thymocyte globulin (ATG) is used in the treatment of Myelodysplastic Syndromes and Acute Leukemia. It is being studied in clinical trials for these conditions, including a completed Phase 2 trial in Myelodysplastic Syndromes and an active Phase 2 trial in Acute Leukemia and Myelodysplasia.

What does Anti-Thymocyte globulin target?

Anti-Thymocyte globulin targets T lymphocytes, which are a type of white blood cell involved in the immune response. By depleting these cells, it modulates the immune system, which is relevant in the treatment of hematologic conditions like Myelodysplastic Syndromes and Acute Leukemia.

Who makes Anti-Thymocyte globulin?

Anti-Thymocyte globulin is developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY.

What phase is Anti-Thymocyte globulin in?

Anti-Thymocyte globulin is in Phase 2 clinical development. It has completed a Phase 2 trial in Myelodysplastic Syndromes and is currently in an active Phase 2 trial for Acute Leukemia and Myelodysplasia. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Anti-Thymocyte globulin in?

Anti-Thymocyte globulin is involved in two clinical trials. The first, NCT00017550, is a completed Phase 2 trial comparing ATG with supportive care in patients with Myelodysplastic Syndrome. The second, NCT04202835, is an active Phase 2 trial studying ATG plus PTCy versus ATG for chronic graft-versus-host disease prophylaxis in Acute Leukemia and Myelodysplasia.

Is Anti-Thymocyte globulin the same as Antithymocyte globulin?

Yes, Anti-Thymocyte globulin is also known as Antithymocyte globulin (ATG) and Anti-Thymocyte globulin (rabbit). These names refer to the same drug, which is developed by Sanofi and is being studied for Myelodysplastic Syndromes and Acute Leukemia.