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ATLG

Phase 3

Hematopoietic Stem Cell Transplantation | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Jul 29, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06525519Comparison of Different Dose of Anti-T Lymphocyte Globulin (ATLG) in Haploidentical HSCT for GVHD ProphylaxisPHASE3 NOT YET_RECRUITING 104Jul 31, 2024Jul 31, 2026Jul 29, 20245 China
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Study Endpoints
Primary Endpoints
Incidence of grade II-IV acute Graft Versus Host Disease (GVHD)
At day 100 post-transplantation

aGVHD was graded according to standard criteria

Secondary Endpoints
Incidence of moderate to severe chronic GVHD (cGVHD)
1 year
Incidence of Epstein-Barr virus(EBV) viremia
180 days
Survival without relapse and moderate to severe GVHD
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATLG-20 mg/kgEXPERIMENTALATLG 20mg/kg group refers to treatment with ATLG in the total dose of 20mg/kg.
ATLG-30mg/kgEXPERIMENTALATLG 30mg/kg group refers to treatment with ATLG in the total dose of 30mg/kg.
Interventions
NameTypeDescription
ATLGDRUG5 mg/kg/day IV for 4 consecutive days (day-5 to -2 before transplantation). All transplant recipients will receive myeloablative conditioning or modified myoloablative conditioning and standard GVHD prophylaxis.
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Eligibility Criteria
Age Range16 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * 1,Age ≥ 16 and ≤ 65 years 2, Patients undergoing Haplo-identical hematopoietic stem cell transplantation 3, AML and ALL in complete cytologic response or MDS requiring allogeneic stem cell transplantation 4, ECOG performance status ≤ 2 Exclusion Criteria: * 1,Pregnant or lac...

Countries:China
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