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mycophenolate or cyclosporine and methotrexate

Phase 2

Graft Versus Host Disease | Small molecule | Other |Bayer AG|Trials Updated: Jun 23, 2016

mycophenolate or cyclosporine and methotrexate development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

mycophenolate or cyclosporine and methotrexate clinical trials

mycophenolate or cyclosporine and methotrexate · 1 trial · 2 indications

Phase 2 1
NCT00775632Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell TransplantsGraft Versus Host Disease
COMPLETED78 Analytics
PHASE2COMPLETED
Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants
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Study Endpoints

Primary Endpoints

Chronic extensive GVHD at 1-year (yes vs. no)
12 months from the date of transplant
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard of CareACTIVE_COMPARATORThe current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Cyclosporine and CampathEXPERIMENTALThe efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.

Interventions

NameTypeDescription
AlemtuzumabDRUGA new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.
mycophenolate or cyclosporine and methotrexateDRUGOne of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
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Eligibility Criteria

Age Range16 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of a hematological malignancy * Peripheral blood as source of stem cells * Able to give informed consent * Availability of 6/6 matched sibling donor * Fit for transplant using a conventional or reduced intensity approach Exclusion Criteria: * AST/ALT \>3 x IULN at ...

Countries:Canada
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Competitive Landscape -Graft-versus-Host Disease 36 trials (matched to "Graft Versus Host Disease")

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