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G-CSF

Phase 2

AML | Monoclonal antibody | Oncology |Amgen Inc.|Last Updated: Apr 6, 2017

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00636909Nonmyeloablative Allo SCT for the Treatment of Hematologic DisordersPHASE2 COMPLETED 25Jul 1, 1999 -Apr 6, 2017 -
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Study Endpoints
Primary Endpoints
durable engraftment
100 days
hematopoeitic reconstitution
3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
3 years
Secondary Endpoints
disease free survival and overall survival
3 years
incidence of treatment related toxicity and acute and chronic graft versus host disease
100 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALStudy treatment arm with G-CSF
Interventions
NameTypeDescription
CyclophosphamideDRUGpreparative cytoreduction
fludarabineDRUGpreparative cytoreduction
cyclosporineDRUGimmunosuppressive therapy
methotrexateDRUGimmunosuppressive therapy
G-CSFBIOLOGICALfoster engraftment
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Eligibility Criteria
Age RangeN/A — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria - Patient: * AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET * Age less than 65 years * Patients must have a healthy family mem...

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