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Brief Title Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoid Leukemia (ALL)
Official Title A Phase 1b, Open-Label, Dose Escalation and Expansion Study Evaluating the Safety and Efficacy of Entospletinib (GS-9973) With Vincristine and Dexamethasone in Adult Subjects With Relapsed or Refractory Acute Lymphoid Leukemia (ALL)
Principal Investigator Stock, Wendy
Brief Summary This study will evaluate the safety, efficacy, tolerability, and pharmacokinetics of entospletinib (GS-9973) in combination with vincristine (VCR), and dexamethasone in adults with previously treated relapsed or refractory B-cell lineage acute lymphoid leukemia (ALL). This study consists of two parts: Dose Escalation and Dose Expansion. After 2 induction cycles during either parts of the study, participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.
Gender Both
Ages 18 Years
Enrollment 35
Accepts Healthy Volunteers No
Lead Sponsor Gilead SciencesIndustry
Collaborator
Study Design Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Lymphoid Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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