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Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
Not Recruiting
Trial ID: NCT02404220
Purpose
The primary objective of this study is to evaluate the safety of entospletinib in combination
with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or
refractory B-cell lineage acute lymphoblastic leukemia (ALL).
This is a dose escalation study in which after 2 induction cycles participants may be put on
maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.
Official Title
A Phase 1b/2, 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 Lymphoblastic Leukemia (ALL)
Stanford Investigator(s)
Michaela Liedtke
Associate Professor of Medicine (Hematology)
Eligibility
Key Inclusion Criteria:
- Adults with ALL in need of treatment
Key Exclusion Criteria:
- Diagnosis of Burkitt's Leukemia, or lymphoid blast crisis of chronic myelogenous
leukemia (CML)
- History of myelodysplastic syndrome or solid organ transplantation
- Prior allogeneic bone marrow progenitor cell transplant within 100 days or on active
immunosuppression for graft versus host disease (GVHD) treatment or prophylaxis within
28 days prior to enrollment
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention(s):
drug: Entospletinib
drug: Dexamethasone
drug: CNS Prophylaxis
drug: Vincristine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061