Trial Search Results

Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

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 lymphoblastic 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Entospletinib
  • Drug: VCR
  • Drug: Dexamethasone
  • Drug: CNS Prophylaxis

Phase:

Phase 1/Phase 2

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Uzma Ahmed
650-723-0670
Recruiting