Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

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 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)

Keywords

Acute Lymphoblastic Leukemia Syk inhibitor Blood malignancy Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Dexamethasone acetate Dexamethasone Vincristine BB 1101 Entospletinib VCR CNS Prophylaxis

Eligibility

For people ages 18 years and up

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.

Locations

  • University of California San Diego (UCSD)
    San Diego California 92093 United States
  • City of Hope
    Duarte California 91010 United States
  • UCLA
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02404220
Phase
Phase 1/2
Study Type
Interventional
Last Updated
May 10, 2018