Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-15011

Full Title

A Phase Ib/II, 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)

Purpose

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.

Are you eligible?

Inclusion Criteria:

Adults with ALL in need of treatment

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

Leukemia