Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/29/2018 |
| Start Date: | May 28, 2015 |
| End Date: | December 17, 2018 |
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)
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.
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.
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.
We found this trial at
11
sites
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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