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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02404220 |
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Date of registration:
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02/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
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Scientific title:
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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) |
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Date of first enrolment:
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May 6, 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02404220 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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Germany
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United States
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Contacts
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Name:
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Gilead Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Intervention(s)
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Drug: Entospletinib
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Drug: Dexamethasone
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Drug: CNS Prophylaxis
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Drug: Vincristine
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Primary Outcome(s)
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Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
[Time Frame: ENTO Lead-in and Cycle 1 (Day -7 through Day 28)]
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Secondary Outcome(s)
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Percentage of Participants With Partial Response (PR) at the End of Induction
[Time Frame: End of Induction (Cycle 2, Day 28)]
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Percentage of Participants With Complete Remission (CR) at the End of Induction
[Time Frame: End of Induction (Cycle 2, Day 28)]
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Percentage of Participants With Overall Response at the End of Induction
[Time Frame: End of Induction (Cycle 2, Day 28)]
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Percentage of Participants With Overall Remission at the End of Induction
[Time Frame: End of Induction (Cycle 2, Day 28)]
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Secondary ID(s)
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2015-002768-18
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GS-US-339-1560
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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