Clinical trial NCT02404220: Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Syk inhibitor
Blood malignancy
Leukemia
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
timeFrame: ENTO Lead-in and Cycle 1 (Day -7 through Day 28)
Secondary outcomes:
measure: Percentage of Participants With Complete Remission (CR) at the End of Induction
timeFrame: End of Induction (Cycle 2, Day 28)
measure: Percentage of Participants With Overall Remission at the End of Induction
timeFrame: End of Induction (Cycle 2, Day 28)
measure: Percentage of Participants With Partial Response (PR) at the End of Induction
timeFrame: End of Induction (Cycle 2, Day 28)
measure: Percentage of Participants With Overall Response at the End of Induction
timeFrame: End of Induction (Cycle 2, Day 28)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego (UCSD)
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Greenville
country: United States
facility: Bon Secour St. Francis Hospital
state: South Carolina
city: Seattle
country: United States
facility: University of WA
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret
state: Ontario
city: Berlin
country: Germany
facility: Medizinische Klinik mit Schwerpunkt Hepatologie & Gastroenterology
city: Wurzburg
country: Germany
facility: Medizinische Klinik und Poliklinik I
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: