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

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Brief Title

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)

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

Secondary Outcome

 Percentage of Participants With Complete Remission (CR) at the End of Induction

Condition

Acute Lymphoblastic Leukemia

Intervention

Entospletinib

Study Arms / Comparison Groups

 ENTO 200 mg + VCR 0.5 mg
Description:  Monotherapy Lead-In (Day -7 to Day -1): Entospletinib (ENTO) 200 mg tablet orally twice daily as a single agent.
Induction (two 28-day cycles): ENTO 200 mg twice daily continuously in combination with vincristine (VCR) 0.5 mg intravenously (IV) on Days 1, 8, 15, and 22 of each cycle; dexamethasone (DEX) 20 mg twice daily orally on Days 8-11 and Days 22-25 (Cycle 1) and on Days 1-4 and Days 15-18 (Cycle 2); and central nervous system (CNS) prophylaxis per institutional standards on Day 28 of each cycle.
Maintenance (up to 36, 28-day cycles): Participants who achieved a complete remission (CR) received stem cell transplant (SCT) (if eligible) per investigator's discretion; others who obtained clinical benefit (ie, at least a partial response [PR]) after induction were offered maintenance therapy with ENTO 200 mg twice daily continuously in combination with VCR 0.5 mg on Day 1 of each cycle and DEX (20 mg daily or 10 mg twice daily) on Days 1-4 and Days 15-18 of each cycle.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

May 6, 2015

Completion Date

December 17, 2018

Primary Completion Date

November 16, 2018

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gilead Study Director, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02404220

Organization ID

GS-US-339-1560

Secondary IDs

2015-002768-18

Responsible Party

Sponsor

Study Sponsor

Gilead Sciences


Study Sponsor

Gilead Study Director, Study Director, Gilead Sciences


Verification Date

December 2019