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Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

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)

NCT02404220•Gilead Sciences

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (13)

City of Hope

Duarte, California, United States

UCLA

Los Angeles, California, United States

UC Irvine Medical Center

Orange, California, United States

University of California San Diego (UCSD)

San Diego, California, United States

University of Chicago

Chicago, Illinois, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan-Kettering

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Bon Secour St. Francis Hospital

Greenville, South Carolina, United States

University of WA

Seattle, Washington, United States

Key Dates

Start Date

May 6, 2015

Primary Completion Date

November 16, 2018

Completion Date

December 17, 2018

Last Updated

January 2, 2020

Enrollment

ACTUAL participants

Conditions

Acute Lymphoblastic Leukemia

Interventions

Entospletinib

DRUG

Vincristine

DRUG

Dexamethasone

DRUG

CNS Prophylaxis

DRUG

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)