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A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

NCT02518113•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
•T-ALL or T-LBL participants with relapsed/refractory disease.
•Have had at least 60 days between prior hematopoietic stem cell transplantation (SCT) and first dose of study drug.
•Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale for adults.
•Lansky score \>50% for participants \<16 years old.
•Have adequate organ function.
•Are at least:
•* adult Phase 1 Part A and Phase 2: ≥16 years old at the time of screening
•* pediatric Phase 1 Part B: 2 to \<16 years old
•Men and women with reproductive potential: Must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer.
+2 more criteria

Exclusion Criteria

•Have previously completed or withdrawn from this study or any other study investigating LY3039478 or other Notch inhibitors.
•Have evidence of uncontrolled, active infection \<7 days prior to administration of study medication.
•Have current or recent gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
•Have active leukemic involvement of the central nervous system (CNS).

Locations (22)

City of Hope National Medical Center

Duarte, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

University of Texas MD Anderson

Houston, Texas, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Lille, France

Nantes, France

Paris, France

Key Dates

Start Date

October 1, 2015

Primary Completion Date

January 15, 2018

Completion Date

January 15, 2018

Last Updated

September 11, 2019

Enrollment

ACTUAL participants

Conditions

T-cell Acute Lymphoblastic LeukemiaT-cell Lymphoblastic Lymphoma

Interventions

LY3039478

DRUG

Dexamethasone

DRUG

Placebo

DRUG

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

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

View study

RECRUITINGPHASE1

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

NCT05679895

T-cell Acute Lymphoblastic LeukemiaLymphoblastic T-Cell Lymphoma

View study

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: September 11, 2019Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL

Inclusion Criteria

Exclusion Criteria

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

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

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