Clinical Trial: A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients
Brief 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).
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome:
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 Days) ]
- Number of Participants who Achieve Complete Remission (CR) or CR with Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR) [ Time Frame: Baseline to Objective Disease Progression (Approximately 2 Months) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of LY3039478 in Combination with Dexamethasone [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (Approximately 4 Weeks) ]
- Number of Participants with CR or CRi and Notch-1 or FBXW7 Mutations [ Time Frame: Baseline to Objective Disease Progression (Approximately 2 Months) ]
- Number of Participants who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR [ Time Frame: Baseline to Objective Disease Progression (Approximately 2 Months) ]
- Number of Participants who Achieve PR [ Time Frame: Baseline to Objective Disease Progression (Approximately 2 Months) ]
- Duration of Remission (DoR) [ Time Frame: Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year) ]
- Relapse Free Survival (RFS) [ Time Frame: Date of CR to Relapse or Death from any Cause (Approximately 1 Year) ]
- Event Free Survival (EFS) [ Time Frame: Baseline to Objective Disease Progression or Death from Any Cause (Approximately 1 Year) ]
- Overall Survival (OS) [ Time Frame: Baseline to the Date of Death from Any Cause (Approximately 1.5 Years) ]
- Change from Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score [ Time Frame: Baseline, End of Study (Approximately 1.5 Years) ]
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: August 5, 2015
Date Started: September 2015
Date Completion: April 2020
Last Updated: April 17, 2017
Last Verified: April 2017