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Anti-metabolites

LY2510924 + Idarubicin + Cytarabine for Leukemia

Phase 1
Waitlist Available
Led By Marina Konopleva, MD, PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

The goal of this clinical research study is to learn about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML. LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream, where they are exposed to chemotherapy (in this case, cytarabine and idarubicin). This is an investigational study. LY2510924 is not FDA approved or commercially available. Its use in this study is investigational. Cytarabine and idarubicin are approved to treat certain types of leukemia. Their use in this study in combination with LY2510924 is investigational. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Eligible Conditions
  • Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cytarabine
Secondary study objectives
Cytarabine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LY2510924 + Idarubicin + CytarabineExperimental Treatment3 Interventions
Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. On Day 8, LY2510924 administered after bone marrow aspiration and/or biopsy is performed. Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase. Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients \> 60 years of age Idarubicin given for 2 days. Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days. Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age \< 60 years). In patients \> 60 years of age Cytarabine given for 3 days only. Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY2510924
2016
Completed Phase 2
~130
Cytarabine
FDA approved
Idarubicin
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,048 Previous Clinical Trials
1,800,044 Total Patients Enrolled
463 Trials studying Leukemia
31,851 Patients Enrolled for Leukemia
Eli Lilly and CompanyIndustry Sponsor
2,651 Previous Clinical Trials
3,224,431 Total Patients Enrolled
17 Trials studying Leukemia
3,816 Patients Enrolled for Leukemia
High Impact Clinical Research Support ProgramOTHER
2 Previous Clinical Trials
92 Total Patients Enrolled
~4 spots leftby Oct 2025
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