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A Study for Patients With Acute Leukemia | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study for Patients With Acute Leukemia

Phase 1 Study of LY2523355 in Patients With Acute Leukemia

NCT01214655•Eli Lilly and Company

Summary

This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Dose escalation period for both schedules:
•Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and for whom experimental Phase 1 therapy is appropriate.
•Are greater than or equal to 18 years of age.
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
•Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.
•Dose confirmation period for both schedules:
•Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
•Are greater than or equal to 60 years of age.
•Have a performance status of 0 or 1 on the ECOG scale.
•Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.

Exclusion Criteria

•Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
•Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
•Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry.
•Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
•Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant.
•Have uncontrolled systemic infection.
•Females who are pregnant or lactating.
•Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).

Locations (5)

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

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

May 13, 2019

Enrollment

ACTUAL participants

Conditions

Acute Leukemia

Interventions

LY2523355

DRUG

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

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RECRUITINGPHASE2

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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: May 13, 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.

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A Study for Patients With Acute Leukemia

Inclusion Criteria

Exclusion Criteria

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

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

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

Venetoclax Basket Trial for High Risk Hematologic Malignancies

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

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia