RECRUITING

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

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Conditions

GliomaBrain tumorCentral nervous system (CNS) tumorSpinal cord tumorCyclin-dependent kinase (CDK) 4/6 inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

Official Title

A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy

Quick Facts

Study Start:2024-10-25
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including:
  2. * Anaplastic astrocytoma
  3. * Anaplastic ganglioglioma
  4. * Anaplastic oligodendroglioma.
  5. * Anaplastic pleomorphic xanthoastrocytoma,
  6. * Glioblastoma
  7. * Non-pontine diffuse midline glioma, H3 K27-altered,
  8. * Diffuse hemispheric glioma, H3 G34-mutant
  9. * Diffuse pediatric HGG, H3/IDH-wildtype
  10. * Infant-type hemispheric glioma
  11. * High-grade astrocytoma with piloid features
  12. * High-grade pleomorphic xanthoastrocytoma
  13. * IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion,
  14. * IDH-mutant and 1p/19q co-deleted oligodendroglioma
  15. * IDH-mutant astrocytoma with homozygous CDKN2A/B deletion
  16. * Contraceptive use should be consistent with local regulations for participants in clinical studies.
  17. * Radiotherapy initiated within 6 weeks (+1 week) of diagnosis and administered over 6 weeks (±1 week). Participants \<3 years of age, considered not suitable for radiotherapy may be eligible.
  18. * Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1).
  19. * Maximum of 8 weeks between completion of radiation and C1D1. Exceptional circumstances can be discussed with the medical monitor.
  20. * Acute effects of prior therapies must be Grade ≤1 unless deemed clinically insignificant by the investigator.
  21. * Adequate hematologic and organ function ≤7 days prior to C1D1
  22. * Life expectancy of ≥8 weeks and deemed likely to complete at least 1 cycle of treatment.
  23. * A performance score of ≥60 using:
  24. 1. Lansky scale for participants \<16 years
  25. 2. Karnofsky scale for participants ≥16 years
  26. * Able to swallow and/or have a gastric/nasogastric tube.
  27. * Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D1.
  28. * Able and willing to adhere to study procedures, including frequent blood draws and MRI.
  29. * At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury.
  30. * Has a body surface area (BSA) of ≥0.2 m2.
  1. * Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons.
  2. * Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy.
  3. * Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy.
  4. * Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator.
  5. * Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide).
  6. * Current enrollment in another trial deemed incompatible with this study.
  7. * Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer).
  8. * Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results.
  9. * A preexisting medical condition(s) that, per the investigator, would preclude study participation.
  10. * Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1.
  11. * Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome to temozolomide, and/or abemaciclib, their excipients, or dacarbazine.
  12. * Received a live virus vaccine within 28 days of C1D1.
  13. * Pregnant, breastfeeding, or intend to become pregnant during the study.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
317-615-4559
ClinicalTrials.gov@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
CONTACT

Principal Investigator

Contact Lilly at 1-800-LillyRx (1-800-545-5979)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304
United States
Childrens National Medical Center
Washington, District of Columbia, 20010
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Indiana University Health Hospital
Indianapolis, Indiana, 46202
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109-5861
United States
Spectrum Health
Grand Rapids, Michigan, 49503
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Health
Dallas, Texas, 75235
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Mays Cancer Center
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-25
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-10-25
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Brain tumor
  • Central nervous system (CNS) tumor
  • Spinal cord tumor
  • Cyclin-dependent kinase (CDK) 4/6 inhibitor

Additional Relevant MeSH Terms

  • Glioma