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AflacLL1602 ENCERT

Diseases

Patients must have T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma.

Description

T- cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy) has an increase in proteins in a specific pathway called the mTOR pathway within the cancer cells. In cancer cells it can encourage untimely cell growth, cell production, and cell survival. Everolimus is an inhibitor of the mTOR pathway and can decrease the growth and survival of cancer cells. It also prevents communication within cells and stops proteins from being made that may contribute to leukemia. The main purpose of the study is to find the maximum tolerated dose of everolimus when used together with standard chemotherapy.

Eligibility Criteria

  • Ages eligible for study: 2 to 29 years (Child, Adult)
  • Patients with Leukemia:
    • Patients must have relapsed (first or greater relapse) or refractory T-cell acute lymphoblastic leukemia (T-ALL)
  • Patients with Lymphoma:
    • Patients must have relapsed (first or greater relapse) or refractory lymphoma
  • Performance Score Patients must have a Karnofsky ≥ 50% for subjects > 16 years of age and Lansky score ≥ 50 for subjects ≤ 16 years of age
  • Prior Therapy A. Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study.
  • Adequate organ function

Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.

Contact

Eric S. Schafer, MD, MHS
Local Principal Investigator
Texas Children’s Cancer and Hematology Centers