About the Clinical Trial

Title

ENCERT: A Phase 1 Trial Using Everolimus in Combination With Nelarabine, Cyclophosphamide and Etoposide in Relapsed T-cell Lymphoblastic Leukemia/Lymphoma

Abstract

For patients with T-cell acute lymphoblastic leukemia (T-ALL) and lymphomas (T-LLy) who relapse, a hematopoietic stem cell transplantation (HSCT) offers the only chance of a cure. Achieving a second remission (CR2) is critical to eligibility for HSCT. The specific aim of this trial is to develop new strategies for reinduction therapy for relapsed T-ALL and T-LLy in order to maximize the benefits of HSCT in CR2. Everolimus was introduced in the late 1990s as an improved formulation of mTOR inhibitor Rapamycin with similar efficacy and improved bioavailability. Nelarabine received accelerated approval for treatment of relapsed T-cell lymphoblastic leukemia/lymphoma in 2005. It was further combined sequentially with etoposide and cyclophosphamide in pediatric patients with refractory T-cell disease. This trial will test the safety—and potential benefit—of everolimus in combination with nelarabine-cyclophosphamide-etoposide chemotherapy in patients with relapsed or refractory T cell lymphoblastic leukemia/lymphoma.

Accrual goal

At the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, we plan to accrue a minimum of six and maximum of 12 patients over the course of two years to participate in this clinical trial. Key inclusion criteria:

• T-ALL in first or greater relapse with at least 5 percent blasts in marrow
• T-ALL with induction failure
• T-LLy with refractory disease
• T-LLy in first or greater relapse with measurable disease
• CNS 1/2 eligible
• Prior therapy with nelarabine alone eligible

Key exclusion criteria:

• Down syndrome
• History of neurological problems
• Existing hypertriglyceridemia
• CNS3 disease
• Prior therapy with nelarabine, etoposide and cyclophosphamide
• Existing ulceration, fistulas, mucosal lesions and skin breakdown

Referrals

For more information about this trial and other trials that may be open, contact the following:

Leann Hassen-Schilling, MPH CCRP
Manager, Clinical Research
Aflac Cancer and Blood Disorders Center
Killian Owen Curing Kids Cancer Clinical Research Office
Children's Healthcare of Atlanta
Phone: 404-785-2025
Email: leann.schilling@choa.org