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A Phase 1 Trial using Everolimus in Combination with Nelarabine, Cyclophosphamide and Etoposide in Relapsed T cell Lymphoblastic Leukemia / Lymphoma

Cancer Type
Trial Phase
Phase I
2 - 29 Years, Male and Female
Study Type
Protocol IDs
AflacLL1602 (primary)
Study Sponsor
Children's Healthcare of Atlanta - Egleston


This pilot phase I trial studies the side effects and best dose of everolimus and to see how well it works when given together with nelarabine, cyclophosphamide, and etoposide phosphate in treating patients with T cell lymphoblastic leukemia or lymphoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as everolimus, nelarabine, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


I. To determine the maximum tolerated dose (MTD) and describe the dose-limiting toxicity (DLT) of everolimus when given in combination with nelarabine, etoposide phosphate (etoposide) and cyclophosphamide to children with bone marrow relapse of T cell acute lymphoblastic leukemia (T-ALL) or relapsed T cell lymphoblastic lymphoma (T-LL).

I. To determine the pharmacokinetics of everolimus when given in combination with nelarabine, cyclophosphamide and etoposide.
II. To describe changes in phosphoprotein (pAkt and p4EBP1) and Mer expression at time points pre- and post everolimus therapy in peripheral blood mono-nuclear cells (PBMCs) and bone marrow.
III. To determine the response rate as defined by the ability to achieve complete remission (CR) after 1 and 2 courses of this therapy in children with bone marrow relapse of T-ALL or relapsed T cell lymphoblastic lymphoma (T-LLy).
IV. For patients that proceed to allogeneic stem cell transplantation, to determine the time from start of study treatment to transplant in patients with bone marrow relapse of T-ALL or relapsed T-LLy.

OUTLINE: This is a dose-escalation study of everolimus.

Patients receive everolimus orally (PO) once daily (QD) on days 1-28, nelarabine intravenously (IV) over 60 minutes on days 1-5, etoposide phosphate IV over 1 hour on days 1-5, and cyclophosphamide IV over 30-60 minutes on days 1-5. Patients may also receive methotrexate intrathecally (IT), therapeutic hydrocortisone IT, and cytarabine IT between days 29-36. Patients with stable disease or with partial/complete response after course 1 may receive a second course.
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