NECTAR: Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide) in T-ALL Relapse: A Joint Study of TACL and POETIC

Categories:

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Leukemia

Eligibility Overview:

  • Patients must be ≥ 1 and ≤ 21 years of age at the time of study enrollment.
  • Patients must have first relapse T-cell ALL or T-cell lymphoblastic lymphoma.
  • Patients with T-cell ALL must have greater than 25% blasts in the bone marrow with or without extramedullary disease.
  • Patients with T-cell ALL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis.

Description

This is a research study for patients who have relapsed T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL). Relapse means the leukemia or lymphoma has come back after treatment. Nelarabine is a drug approved by the FDA (Food and Drug Administration) for treating children and adults with T-ALL and T-LL. This research study will use nelarabine with two other cancer fighting drugs. Nelarabine (Arranon®) will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Nelarabine has been used by itself to treat children and adults with relapsed T-ALL and T-LL. Nelarabine has not been tested in combination with the other chemotherapy drugs used in this study. This is a Phase I study. In a phase I study drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the doses of nelarabine, etoposide and cyclophosphamide that can be safely given for 5 days.

Objectives

  • To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
  • To determine the second complete remission (CR2) rate after 1 and 2 courses of this therapy in children with T-ALL and bone marrow relapse or T-LL.
  • To determine the percentage of children with T-ALL and 1st BM relapse that attain CR2 following nelarabine, etoposide and cyclophosphamide and are able to proceed to hematopoietic stem cell transplantation (HSCT) in CR2 within 20 weeks of beginning re-induction chemotherapy.
  • To determine minimal residual disease (MRD) levels at the end of each course of therapy.

Eligibility

  • Patients must be ≥1 and ≤ 21 years of age at the time of study enrollment.
  • Patients must have first relapse T-cell ALL or T-cell lymphoblastic lymphoma.
  • Patients with T-cell ALL must have greater than 25% blasts in the bone marrow with or without extramedullary disease.
  • Patients with T-cell ALL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).

Contact

Sima Jeha, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.