Clinical Trial: Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC
Brief Summary: Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
Detailed Summary:
Sponsor: Therapeutic Advances in Childhood Leukemia Consortium
Current Primary Outcome: To determine the maximum tolerated doses 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. [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine the complete remission rate after 1 and 2 courses of this therapy in children with T-ALL and bone marrow relapse or T-LL. [ Time Frame: 1-3 months ]
- To determine the percent of children with T-ALL and 1st BM relapse that have a complete response after therapy on this study and proceed to stem cell transplantation in complete response within 20 weeks of beginning this regimen. [ Time Frame: 5 months ]
- To determine minimal residual disease (MRD) levels at the end of each course of treatment. [ Time Frame: 60 days ]
- To evaluate the vitamin B12 pathway and metabolites and the potential association of neurotoxicity following nelarabine therapy with alterations in this pathway. [ Time Frame: 3 years ]
- To determine, in a preliminary manner, whether patients with relapsed T-ALL/LL have a distinct signaling signature that distinguishes malignant cells from normal thymocytes. [ Time Frame: 3 years ]
- To evaluate, in a preliminary manner, whether phospho-flow cytometry can be used to predict clinical response to Nelarabine. [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Therapeutic Advances in Childhood Leukemia Consortium
Dates:
Date Received: September 9, 2009
Date Started: June 2010
Date Completion:
Last Updated: November 20, 2015
Last Verified: November 2015