Phase II Study of Hyper-CVAD plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
The goal of this clinical research study is to learn the effectiveness of intensive chemotherapy given in combination with nelarabine (followed by maintenance therapy) in the treatment of patients with T cel ALL and T cell lymphoblastic lymphoma. The safety of this treatment will also be studied.
Disease Group: Leukemia
Treatment Agent: Adriamycin
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: Minimum of 21 days during the first course, and at least 5 days during the ;second course.
Return Visit: Every one to 3 months as long as receiving active therapy. Thereafter every 3 to 6 months as long as on study.
Home Care: All chemotherapy (except course 1 and drug administration phase of course 2) ;and follow up may be provided for at home
1. To determine the complete remission (CR) rate and progression-free survival following treatment with hyper-CVAD in combination with nelarabine in previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma. 2. To determine the safety and overall survival of previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma.
IRB Review and Approval Date: 08/22/2006
Recruitment Status: Open
Projected Accrual: N/A
1) Previously untreated T cell ALL including T cell lymphoblastic
lymphoma. Failure to one induction course of chemotherapy are eligible.
Patients in CR after </= 2 courses are also eligible.
2) ECOG performance status less than or equal to 3.
3) Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable. SGOT or SGPT less than or equal to 4 x ULN.
4) Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable.
1) Pregnant or nursing womenFor Enrollment: