Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia

Part of paid clinical trials in Atlanta, Georgia.

Sponsor: Emory University
Study ID: NCT01230788
Status: Terminated

Conditions

Eligibility Criteria

Sex: ALL
Age: 1 Year - 30 Years
Healthy Volunteers: Not accepted

Interventions

rituximab — DRUG
375 mg/m2/dose on days 8, 15, 22, and 29 (diluted in NS to a final concentration of 1 mg/ml for ease of administration). (Premedicate with Acetaminophen 15 mg/kg po (max 650 mg) and Diphenhydramine 1 mg/kg IV/PO (max 50 mg)).

Study Details

This is a pilot study of a drug called rituximab used together with other drugs-prednisone, etoposide, and ifosfamide. Prednisone, etoposide, and ifosfamide have been used as part of standard chemotherapy for relapsed Acute Lymphoblastic Leukemia (ALL). Rituximab was approved by the Food and Drug Administration in 1997. However, the use of rituximab with prednisone, etoposide, and ifosfamide in pediatric patients with relapsed or refractory ALL is considered experimental. This study is for patients who have ALL in second or greater relapse, or in first relapse and not responding to treatment. The goals of this study are: * To see if using rituximab with prednisone, etoposide, and ifosfamide is beneficial to leukemia treatment * To find out what side effects this combination of drugs can cause A total of 15 participants (30 years old or younger) will be enrolled, over a period of 2 years.