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Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia

NCT01230788 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2014-12-01

Study results available
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Summary

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.

Conditions

Interventions

DRUG

rituximab

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)).

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Todd Cooper, DO · Emory University/Children's Healthcare of Atlanta

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230788 on ClinicalTrials.gov