Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT00186875 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-07-28

Study results available
· View outcomes & findings →

Summary

The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are.

Primary Objectives:

* To estimate the response rate for patients with refractory or relapsed ALL.
* To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.

Conditions

Interventions

DRUG

Etoposide, cytarabine, vincristine, dexamethasone

See Detailed Description section for details of treatment interventions.

DRUG

methotrexate, teniposide, PEG-asparaginase

See Detailed Description section for details of treatment interventions.

DRUG

mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine

See Detailed Description section for details of treatment interventions.

DRUG

L-asparaginase, erwinia asparaginase

See Detailed Description section for details of treatment interventions.

PROCEDURE

chemotherapy, intrathecal chemotherapy, steroid therapy

See Detailed Description section for details of treatment interventions.

PROCEDURE

Hematopoietic Stem Cell Transplant

See Detailed Description section for details of treatment interventions.

PROCEDURE

Natural Killer (NK) Cell Transplant

See Detailed Description section for details of treatment interventions.

Sponsors & Collaborators

Principal Investigators

  • Sima Jeha, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2016-08-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00186875 on ClinicalTrials.gov