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Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

NCT00703820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2021-08-10

Study results available
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Summary

The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy-haploidentical NK cell transplantation-in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.

Conditions

Interventions

DRUG

Cytarabine

See Detailed Description

DRUG

Daunorubicin

See Detailed Description

DRUG

Etoposide

See Detailed Description

DRUG

Clofarabine

See Detailed Description

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Rubnitz, MD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-04
Primary Completion
2017-03-30
Completion
2020-08-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00703820 on ClinicalTrials.gov