CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 324 enrolled
Drug / intervention
Cytarabine +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00703820
NCT00703820Phase 3Completed
CompareCT.gov

AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia

St. Jude Children's Research Hospital·interventional·Posted Jun 24, 2008·Updated Aug 10, 2021

In Brief

A Phase 3 clinical trial evaluating Cytarabine, Daunorubicin, and 3 other interventions for Acute Myeloid Leukemia. Completed, enrolled 324 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesSingapore, United States
CollaboratorsGenzyme, a Sanofi Company, National Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2008
Enrollment StartAug 4, 2008
Primary CompletionMar 30, 2017
Study CompletionAug 14, 2020
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 18.0 years ago

Interventions

Cytarabinedrug

See Detailed Description

Daunorubicindrug

See Detailed Description

Etoposidedrug

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Clofarabinedrug

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CliniMACSdevice

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.