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MRC AML-HR: Chemo +/- Filgrastim/Tretinoin in High-Risk AML

NCT00005863Phase 3

Key facts

Status: Completed
Start: Aug 1998
Countries: 1
Sponsor: Medical Research Council
Modality: Cytokines & Interferons, Small Molecules

Drugs: tretinoinfilgrastim
Conditions: acute myeloid leukemia (AML)

Overview

Phase 3, randomised, open-label trial of tretinoin and filgrastim in acute myeloid leukemia (AML) (8 arms), sponsored by Medical Research Council. Primary endpoints: Achievement of Remission, Overall Survival and 1 more. Started Aug 1998; status: completed.

Design

8 arms

Study design: RandomizedOpen-label

ADE + G-CSF + ATRA
ADE Chemo + Filgrastim + Tretinoin
ADE + G-CSF
ADE Chemo + Filgrastim
ADE + ATRA
ADE Chemo + Tretinoin
ADE Alone
ADE Chemo only
FLAG + G-CSF + ATRA
FLAG Chemo + Filgrastim + Tretinoin
FLAG + G-CSF
FLAG Chemo + Filgrastim

2 more in the full profile.

Who it enrols

Patients with high-risk AML (resistant, refractory, relapsed, or adverse cytogenetics) of any age, excluding APL and CML blast crisis.

Endpoints

Primary

Achievement of Remission
Overall Survival
Duration of Remission

Secondary

Toxicity
Quality of Life3 months

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