Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-04-30

Brief Summary

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Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

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Detailed Description

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Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.

Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OMEGAVEN - Daunorubicin - Cytarabine

If WBC ≥ 30 G/L, chemotherapy the induction cycle :

* Daunorubicin 60 mg/m²/day IV on D1, D2, and D3
* Cytarabine 200 mg/m²/day D1 to D7
* OMEGAVEN® 2 ml/kg D1 to D9,

If WBC ≤ 30 G/L, OMEGAVEN during 48 hours

Induction cycle :

OMEGAVEN® 2 ml/kg D-2 to D7 Daunorubicin 60 mg/m²/day IV on D1, D2, and D3

\- Cytarabine 200 mg/m²/day IV D1 to D7

bone marrow aspirate at D15: If BM blasts are \> 5% or if second induction course :

* Daunorubicin 35 mg/m²/day IV D17 and D18
* OMEGAVEN® 2 ml/kg
* Cytarabine 1000 mg/m²/12h IV on D17, D18, and D19

For all patients: G-CSF 5 µg/kg/day subcutaneously from D21 to hematopoietic recovery (PMN \> 1 G/L or \> 0.5 G/L during 3 days).

Consolidation will be administered at investigator's discretion

Group Type EXPERIMENTAL