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Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

2014-08-27 03:51:40 | BioPortfolio

Summary

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

Description

First Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1,3,5

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

- Cytarabine 100 mg/m² cont. i.v. days 1-7

- Idarubicin 12 mg/m² i.v. days 1 and 3

- Etoposide 100 mg/m² i.v. days 1-3

- ± ATRA 45 mg/m² p.o. days 6-8

- ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5

- ± ATRA 15 mg/m² p.o. Tag 6-21

- Pegfilgrastim 6 mg s.c day 10

cohort 2 (> ID 336)

- Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3

- ± ATRA 15 mg/m² p.o. Tag 4-21

- Pegfilgrastim 6 mg s.c day 8

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia

Intervention

Cytarabine, Idarubicin, Etoposide, All-trans retinoic acid, Pegfilgrastim

Location

Department of Hematology/Oncology, University Hospital Innsbruck
Innsbruck
Austria
6020

Status

Active, not recruiting

Source

University of Ulm

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:51:40-0400

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Medical and Biotech [MESH] Definitions

A cytochrome P450 enzyme that resides in the ENDOPLASMIC RETICULUM. It catalyzes the conversion of trans-RETINOIC ACID to 4-hydroxyretinoic acid.

Proteins in the nucleus or cytoplasm that specifically bind RETINOIC ACID or RETINOL and trigger changes in the behavior of cells. Retinoic acid receptors, like steroid receptors, are ligand-activated transcription regulators. Several types have been recognized.

Apolipoproteins and lipocalins that occur in HIGH-DENSITY LIPOPROTEINS. They bind or transport lipids in the blood including sphingosine-1-phosphate, MYRISTIC ACID; STEARIC ACIDS; and ALL-TRANS RETINOIC ACID.

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A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

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