Clinical trial comparing azacytidine (Vidaza®) versus fludarabine plus cytarabine in elderly patients with newly diagnosed acute myeloid leukemia

Phase 1

• Conditions: ewly diagnosed acute myeloid leukemia.; MedDRA version: 17.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-000319-15-ES
• Lead Sponsor: Fundación PETHEMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

1 - Having voluntarily given informed consent before performing any test that is not part of routine care of patients.
2 - Age greater than or equal to 65.
3 - Morphological diagnosis of non-promyelocytic AML according to the WHO criteria.
4 - Newly diagnosed AML.
5 - ECOG performance status <4.
6 - Ability and willingness to comply with the schedule of study visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

1 - Genetic diagnosis of acute promyelocytic leukemia.
2 - Patients with AML secondary to myelodysplastic syndrome (MDS) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents (hypomethylating or standard chemotherapy). Treatment with hydroxyurea prior to randomization is allowed.
3 - Serum creatinine ? 250 mmol / l ( ? 2.5 mg/dL ) (unless attributed to AML) .
4 - Bilirubin , alkaline phosphatase or ALT > 5 times the value of the upper limit of normal (unless attributed to AML) .
5 - Presence of an active and/or non controlled pathology different to AML which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study .
6 - Other active concomitant malignancy or whose remission is less than one year from the screening day (except carninoma in situ).
7 - Presence of any psychiatric illness or medical condition that , in the investigator's opinion, prevents the subject participation in the study .
8 - Life expectancy less than X months.
9 - Inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified