Timed-Sequential Induction in CBF-AML

Plain-language summary

This study looks at giving chemotherapy drugs (daunorubicine-cytarabine) in a timed, sequential way in a subtype of acute myeloid leukemia known as CBF-AML. Patients aged 18 to 60 with newly diagnosed CBF-AML were able to take part. Sponsored by Assistance Publique - Hôpitaux de Paris, the study was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

Assistance Publique - Hôpitaux de Paris

Intervention

Chemotherapy (DAUNORUBICINE-CYTARABINE), Chemotherapy (DAUNORUBICINE-CYTARABINE)

Start date

7/1/2007

Estimated completion

6/1/2011

Countries

France

Related genes

Locations

• Nîmes, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Patients aged 18-60 years.
* With a newly-diagnosed de novo or therapy-related CBF-AML defined

Exclusion Criteria:

* No previously treated with any anti-leukemic agent.
* No presenting any diagnosis of uncontrolled or metastatic tumor.
* OMS performance status \< 2,
* Absence of uncontrolled severe infection,
* AST and ALT 2.5 x ULN,
* Total bilirubin 1.5 x ULN,
* Serum creatinine 1.5 x ULN