Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

STATUS

Recruiting
participants needed

320
sponsor

Fujian Medical University

Send

Updated on 19 February 2024

See if I qualify

remission

heart failure

ejection fraction

cytarabine

idarubicin

induction chemotherapy

anthracyclines

myocardial infarction

arrhythmia

leukemia

acute promyelocytic leukemia

infarction

Summary

This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.

Details

Condition	AML in Remission
Age	60years - 75years
Treatment	Idarubicin, ID cytarabine
Clinical Study Identifier	NCT04216771
Sponsor	Fujian Medical University
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy
	Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
	No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) < 50%
	Age 60 years and < 75 years
	ECOG performance status 2
	Written informed consent
	No psychological, familial, social, or geographic reason that would compromise clinical follow up
Exclusion Criteria
	Relapsed or refractory AML
	Patients with acute promyelocytic leukemia (APL)
	Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
	Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
	Subjects for which allogeneic HSCT is planned in CR1
	Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
	Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
	A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

induction chemotherapy

anthracyclines

myocardial infarction

arrhythmia

leukemia

acute promyelocytic leukemia

infarction

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients