ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome (ENHANCE)

STATUS

Recruiting
End date

Dec 23, 2026
participants needed

520
sponsor

Gilead Sciences

Updated on 23 October 2022

See if I qualify

remission

azacitidine

high risk myelodysplastic syndrome

Summary

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Details

Condition	Myelodysplastic Syndromes
Treatment	Placebo, Azacitidine, Magrolimab
Clinical Study Identifier	NCT04313881
Sponsor	Gilead Sciences
Last Modified on	23 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk
	Adequate performance status and hematological, liver, and kidney function
Exclusion Criteria
	Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor
	Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents
	Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R
	Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year
	Contraindications to azacitidine
	Clinical suspicion of active central nervous system (CNS) involvement by MDS
	Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history
	Pregnancy or active breastfeeding
	Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening
	Note: Other protocol defined Inclusion/Exclusion criteria may apply

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

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

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

remission

azacitidine

high risk myelodysplastic syndrome

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.

ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome (ENHANCE)