AZA+Lus VS AZA Monotherapy in HR-MDS
ConditionHigher-risk Myelodysplastic Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
Diagnosed as higher-risk MDS (IPSS intermediate-2/high-risk, or IPSS-R >3.5, or IPSS-M moderate high-, high-, very high-risk)
Untreated patients
Liver and kidney function less than 2 times of upper limit of normal
Disqualifiers
With active infection
Other malignant tumors
Obvious abnormal liver and kidney function, or abnormal function of other organs
Combined with myelofibrosis
Trial design
Design model
Parallel
Treatments tested in this trial
Azacitidine (AZA)
DrugAzacitidine 75mg/m/ day \*5 days, 28 days for 1 course
Luspatercept
DrugLuspatercept 1.0 mg/kg subcutaneously every 3 weeks, adjusted according to hemoglobin, up to 1.75mg/kg. If hemoglobin ≥120g/L, luspatercept can be discontinued.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Azacitidine+LuspaterceptExperimental treatment 2 interventions
Group B: AzacitidineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
overall response rate
Time frame
3 months, 6 monthsSecondary outcomes
1
complete response rate
Time frame
3 months, 6 months2
rate of transfusion independence
Time frame
3 months, 6 months3
adverse event rate
Time frame
through study completion, an average of 1 year4
relapse rate
Time frame
through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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