Luspatercept for CIA in AML
ConditionChemotherapy-inducing Anemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGuangdong Second Provincial General Hospital
About this trial
This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
De novo AML patients;
Age ≥ 18 years and ≤ 60 years;
AML with ELN2022-low risk
Received 1-3 cycles of HDAC consolidation therapy
Disqualifiers
t-AML/sAML
Concurrent myelofibrosis
Patients unresponsive to red blood cell transfusions
Heart function < grade 2
Trial design
Design model
Single group
Treatments tested in this trial
Luspatercept Injectable Product
DrugFirst, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Rotesip treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time of 50% increase in hemoglobin levels from baseline
The time of hemoglobin levels increasing 50% from baseline
Time frame
Days 1-28 post chemotherapySecondary outcomes
1
Duration of HGB < 60 G/L during the treatment course (1-28 days)
The duration of HGB \< 60 G/L during this consolidation treatment course (days 1-28);
Time frame
Days 1-28 after AML chemistry treatment2
Incidence of HGB < 60 G/L during the treatment course (days 1-28)
The incidence of HGB \< 60 G/L during this consolidation treatment course (days 1-28);
Time frame
Days 1-28 after chemotherapy3
Red blood cell transfusion volume
Red blood cell transfusion volume during this consolidation treatment course (days 1-28);
Time frame
Days 1-28 after AML chemistry treamtment4
MRD negative rate
MRD negative rate within 6 months;
Time frame
6 months after AML chemistry treamtmentOther outcomes
1
Number of people experiencing treatment-related adverse events
According to the CTCAE v5.0 assessment, the number of people who experienced treatment-related adverse events included both hematological and non-hematological toxicities.
Time frame
Days 1-28 after Luspatercept treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Second Provincial General Hospital
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Guangzhou First People's Hospital
Collaborator
Affiliated Hospital of Guangdong Medical University
Collaborator
Guangzhou 8th People's Hospital
Collaborator
Source ClinicalTrials.gov