Luspatercept for CIA in AML
17 juni 2026 uppdaterad av: Qing Zhang, Guangdong Second Provincial General Hospital
Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied.
Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy.
The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders.
Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy.
Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Guopan Yu, PhD
- Telefonnummer: +8615876559968
- E-post: yugpp@163.com
Studera Kontakt Backup
- Namn: Tianmiao Yu, Master
- E-post: yutm96@163.com
Studieorter
-
-
Guangdong
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Guangzhou, Guangdong, Kina
- Rekrytering
- Department of Hematology, Guangdong Second Provincial General Hospital
-
Kontakt:
- Guopan Yu, PhD
- Telefonnummer: +8615876559968
- E-post: yugpp@163.com
-
Kontakt:
- Tianmiao Yu, Master
- E-post: yutm96@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- De novo AML patients;
- Age ≥ 18 years and ≤ 60 years;
- AML with ELN2022-low risk
- Received 1-3 cycles of HDAC consolidation therapy
- HGB 60-90 G/L
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- Life expectancy ≥ 3 months;
- Signed informed consent and able to understand and comply with the procedures required by this protocol.
Exclusion Criteria:
- t-AML/sAML
- Concurrent myelofibrosis
- Patients unresponsive to red blood cell transfusions
- Heart function < grade 2
- Renal function: creatinine clearance < 30 ml/min
- Liver function: ALTd > 5 times normal, bilirubin > 3 times normal
- Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
- History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
- History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
- Pregnant or breastfeeding women
- Patients deemed unsuitable for enrollment by the investigators
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Rotesip treatment group
Patients were screened and enrolled in the treatment group to evaluate the efficacy and safety of rotezipeptide in the treatment of chemotherapy-inducing anemia in AML.
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First, 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time of 50% increase in hemoglobin levels from baseline
Tidsram: Days 1-28 post chemotherapy
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The time of hemoglobin levels increasing 50% from baseline
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Days 1-28 post chemotherapy
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Duration of HGB < 60 G/L during the treatment course (1-28 days)
Tidsram: Days 1-28 after AML chemistry treatment
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The duration of HGB < 60 G/L during this consolidation treatment course (days 1-28);
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Days 1-28 after AML chemistry treatment
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Incidence of HGB < 60 G/L during the treatment course (days 1-28)
Tidsram: Days 1-28 after chemotherapy
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The incidence of HGB < 60 G/L during this consolidation treatment course (days 1-28);
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Days 1-28 after chemotherapy
|
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Red blood cell transfusion volume
Tidsram: Days 1-28 after AML chemistry treamtment
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Red blood cell transfusion volume during this consolidation treatment course (days 1-28);
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Days 1-28 after AML chemistry treamtment
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MRD negative rate
Tidsram: 6 months after AML chemistry treamtment
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MRD negative rate within 6 months;
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6 months after AML chemistry treamtment
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Anemia recurrence rate
Tidsram: 12 months after AML chemistry treamtment
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Relapse rate 12 months after chemotherapy;
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12 months after AML chemistry treamtment
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of people experiencing treatment-related adverse events
Tidsram: Days 1-28 after Luspatercept treatment
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According to the CTCAE v5.0 assessment, the number of people who experienced treatment-related adverse events included both hematological and non-hematological toxicities.
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Days 1-28 after Luspatercept treatment
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
31 december 2026
Avslutad studie (Beräknad)
31 maj 2027
Studieregistreringsdatum
Först inskickad
6 juni 2026
Först inskickad som uppfyllde QC-kriterierna
17 juni 2026
Första postat (Faktisk)
23 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GD2H-2026-483
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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