Luspatercept for CIA in AML
17. juni 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Guopan Yu, PhD
- Telefonnummer: +8615876559968
- E-post: yugpp@163.com
Studer Kontakt Backup
- Navn: Tianmiao Yu, Master
- E-post: yutm96@163.com
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina
- Rekruttering
- Department of Hematology, Guangdong Second Provincial General Hospital
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Ta kontakt med:
- Guopan Yu, PhD
- Telefonnummer: +8615876559968
- E-post: yugpp@163.com
-
Ta kontakt med:
- Tianmiao Yu, Master
- E-post: yutm96@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time of 50% increase in hemoglobin levels from baseline
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of HGB < 60 G/L during the treatment course (1-28 days)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of people experiencing treatment-related adverse events
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. mai 2027
Datoer for studieregistrering
Først innsendt
6. juni 2026
Først innsendt som oppfylte QC-kriteriene
17. juni 2026
Først lagt ut (Faktiske)
23. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GD2H-2026-483
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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