Clinical trial · Interventional
Luspatercept for CIA in AML
Efficacy and Safety of Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study
NCT07663864CI-TRIAL-00115670recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-inducing Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luspatercept Injectable Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rotesip treatment group
- description
- 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.
- interventionNames
- Drug: Luspatercept Injectable Product
Primary outcomes (1)
- measure
- Time of 50% increase in hemoglobin levels from baseline
- timeFrame
- Days 1-28 post chemotherapy
- description
- The time of hemoglobin levels increasing 50% from baseline
Secondary outcomes (5)
- measure
- Duration of HGB < 60 G/L during the treatment course (1-28 days)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. De novo AML patients; 2. Age ≥ 18 years and ≤ 60 years; 3. AML with ELN2022-low risk 4. Received 1-3 cycles of HDAC consolidation therapy 5. HGB 60-90 G/L 6. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points; 7. Life expectancy ≥ 3 months; 8. Signed informed consent and able to understand and comply with the procedures required by this protocol. Exclusion Criteria: 1. t-AML/sAML 2. Concurrent myelofibrosis 3. Patients unresponsive to red blood cell transfusions 4. Heart function \< grade 2 5. Renal function: creatinine clearance \< 30 ml/min 6. Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal 7. Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment 8. History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization 9. 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 10. History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients 11. Pregnant or breastfeeding women 12. Patients deemed unsuitable for enrollment by the investigators
References
Publications (0)
Data not yet available
No reference posted for this study.