Clinical trial · Interventional
Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
NCT06265545CI-TRIAL-00121081recruitingN/AClinicalTrials.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)
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Refractory | — | UNRESOLVED | — |
| Relapsed | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin/ Idarubicin /Mitoxantrone | Drug | — | UNRESOLVED |
| Gilteritinib | Drug | Gilteritinib | ALIAS |
| Homoharringtonine | Drug | Omacetaxine Mepesuccinate | ALIAS |
| Ivosidenib | Drug | Ivosidenib | ALIAS |
| Lisaftoclax | Drug | — | UNRESOLVED |
| PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others | Drug | — |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- With IDH1 gene mutation(up to 2 cycles available):IVA : Ivosidenib 500mg d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax100mg d1, 200mg d2, 400mg d3, 800mg d4-14, d14-28(If the proportion of bone marrow blasts on day 14 is greater than 5% )
- interventionNames
- Drug: Ivosidenib
- Drug: Venetoclax
- Drug: Azacitidine
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- FLT3/ITD or FLT3/TKD gene mutation (up to 2 cycles available) GVA: Gilteritinib 80mg, d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-14, 400mg d14-28 (if the proportion of bone marrow blasts on day 14 are greater than 5%)
- interventionNames
- Drug: Venetoclax
- Drug: Gilteritinib
- Drug: Azacitidine
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 1\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria). 2\. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia. 3\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family. Exclusion Criteria: 1. Concurrent malignant tumors of other organs (patients requiring treatment). 2. Participants considered unsuitable for inclusion by the researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.