Clinical trial · Interventional
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia
Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Aclarubicin in Patients With Refractory/Relapsed Acute Myeloid Leukemia: a Phase 2 Clinical Trial
- 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)
The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapse Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aclarubicin | Drug | — | UNRESOLVED |
| Cladribine | Drug | Cladribine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- The patients in this arm will receive C-CAG regimen for salvage treatment,detailed as following: Cladribine 5mg/㎡，d1-5；G-CSF 300ug,d0-9; aclarubicin 10mg,d3-6;cytarabine 10mg/㎡ q12h, SC, d3-9;4 weeks a cycle
- interventionNames
- Drug: Cladribine
- Drug: G-CSF
- Drug: Aclarubicin
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Complete Remission (CR) rate
- timeFrame
- Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-CAG treatment)
- description
- Less than 5% of blast cells in bone marrow aspiration is defined as CR.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women; * Clinical diagnosis of Relapsed/Refractory AML (non-APL); * ECOG performance status (PS) score 0-3; * AST and ALT \<=2.5 times the institutional ULN; * Total bilirubin \<=2.0 times the institutional ULN * Serum creatinine\<2.0 times the institutional ULN; * Subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects; * Patients should understand the disease and voluntarily receive the study regimen and follow-up. Exclusion Criteria: * Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN); * Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; * Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; * Subjects suffered from AIDS，active hepatitis B or C virus infection; 垫·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; * Be allergic to any component of C-CAG regimen; * Subjects ever exposed to cladribine or CAG-based regimen.
References
Publications (0)
Data not yet available