drugset / Trial / NCT03318419
Cladribine in Combination With GAP in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL.Our previous experience has shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) 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 Pegaspargase (C-GAP) in patients with refractory/relapsed acute Lymphoblastic Leukemia
Timeline
- Start
- 2016-01-01
- Primary completion
- 2019-12-31
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 5 mg/m2 | — |
| Background | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Background | G-CSF | Unknown | 300 ug | — |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 iu | Intramuscular |