drugset / Trial / NCT03792256
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
NaSingle-groupOpen-labelTreatment
Summary
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.
Timeline
- Start
- 2019-04-11
- Primary completion
- 2021-06-30
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 50 mg/m2 | Oral |
| Background | Cytarabine | Small molecule | — | Intrathecal |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 iu | Intravenous |
| Background | Prednisolone | Other / unclassified | 40 mg/m2 | Oral |
| Background | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | Intravenous |