Refractory Acute Leukemia Clinical Trial
Official title:
A Phase I and Pharmacodynamic Trial of Timed Sequential Administration of the Cyclin Dependent Kinase 4/6 Inhibitor PD 0332991 Followed by Cytarabine Plus Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasias
1.1 Primary Objectives
- To determine the feasibility, tolerability, and toxicities of administering the
selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and
Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk
myelodysplasias (MDS), including primary refractory disease
- To determine the direct cytotoxic effects of single agent PD 0332991 on malignant
blasts
- To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential
combination with ara-C and Mitoxantrone
- To determine if the timed sequential combination of PD 0332991 with ara-C and
mitoxantrone can induce clinical responses in adults with relapsed or refractory acute
leukemias and high-risk MDS
1.2 Secondary Objectives:
- To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell
populations in vivo
- To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest
malignant cells in the G 1 phase of cell cycle, followed by synchronized release of
those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced
ara-C cytotoxicity
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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