This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .
The Primary objective is to determine the maximal tolerated dose and Recommended Phase 2 Dose of plerixafor when used in combination with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine during induction therapy Then determine the tolerability of plerixafor administered in combination with G-CSF and cytarabine during consolidation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Induction phase Plerixafor IV from D1 to D3 and from D8 to D10, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D10, Intravenous daunorubicin 60 mg/m2/day from D1 to D3 Cytarabine 500 mg/m2/day continuous infusion over 24h from D1 to D3 followed by cytarabine 2-hour bolus of 1000 mg/m2/12h from D8 to D10. Consolidation phase Plerixafor at D1, D3 and D5, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D5, Cytarabine continuous infusion of 3-h bolus of 3000 mg/m2/12h D1, D3 and D5
Xavier THOMAS
Lyon, France
maximal tolerated dose
4 steps of plerixafor doses from 240 to 480 microgram per kilogram per day concomitant with granulocyte-colony stimulating factor and chemotherapy Three to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
Time frame: 40 days
safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy
Number of Adverse Events and Serious Adverse Events :examined at each dose level by the Independent Data safety Monitoring Board
Time frame: 9 months
Efficacy of plerixafor on leukemic blasts
study of the drop of leukemic blasts blood rate
Time frame: 10 Days
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-Minimal Residual Disease level after first consolidation
Time frame: 2 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
\- Time to remission
Time frame: 5 weeks
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-Rate of patients able to proceed to hematopoietic stel cell transplantation
Time frame: 3 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-disease free survival
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Time frame: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
-event free survival
Time frame: 9 months
Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine
overal survival
Time frame: 9 months