A Phase I Study Investigating the Combination of RAD001 With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of everolimus in combination with standard
remission-induction therapy comprising mitoxantrone hydrochloride, cytarabine, and
etoposide (MICE-regimen) followed by consolidation therapy comprising idarubicin,
cytarabine, and etoposide in older patients with newly diagnosed acute myeloid
leukemia.
Secondary
- To determine the safety profile of this regimen in these patients.
- To determine the anti-leukemic activity (complete remission rate [complete remission
and complete remission with incomplete blood count recovery]) following one or two
induction courses.
OUTLINE: This is a multicenter, dose-escalation study of everolimus.
- Standard remission-induction therapy: Patients receive mitoxantrone hydrochloride IV
over 30 minutes on days 1, 3, and 5; cytarabine IV continuously on days 1-7; etoposide
IV over 1 hour on days 1-3; and oral everolimus once a day on days 1-21. Patients with
partial remission (PR) receive a second induction course, beginning 7-17 days after
completion of induction course 1. Patients with complete remission or complete
remission with incomplete blood count recovery (CR/CRi) after induction therapy proceed
to consolidation therapy; patients who have failed to achieve PR after induction course
1 or a CR/CRi after induction course 2 are removed from study.
- Consolidation therapy: Beginning within 3 weeks from CR/CRi documentation, patients
receive idarubicin IV over 30 minutes on days 1, 3, and 5; cytarabine IV continuously
on days 1-5; etoposide IV over 1 hour on days 1-3; and oral everolimus once a day on
days 1-10. Patients may receive another course of the consolidation therapy, beginning
at least 4 weeks after initiation of consolidation therapy course 1.
After completion of study treatment, patients are followed up once a month for 1 year, every
3 months for 1 year, and then periodically thereafter.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose of everolimus
MTD of RAD given in combination with the MICE regimen
At one year from study entry
Yes
Sergio Amadori, MD
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Italy: Ethics Committee
AML1208
NCT01154439
October 2010
November 2012
Name | Location |
---|