Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02403310
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2015-03-26
Brief Title:
A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase 1 Investigator Sponsored Study of Selinexor in Combination With Daunorubicin and Cytarabine in Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine The maximal tolerated dose MTD of selinexor with daunorubicin and cytarabine will also be established
Detailed Description:
Induction Therapy - Dose escalation of selinexor with Daunorubicin and cytarabine at fixed doses
Consolidation Phase - Patients who are in complete remission CR or complete remission with incomplete count recovery CRi by day 70 and have recovered from any previous non- hematologic toxicity to baseline or grade 1 by day 70 following induction chemotherapy may go on to receive consolidation therapy for up to 2 cycles The consolidation treatment phase will include up to two courses of therapy 28 day cycles as follows
Daunorubicin 45mgm2day days 1-2 Cytarabine 100mgm2day continuous infusion on days 1-5 Selinexor same dose as induction days 13810 unless dose limiting toxicity DLT dictates a dose reduction Selinexor will be given 2 hours prior to daunorubicin on day 1
A second cycle of consolidation therapy using the same doses as above will be administered at the investigators discretion between 28 and 42 days following initiation of the first consolidation treatment after peripheral blood counts have recovered to CR CRi levels and after recovery from any non-hematologic toxicity to baseline or grade 1 Dose escalation of Selinexor will not occur during the consolidation phase
Maintenance Phase - Patients who remain in CR CRi after up to 2 cycles of consolidation and are not eligible for allogeneic stem cell transplant will be eligible for the maintenance phase of treatment after recovery from any previous non-hematologic toxicity to baseline or grade 1 Maintenance therapy will consist of
Selinexor at the same dose as induction on days 1 and 8 of a 21 day cycle They will continue for a maximum of 12 months
Expansion Phase - Once the MTD has been established there will be an expansion phase to enroll an additional 13 subjects at the MTD to better characterize the safety profile and tolerability
Consolidation Phase - Patients who are in complete remission CR or complete remission with incomplete count recovery CRi by day 70 and have recovered from any previous non- hematologic toxicity to baseline or grade 1 by day 70 following induction chemotherapy may go on to receive consolidation therapy for up to 2 cycles The consolidation treatment phase will include up to two courses of therapy 28 day cycles as follows
Daunorubicin 45mgm2day days 1-2 Cytarabine 100mgm2day continuous infusion on days 1-5 Selinexor same dose as induction days 13810 unless dose limiting toxicity DLT dictates a dose reduction Selinexor will be given 2 hours prior to daunorubicin on day 1
A second cycle of consolidation therapy using the same doses as above will be administered at the investigators discretion between 28 and 42 days following initiation of the first consolidation treatment after peripheral blood counts have recovered to CR CRi levels and after recovery from any non-hematologic toxicity to baseline or grade 1 Dose escalation of Selinexor will not occur during the consolidation phase
Maintenance Phase - Patients who remain in CR CRi after up to 2 cycles of consolidation and are not eligible for allogeneic stem cell transplant will be eligible for the maintenance phase of treatment after recovery from any previous non-hematologic toxicity to baseline or grade 1 Maintenance therapy will consist of
Selinexor at the same dose as induction on days 1 and 8 of a 21 day cycle They will continue for a maximum of 12 months
Expansion Phase - Once the MTD has been established there will be an expansion phase to enroll an additional 13 subjects at the MTD to better characterize the safety profile and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None