Ignite Creation Date:
2024-05-06 @ 8:23 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02728050
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2016-03-14
Brief Title:
Filgrastim Cladribine Cytarabine and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Addition of Sorafenib to G-CSF Cladribine Cytarabine and Mitoxantrone G-CLAM in Adults With Newly-Diagnosed Acute Myeloid Leukemia AML Independent of FLT3-ITD Status A Phase 12 Study
Status:
COMPLETED
Status Verified Date:
2023-06
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:
This phase III trial studies the side effects and best dose of filgrastim granulocyte colony-stimulating factor G-CSF cladribine cytarabine and mitoxantrone when given together with sorafenib and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome likely to be more aggressive Drugs used in chemotherapy such as cladribine cytarabine and mitoxantrone work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading Colony-stimulating factors such as filgrastim may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving filgrastim cladribine cytarabine and mitoxantrone together with sorafenib may kill more cancer cells
Detailed Description:
OUTLINE This is a phase I dose-escalation study of mitoxantrone and sorafenib followed by a phase II study
INDUCTION Patients receive mitoxantrone intravenously IV over 60 minutes on days 1-3 and sorafenib orally PO twice daily BID on days 10-19 in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim subcutaneously SC once daily QD on days 0-5 cladribine IV QD over 2 hours on days 1-5 and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity Patients achieving partial remission including MRD positive pos CR CR with incomplete platelet recovery CRp and CR with incomplete count recovery CRi or persistent AML may receive up to 2 cycles of induction therapy per the discretion of the treating physician
POST-REMISSION Patients receive sorafenib PO BID on days 8-27 or 3 days prior to next cycle of treatment whichever occurs first Patients also receive filgrastim subcutaneously SC QD on days 0-5 cladribine IV QD over 2 hours on days 1-5 and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity Patients achieving MRDneg CR may receive up to 4 cycles of post-remission therapy Patients achieving disease response MRDpos CR CRiCRp or persistent disease may receive up to two induction cycles and 1 cycle of post-remission therapy with mitoxantrone omitted in cycle 3 If they then enter MRDneg CR they can proceed with up to a total of 4 cycles of post-remission therapy
MAINTENANCE THERAPY Patients achieving MRDneg CR may receive maintenance therapy of sorafenib PO BID for up to 1 year
After completion of study treatment patients are followed up every 3 months for up to 5 years
INDUCTION Patients receive mitoxantrone intravenously IV over 60 minutes on days 1-3 and sorafenib orally PO twice daily BID on days 10-19 in the absence of disease progression or unacceptable toxicity Patients also receive filgrastim subcutaneously SC once daily QD on days 0-5 cladribine IV QD over 2 hours on days 1-5 and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity Patients achieving partial remission including MRD positive pos CR CR with incomplete platelet recovery CRp and CR with incomplete count recovery CRi or persistent AML may receive up to 2 cycles of induction therapy per the discretion of the treating physician
POST-REMISSION Patients receive sorafenib PO BID on days 8-27 or 3 days prior to next cycle of treatment whichever occurs first Patients also receive filgrastim subcutaneously SC QD on days 0-5 cladribine IV QD over 2 hours on days 1-5 and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity Patients achieving MRDneg CR may receive up to 4 cycles of post-remission therapy Patients achieving disease response MRDpos CR CRiCRp or persistent disease may receive up to two induction cycles and 1 cycle of post-remission therapy with mitoxantrone omitted in cycle 3 If they then enter MRDneg CR they can proceed with up to a total of 4 cycles of post-remission therapy
MAINTENANCE THERAPY Patients achieving MRDneg CR may receive maintenance therapy of sorafenib PO BID for up to 1 year
After completion of study treatment patients are followed up every 3 months for up to 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-00286 | REGISTRY | None | None |
| 9510 | OTHER | None | None |
| P30CA015704 | NIH | None | None |
| RG1016000 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |