Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01253070
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2010-12-02
Brief Title:
Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Incorporating Sorafenib NSC 724772 Into the Therapy of Patients gt 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2022-08
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 II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia AML Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as daunorubicin hydrochloride and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the 1-year overall survival rate of patients age 60 with FLT3-ITD AML treated with a sorafenib sorafenib tosylate containing induction and post-remission therapy is significantly higher than the historical 1-year overall survival rate of similar patients who were not treated with sorafenib
SECONDARY OBJECTIVES
I To determine the rates of complete remission CR CR with incomplete count recovery CRi and cytogenetic complete remission CCyR to induction chemotherapy
II To determine the overall survival event-free survival and remission duration in patients treated on this study
III To describe the frequency and severity of adverse events for patients treated on this study
IV To describe the interaction of pre-treatment disease and patient characteristics including morphology cytogenetics immunophenotype molecular genetic features white blood cell WBC count and hemogram and performance status on clinical outcomes
V To assess FLT3 ligand concentrations and FLT3 plasma inhibitory activity during treatment and determine the relationship to clinical outcomes Cancer and Leukemia Group B CALGB 21003 VI To describe the interaction of FLT3 mutation type tyrosine kinase domain TKD vs ITD and allelic ratio on clinical outcomes CALGB 21003 VII To characterize geriatric assessment measures in the context of a treatment trial for AML defined by the observed distribution and number of missing values for each measurement CALGB 361006 VIII To identify specific geriatric assessment measures which are independently associated with overall survival OS 30-day treatment-related mortality and key quality of life outcomes number of days hospitalized number of oncology clinic visits admission to a nursing facility in patients receiving induction chemotherapy for AML CALGB 361006 IX To explore the impact of induction chemotherapy on physical cognitive psychosocial factors CALGB 361006
OUTLINE
INDUCTION THERAPY Patients receive daunorubicin hydrochloride intravenously IV on days 1-3 cytarabine IV continuously on days 1-7 and sorafenib tosylate orally PO twice daily BID on days 1-7 Patients then undergo a bone marrow aspirate or biopsy on day 14
Patients with persistent disease undergo a second remission induction therapy comprising daunorubicin hydrochloride IV on days 1-2 cytarabine IV continuously on days 1-5 and sorafenib tosylate PO BID on days 1-7 Patients who achieve complete response CR proceed to consolidation therapy
CONSOLIDATION THERAPY Patients receive cytarabine IV over 3 hours on days 1-5 and sorafenib tosylate PO BID on days 1-28 Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity Patients with continued CR proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive sorafenib tosylate PO BID on days 1-28 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
NOTE Patients who achieve CR and who are eligible for hematopoietic stem cell transplant HSCT are encouraged to enroll in Cancer and Leukemia Group B CALGB 100103 Patients in CR who are unable or unwilling to undergo HSCT receive two cycles of remission consolidation therapy
NOTE Patients in CRcomplete remission with incomplete count recovery CRi who are unable or unwilling to complete remission consolidation therapy may proceed directly to maintenance therapy after consulting with the CALGB study chair
After completion of study therapy patients are followed up every 2 months for 2 years every 3 months for 2 years and then yearly for a maximum of 10 years
I To determine if the 1-year overall survival rate of patients age 60 with FLT3-ITD AML treated with a sorafenib sorafenib tosylate containing induction and post-remission therapy is significantly higher than the historical 1-year overall survival rate of similar patients who were not treated with sorafenib
SECONDARY OBJECTIVES
I To determine the rates of complete remission CR CR with incomplete count recovery CRi and cytogenetic complete remission CCyR to induction chemotherapy
II To determine the overall survival event-free survival and remission duration in patients treated on this study
III To describe the frequency and severity of adverse events for patients treated on this study
IV To describe the interaction of pre-treatment disease and patient characteristics including morphology cytogenetics immunophenotype molecular genetic features white blood cell WBC count and hemogram and performance status on clinical outcomes
V To assess FLT3 ligand concentrations and FLT3 plasma inhibitory activity during treatment and determine the relationship to clinical outcomes Cancer and Leukemia Group B CALGB 21003 VI To describe the interaction of FLT3 mutation type tyrosine kinase domain TKD vs ITD and allelic ratio on clinical outcomes CALGB 21003 VII To characterize geriatric assessment measures in the context of a treatment trial for AML defined by the observed distribution and number of missing values for each measurement CALGB 361006 VIII To identify specific geriatric assessment measures which are independently associated with overall survival OS 30-day treatment-related mortality and key quality of life outcomes number of days hospitalized number of oncology clinic visits admission to a nursing facility in patients receiving induction chemotherapy for AML CALGB 361006 IX To explore the impact of induction chemotherapy on physical cognitive psychosocial factors CALGB 361006
OUTLINE
INDUCTION THERAPY Patients receive daunorubicin hydrochloride intravenously IV on days 1-3 cytarabine IV continuously on days 1-7 and sorafenib tosylate orally PO twice daily BID on days 1-7 Patients then undergo a bone marrow aspirate or biopsy on day 14
Patients with persistent disease undergo a second remission induction therapy comprising daunorubicin hydrochloride IV on days 1-2 cytarabine IV continuously on days 1-5 and sorafenib tosylate PO BID on days 1-7 Patients who achieve complete response CR proceed to consolidation therapy
CONSOLIDATION THERAPY Patients receive cytarabine IV over 3 hours on days 1-5 and sorafenib tosylate PO BID on days 1-28 Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity Patients with continued CR proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive sorafenib tosylate PO BID on days 1-28 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity
NOTE Patients who achieve CR and who are eligible for hematopoietic stem cell transplant HSCT are encouraged to enroll in Cancer and Leukemia Group B CALGB 100103 Patients in CR who are unable or unwilling to undergo HSCT receive two cycles of remission consolidation therapy
NOTE Patients in CRcomplete remission with incomplete count recovery CRi who are unable or unwilling to complete remission consolidation therapy may proceed directly to maintenance therapy after consulting with the CALGB study chair
After completion of study therapy patients are followed up every 2 months for 2 years every 3 months for 2 years and then yearly for a maximum of 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |
| NCI-2011-02618 | REGISTRY | None | None |
| CDR0000689593 | None | None | None |
| CALGB-11001 | OTHER | None | None |
| CALGB-11001 | OTHER | None | None |
| U10CA180821 | NIH | None | None |