Secondary Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study of Combination Midostaurin and Decitabine (MIDDAC) in Elderly Patients Newly Diagnosed With Acute Myeloid Leukemia and FLT3 Mutation
This phase II trial studies how well midostaurin and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia and FLT3 mutations. Midostaurin and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the complete response rate for elderly patients with FLT3 mutated acute
myeloid leukemia (AML) using midostaurin and decitabine.
SECONDARY OBJECTIVES:
I. Determine the 1-year overall survival (OS) and progression free survival (PFS) rates.
II. Determine overall response rates in patients treated with this regimen. III. Determine
the complete response duration in patients treated with this regimen.
IV. Assess the safety and toxicity of this regimen based on National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
TERTIARY OBJECTIVES:
I. Assess the prognostic and predictive factors (FLT3 internal tandem duplication [ITD]
versus [vs] tyrosine kinase domain [TKD] mutation) for patients treated with this regimen.
II. Explore genetic targets for this disease.
OUTLINE:
Patients receive decitabine intravenously (IV) over 1 hour on days 1-5 and midostaurin orally
(PO) twice daily (BID) on days 8-21 of courses 1 and 2, and on days 1-28 of each subsequent
course. Patients failing to achieve complete response (CR)/complete response with incomplete
recovery (CRi)/partial response (PR)/morphologic leukemia-free state by end of course 2
receive midostaurin PO BID on days 1-28. Patients achieving CR/CRi/PR/morphologic
leukemia-free state by end of course 8 may continue on current regimen. Patients failing to
achieve a CR/CRi/PR/ morphologic leukemia-free state in bone marrow blasts by end of course 8
go to event monitoring. Treatment repeats every 28 days for up to 18 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 2
years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02890329 -
Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia
|
Phase 1 | |
| Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
| Recruiting |
NCT05513131 -
Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML
|
Phase 2 | |
| Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
| Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
| Completed |
NCT00096122 -
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT00052520 -
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
|
Phase 1/Phase 2 | |
| Terminated |
NCT00049582 -
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
|
Phase 1 | |
| Terminated |
NCT00052598 -
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
| Completed |
NCT01798901 -
AR-42 and Decitabine in Treating Patients With Acute Myeloid Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT01627041 -
Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia
|
Phase 2 | |
| Terminated |
NCT01876953 -
Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT02583893 -
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
|
Phase 2 | |
| Withdrawn |
NCT03365661 -
QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML
|
Phase 2 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT04146038 -
Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease
|
Phase 2 | |
| Completed |
NCT02809222 -
Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls
|
N/A |