Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03900949
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2019-04-01
Brief Title:
Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia
Sponsor:
Uma Borate
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Tolerability of Gemtuzumab Ozogamicin and Midostaurin When Used in Combination With Standard Cytarabine and Daunorubicin Induction for Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual goal met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin GO and midostaurin with the standard induction therapy cytarabine and daunorubicin in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia AML GO is FDA approved for the treatment of adults with newly diagnosed CD33 positive AML and used in combination with chemotherapy cytarabine and daunorubicin Midostaurin is FDA approved for use with cytarabine and daunorubicin in patients with FLT3-mutated AML By combining standard induction therapy with GO and midostaurin our aim is to investigate a novel approach to treating patients with newly diagnosed FLT3-mutated AML
Detailed Description:
PRIMARY OBJECTIVE
I To assess the maximum tolerated dose MTD of combining gemtuzumab ozogamicin GO to the induction regimen of cytarabine and daunorubicin DA and midostaurin
SECONDARY OBJECTIVES
I To assess the frequency of early death associated with study treatment II To evaluate the preliminary efficacy of the study treatment III To assess the safety profile of the study treatment
EXPLORATORY OBJECTIVES
I Quantify CD33 expression on acute myeloid leukemia AML blasts II Determine the CD33 single-nucleotide polymorphism SNP status previously reported to correlate with response and correlate clinical outcomes of patients with the CD33 genotype
OUTLINE This is a dose finding study to identify the maximum tolerated dose MTD schedule of GO and its safety and tolerability in combination with midostaurin in FLT3-mutated newly diagnosed AML patients
INDUCTION THERAPY Patients receive cytarabine intravenously IV on days 1-7 daunorubicin IV on days 1-3 and midostaurin 50mg orally PO twice daily BID on days 8-21 Patients also receive gemtuzumab ozogamicin IV either on day or days 1 and 4 or days 1 4 and 7 depending on dose level in the absence of disease progression or unacceptable toxicity
RE-INDUCTION THERAPY Between days 14 and 21 of Induction Therapy patients who achieve at least 5 bone marrow blasts after an optional bone marrow biopsy may receive a single 28-day cycle of cytarabine and daunorubicin with or without midostaurin per the treating physician Patients who achieve a complete remission CR or complete remission with incomplete blood count recovery CRi may undergo allogeneic stem cell transplantation SCT or receive consolidation therapy
CONSOLIDATION THERAPY
PATIENTS 60 YEARS Patients receive high dose cytarabine HiDAC IV on days 1 3 and 5 and gemtuzumab ozogamicin IV on day 1 of cycle 1 and midostaurin 50mg PO BID on days 8-21 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
PATIENTS 60 YEARS Patients receive cytarabine MiDAC IV on days 1 3 and 5 and gemtuzumab ozogamicin IV on day 1 of cycle 1 and midostaurin 50mg PO BID on days 8-21 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 24 months
I To assess the maximum tolerated dose MTD of combining gemtuzumab ozogamicin GO to the induction regimen of cytarabine and daunorubicin DA and midostaurin
SECONDARY OBJECTIVES
I To assess the frequency of early death associated with study treatment II To evaluate the preliminary efficacy of the study treatment III To assess the safety profile of the study treatment
EXPLORATORY OBJECTIVES
I Quantify CD33 expression on acute myeloid leukemia AML blasts II Determine the CD33 single-nucleotide polymorphism SNP status previously reported to correlate with response and correlate clinical outcomes of patients with the CD33 genotype
OUTLINE This is a dose finding study to identify the maximum tolerated dose MTD schedule of GO and its safety and tolerability in combination with midostaurin in FLT3-mutated newly diagnosed AML patients
INDUCTION THERAPY Patients receive cytarabine intravenously IV on days 1-7 daunorubicin IV on days 1-3 and midostaurin 50mg orally PO twice daily BID on days 8-21 Patients also receive gemtuzumab ozogamicin IV either on day or days 1 and 4 or days 1 4 and 7 depending on dose level in the absence of disease progression or unacceptable toxicity
RE-INDUCTION THERAPY Between days 14 and 21 of Induction Therapy patients who achieve at least 5 bone marrow blasts after an optional bone marrow biopsy may receive a single 28-day cycle of cytarabine and daunorubicin with or without midostaurin per the treating physician Patients who achieve a complete remission CR or complete remission with incomplete blood count recovery CRi may undergo allogeneic stem cell transplantation SCT or receive consolidation therapy
CONSOLIDATION THERAPY
PATIENTS 60 YEARS Patients receive high dose cytarabine HiDAC IV on days 1 3 and 5 and gemtuzumab ozogamicin IV on day 1 of cycle 1 and midostaurin 50mg PO BID on days 8-21 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
PATIENTS 60 YEARS Patients receive cytarabine MiDAC IV on days 1 3 and 5 and gemtuzumab ozogamicin IV on day 1 of cycle 1 and midostaurin 50mg PO BID on days 8-21 Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 24 months
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-2019-01726 | REGISTRY | CTRP Clinical Trial Reporting Program | None |