Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504459
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study of Venetoclax ABT-199 in Combination With Cladribine and Low-Dose Cytarabine Alternating With Azacitidine Plus Venetoclax in Newly Diagnosed Monocytic AML and Active-Signaling Mutated AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia AML and active signaling mutated AML Venetoclax is in a class of medications called B-cell lymphoma-2 BCL-2 inhibitors It may stop the growth of cancer cells by blocking BCL-2 a protein needed for cancer cell survival Chemotherapy drugs such as cladribine cytarabine and azacitidine 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 Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML
Detailed Description:
PRIMARY OBJECTIVE
I Assess efficacy of the investigational treatment based on disease remission
SECONDARY OBJECTIVES
I Assess efficacy of the investigational treatment based on clinical response II Assess any-cause survival after treatment III Assess survival in the absence of treatment failure hematologic relapse or progressive disease
IV Assess duration of response based on morphological assessments V Assess the safety and tolerability of the regimen
EXPLORATORY OBJECTIVES
I Assess response based on measurable residual disease MRD II Identify markers of clonal or clinical response and resistance to treatment
III Assess participant quality of life QoL using Patient Reported Outcomes Common Terminology Criteria for Adverse Events PRO CTCAE
OUTLINE
INDUCTION Patients receive cladribine intravenously IV over 1-2 hours on days 1-5 cytarabine subcutaneously SC twice daily BID on days 1-10 and venetoclax orally PO once daily QD on days 1-21 of cycle 1
RE-INDUCTION Patients with 5 blasts after cycle 1 receive cladribine IV over 1-2 hours on days 1-5 cytarabine SC BID on days 1-10 and venetoclax PO QD on days 1-21 of cycle 2
REMISSION AFTER INDUCTION Patients who achieve complete remission CRCR with partial hematologic recoveryCR with incomplete blood count recoverymorphologic leukemia-free state MLFS after cycle 1 of induction receive cladribine IV over 1-2 hours on days 1-3 cytarabine SC BID on days 1-10 and venetoclax PO QD on days 1-21 of cycle 2
CONTINUING THERAPY Patients who achieve MLFS receive venetoclax PO QD on days 1-21 and azacitidine IV or SC QD on days 1-7 for 2 cycles then cladribine IV over 1-2 hours on days 1-3 cytarabine SQ BID on days 1-10 and venetoclax PO QD on days 1-21 for 2 cycles Cycles repeat every 28 days and continue to alternate every 2 cycles for up to cycle 18 in the absence of disease progression or unacceptable toxicity
Additionally patients undergo echocardiography ECHO or multigated acquisition scan MUGA and lumbar puncture LP during screening and as clinically indicated on study Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study
At completion of study treatment patients are followed up for 2 years
I Assess efficacy of the investigational treatment based on disease remission
SECONDARY OBJECTIVES
I Assess efficacy of the investigational treatment based on clinical response II Assess any-cause survival after treatment III Assess survival in the absence of treatment failure hematologic relapse or progressive disease
IV Assess duration of response based on morphological assessments V Assess the safety and tolerability of the regimen
EXPLORATORY OBJECTIVES
I Assess response based on measurable residual disease MRD II Identify markers of clonal or clinical response and resistance to treatment
III Assess participant quality of life QoL using Patient Reported Outcomes Common Terminology Criteria for Adverse Events PRO CTCAE
OUTLINE
INDUCTION Patients receive cladribine intravenously IV over 1-2 hours on days 1-5 cytarabine subcutaneously SC twice daily BID on days 1-10 and venetoclax orally PO once daily QD on days 1-21 of cycle 1
RE-INDUCTION Patients with 5 blasts after cycle 1 receive cladribine IV over 1-2 hours on days 1-5 cytarabine SC BID on days 1-10 and venetoclax PO QD on days 1-21 of cycle 2
REMISSION AFTER INDUCTION Patients who achieve complete remission CRCR with partial hematologic recoveryCR with incomplete blood count recoverymorphologic leukemia-free state MLFS after cycle 1 of induction receive cladribine IV over 1-2 hours on days 1-3 cytarabine SC BID on days 1-10 and venetoclax PO QD on days 1-21 of cycle 2
CONTINUING THERAPY Patients who achieve MLFS receive venetoclax PO QD on days 1-21 and azacitidine IV or SC QD on days 1-7 for 2 cycles then cladribine IV over 1-2 hours on days 1-3 cytarabine SQ BID on days 1-10 and venetoclax PO QD on days 1-21 for 2 cycles Cycles repeat every 28 days and continue to alternate every 2 cycles for up to cycle 18 in the absence of disease progression or unacceptable toxicity
Additionally patients undergo echocardiography ECHO or multigated acquisition scan MUGA and lumbar puncture LP during screening and as clinically indicated on study Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study
At completion of study treatment patients are followed up for 2 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