Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550442
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2020-09-09
Brief Title:
Venetoclax and Azacitidine for the Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study of Venetoclax in Combination With Azacitidine in RelapsedRefractory High-Risk Myelodysplastic Syndrome MDS or Chronic Myelomonocytic Leukemia CMML
Status:
RECRUITING
Status Verified Date:
2024-04
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 investigates the side effects and best dose of venetoclax when given together with azacitidine and to see how well it works in treating patients with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back relapsed or has not responded to treatment refractory Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Chemotherapy drugs such as 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 and azacitidine together may help to control myelodysplastic syndrome or chronic myelomonocytic leukemia
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and tolerability phase 1 and overall response rate ORR phase 2 of venetoclax in combination with azacitidine in patients with high risk myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML with bone marrow excess blasts 5 that are relapsedrefractory to prior hypomethylating agent HMA therapy
SECONDARY OBJECTIVES
I Rate of complete remission CR II Rate of marrowmorphologic complete remission mCR III Rate of hematologic improvement HI erythroidplateletneutrophil responses
IV Rate of red blood cell RBC transfusion independence V Rate of platelet PLT transfusion independence VI Rate of cytogenetic response VII Rate of bone marrow blast response VIII Time to transformation to acute myeloid leukemia AML IX Duration of response DOR X Overall survival OS XI Progression-free survival PFS XII Time to next MDS treatment TTNT XIII Event-free survival EFS
EXPLORATORY OBJECTIVE
I To investigate the effects of therapy on MDS and to identify biological markers of response to venetoclax andor its combination with azacitidine
OUTLINE This is a phase I dose-escalation study of venetoclax followed by a phase II study
Patients receive venetoclax orally PO daily on days 1-14 and azacitidine intravenously IV over 15 minutes or subcutaneously SC on days 1-5 Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days and then every 3-6 months for up to 5 years
I To determine the safety and tolerability phase 1 and overall response rate ORR phase 2 of venetoclax in combination with azacitidine in patients with high risk myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML with bone marrow excess blasts 5 that are relapsedrefractory to prior hypomethylating agent HMA therapy
SECONDARY OBJECTIVES
I Rate of complete remission CR II Rate of marrowmorphologic complete remission mCR III Rate of hematologic improvement HI erythroidplateletneutrophil responses
IV Rate of red blood cell RBC transfusion independence V Rate of platelet PLT transfusion independence VI Rate of cytogenetic response VII Rate of bone marrow blast response VIII Time to transformation to acute myeloid leukemia AML IX Duration of response DOR X Overall survival OS XI Progression-free survival PFS XII Time to next MDS treatment TTNT XIII Event-free survival EFS
EXPLORATORY OBJECTIVE
I To investigate the effects of therapy on MDS and to identify biological markers of response to venetoclax andor its combination with azacitidine
OUTLINE This is a phase I dose-escalation study of venetoclax followed by a phase II study
Patients receive venetoclax orally PO daily on days 1-14 and azacitidine intravenously IV over 15 minutes or subcutaneously SC on days 1-5 Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up within 30 days and then every 3-6 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-2020-06538 | REGISTRY | None | None |
| 2020-0128 | OTHER | M D Anderson Cancer Center | None |