Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05600894
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2022-10-27
Brief Title:
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic SyndromeMyeloproliferative Neoplasm
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Venetoclax In Combination With ASTX727 an All-ORal TherapY for Chronic Myelomonocytic Leukemia and Other MDSMPN With Excess Blasts VICTORY-MDSMPN a Randomized Phase 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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 tests whether decitabine and cedazuridine ASTX727 in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia CMML myelodysplastic syndromemyeloproliferative neoplasm MDSMPN with excess blasts Blasts are immature blood cells Decitabine is in a class of medications called hypomethylation agents It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow Cobimetinib is used in patients whose cancer has a mutated changed form of a gene called BRAF It is in a class of medications called kinase inhibitors It works by blocking the action of an abnormal protein that signals cancer cells to multiply This helps slow or stop the spread of cancer cells 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 The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML or MDSMPN with excess blasts
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the complete remission rates of ASTX727 and ASTX727 plus venetoclax in subjects with chronic myelomonocytic leukemia CMML and non-CMML myelodysplastic syndrome MDSmyeloproliferative neoplasm MPN with excess 5 blasts
SECONDARY OBJECTIVES
I To evaluate the overall response rate complete response CR partial response PR marrow response with erythroid response of ASTX727 versus ASTX727 venetoclax in this patient population
II To determine the overall survival progression-free survival allogeneic hematopoietic stem cell transplantation rate clearance of the malignant clone clonality at time of hematologic remission number of red cell and platelet transfusions required and toxicity of ASTX727 versus ASTX727 venetoclax
OUTLINE Patients are randomized to 1 of 2 arms
ARM I COMBINATION THERAPY Patients receive ASTX727 orally PO daily QD for 5 consecutive days starting on day 3 of treatment cycle 1 followed by day 1 of each subsequent cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive venetoclax PO QD on days 1 through 14 of each treatment cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow biopsies and collection of blood and buccal samples throughout the study
ARM II MONO THERAPY Patients receive ASTX727 PO QD for 5 consecutive days starting on day 3 of treatment cycle 1 followed by day 1 of each subsequent cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who do not have response to treatment may cross over to Arm I Patients also undergo bone marrow biopsies and collection of blood and buccal samples throughout the study
After completion of study treatment patients are followed up every 6 months for 5 years or until death whichever occurs first
I To evaluate the complete remission rates of ASTX727 and ASTX727 plus venetoclax in subjects with chronic myelomonocytic leukemia CMML and non-CMML myelodysplastic syndrome MDSmyeloproliferative neoplasm MPN with excess 5 blasts
SECONDARY OBJECTIVES
I To evaluate the overall response rate complete response CR partial response PR marrow response with erythroid response of ASTX727 versus ASTX727 venetoclax in this patient population
II To determine the overall survival progression-free survival allogeneic hematopoietic stem cell transplantation rate clearance of the malignant clone clonality at time of hematologic remission number of red cell and platelet transfusions required and toxicity of ASTX727 versus ASTX727 venetoclax
OUTLINE Patients are randomized to 1 of 2 arms
ARM I COMBINATION THERAPY Patients receive ASTX727 orally PO daily QD for 5 consecutive days starting on day 3 of treatment cycle 1 followed by day 1 of each subsequent cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also receive venetoclax PO QD on days 1 through 14 of each treatment cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow biopsies and collection of blood and buccal samples throughout the study
ARM II MONO THERAPY Patients receive ASTX727 PO QD for 5 consecutive days starting on day 3 of treatment cycle 1 followed by day 1 of each subsequent cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients who do not have response to treatment may cross over to Arm I Patients also undergo bone marrow biopsies and collection of blood and buccal samples throughout the study
After completion of study treatment patients are followed up every 6 months for 5 years or until death whichever occurs first
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |
| NCI-2022-08797 | REGISTRY | None | None |
| 10538 | OTHER | None | None |
| 10538 | OTHER | None | None |