Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04746235|
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia||Drug: Decitabine and Cedazuridine Drug: Venetoclax||Phase 2|
I. To determine the overall response rate (ORR) of decitabine and cedazuridine (ASTX727) in combination with venetoclax in patients with refractory/relapsed acute myeloid leukemia (AML).
II. To determine the overall response rate (ORR) of ASTX727 in combination with venetoclax in elderly (> 60 year old) patients with newly diagnosed acute myeloid leukemia (AML) not eligible for intensive chemotherapy.
I. To determine the duration of response, disease-free survival (DFS), and overall survival (OS) of patients with refractory/relapsed AML treated with this combination.
II. To determine similar outcomes for newly diagnosed patients with AML who are not candidates for intensive chemotherapy.
III. To determine the safety of venetoclax in combination with ASTX727 in patients with refractory/ relapsed AML, and newly diagnosed patients with AML not candidates for intensive chemotherapy.
IV. To determine the number of relapsed patients able to proceed to stem cell transplantation upon achieving response with the combination venetoclax/ASTX727 regimen.
I. To characterize the pharmacokinetic (PK) profiles of ASTX727 when combined with venetoclax.
Patients receive decitabine and cedazuridine orally (PO) daily on days 1-5 and venetoclax PO daily on days 1-28 of the first cycle and on days 1-21 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with an objective response are followed every 3-6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Venetoclax in Combination With ASTX727 in Patients With Relapsed/Refractory Acute Myeloid Leukemia, and Newly Diagnosed Elderly Patients With AML Who Are Not Candidates for Intensive Chemotherapy|
|Actual Study Start Date :||February 21, 2021|
|Estimated Primary Completion Date :||October 15, 2022|
|Estimated Study Completion Date :||October 15, 2022|
Experimental: Treatment (decitabine and cedazuridine, venetoclax)
Patients receive decitabine and cedazuridine PO daily on days 1-5 and venetoclax PO daily on days 1-28 of the first cycle and on days 1-21 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Decitabine and Cedazuridine
- Overall response rate (ORR) [ Time Frame: Within 3 months of treatment initiation ]Will be defined as the proportion of patients who had CR (complete remission), CRp (complete remission with incomplete platelet recovery), CRi (complete remission with incomplete count recovery), PR (partial response) or marrow clearance of blasts within 3 months of treatment initiation among adult patients with acute myeloid leukemia (AML). Response criteria will be modified from the International Working Group for AML. Will estimate the ORR for the combination treatments for each cohort, along with the 90% credible intervals. The association between ORR and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate.
- Overall incidence and severity of all adverse events [ Time Frame: Up to 5 years post treatment ]Will be assessed by Common Toxicity Criteria version 5.0.
- Disease free survival [ Time Frame: Up to 5 years post treatment ]Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
- Overall survival [ Time Frame: Up to 5 years post treatment ]Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746235
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Farhad Ravandi-Kashani 713-745-0394 email@example.com|
|Principal Investigator: Farhad Ravandi-Kashani|
|Principal Investigator:||Farhad Ravandi-Kashani||M.D. Anderson Cancer Center|