Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03586609|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Azacitidine Drug: Cladribine Drug: Cytarabine Drug: Venetoclax||Phase 2|
I. To assess the complete response (CR/complete response with incomplete recovery [CRi]) rate of patients with acute myeloid leukemia (AML) treated with venetoclax combined with cladribine (2-CDA) plus low-dose cytarabine (LDAC) alternating with 5-azacytidine (AZA).
I. To assess overall survival (OS) of patients with AML treated with venetoclax added to cladribine plus LDAC alternating with 5-azacytidine.
II. To assess the disease free survival (DFS) patients with AML treated with venetoclax added to cladribine plus LDAC alternating with 5-azacytidine and achieved a complete response (CR/CRi).
III. To assess the overall response rate of patients with AML treated with venetoclax added to cladribine plus LDAC alternating with 5-azacytidine.
IV. To assess toxicity and induction mortality of patients with AML treated with venetoclax added to cladribine plus LDAC alternating with 5-azacytidine.
INDUCTION: Patients receive cladribine intravenously (IV) daily over 1-2 hours on days 1-5, cytarabine subcutaneously (SC) twice daily (BID) on days 1-10, and venetoclax orally (PO) daily on days 1-21. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR or CRi after course 1 may receive a second induction cycle. Patients who do not achieve CR or CRi after second induction cycle may proceed to cycle 3 of consolidation per investigator.
Patients who achieve CR or CRi after cycle 1 of induction receive cladribine IV over 1-2 hours daily on days 1-3, cytarabine SC BID on days 1-10, and venetoclax PO once daily (QD) on days 1-21 of cycle 2. All patients receive cladribine IV daily over 1-2 hours of cycles 5-6, 9-10, 13-14, and 17-18, cytarabine SC BID on days 1-3 of cycles 5-6, 9-10, 13-14, and 17-18, venetoclax PO QD on days 1-21 of cycle 3-18, and azacitidine SC daily or IV over 30-60 minutes on days 1-7 of cycles 3-4, 7-8, 1-12, and 15-18. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-12 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Venetoclax Added to Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed by Consolidation With Cladribine Plus LDAC Alternating With 5-Azacitidine With Venetoclax in Patients With Untreated AML|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||January 3, 2020|
|Estimated Study Completion Date :||January 3, 2021|
Experimental: Treatment (cladribine, cytarabine, venetoclax, azacitidine)
See Detailed Description.
Given SC or IV
- Rate of complete response (CR/complete response with incomplete recovery [CRi]) [ Time Frame: Up to 5 years ]The optimum two-stage design will be implemented. Will be estimated along with the 95% confidence intervals.
- Overall response rate [ Time Frame: Up to 5 years ]Will be estimated along with the 95% confidence intervals.
- Overall survival (OS) [ Time Frame: Time interval between treatment start and the date of death or last follow-up, whichever occurred first, assessed up to 5 years ]Kaplan-Meier method will be used to assess the OS probabilities. The median OS will be reported, along with the 95% confidence intervals.
- Disease-free survival (DFS) [ Time Frame: Time interval between treatment start and the date of death or last follow-up, whichever occurred first, assessed up to 5 years ]Kaplan-Meier method will be used to assess the DFS probabilities. The median DFS will be reported, along with the 95% confidence intervals.
- Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]The Bayesian approach will be implemented for toxicity monitoring, where toxicity is defined as any grade 3 or higher non-hematological toxicity which is at least possibly related to the treatment that occurs during the first 2 cycles of treatment. Safety data will be summarized by category, severity and frequency.
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): NCT03586609
|Contact: Tapan Kadiaemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Tapan M. Kadia 713-563-3534|
|Principal Investigator: Tapan M. Kadia|
|Principal Investigator:||Tapan M Kadia||M.D. Anderson Cancer Center|