Open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of Azacitidine combined with Venetoclax in patients with higher-risk chronic myelomonocytic leukemia
AVENHIR trial is an open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of the combination of Azacitidine and Venetoclax in, hypomethylating agent-naïve, higher-risk chronic myelomonocytic leukemia patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Combination of Azacitidine and Venetoclax
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
Safety run-in
Determination of dose-limiting toxicities within the first two cycles of treatment
Time frame: after 2 cycles of treatment of the safety run-in phase patients (each cycle is 28 days)
Overall response rate
Overall response encompasses complete remission, partial remission, marrow response and clinical benefit according to protocol-defined criteria modified from MDS/MPN IWG criteria after 3 and 6 cycles of treatment
Time frame: after 3 and 6 cycles of treatment of the phase II patients (each cycle is 28 days)
Complete remission rate
Complete remission according to protocol-defined criteria modified from MDS/MPN IWG criteria after 3 and 6 cycles of treatment
Time frame: after 3 and 6 cycles of treatment (each cycle is 28 days)
Overall response rate at best response
Overall response (complete remission, partial remission, marrow response, clinical benefit) according to protocol-defined criteria modified from MDS/MPN IWG criteria at best response
Time frame: through study completion, an average of 5 years
Overall response rate after 3 and 6 cycles of treatment
Overall response (complete remission, partial remission, marrow response, clinical benefit) according to the DACOTA trial response criteria after 3 and 6 cycles of treatment
Time frame: after 3 and 6 cycles of treatment (each cycle is 28 days)
Duration of response
Duration of response defined as the time interval between the first date of achievement of any response according to MDS/MPN IWG criteria to progressive disease
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Hôpital Avicenne
Bobigny, France
Hôpital privé Sévigné
Cesson-Sévigné, France
CHU de Grenoble
Grenoble, France
Hôpital Claude Huriez
Lille, France
CHRU de Limoges
Limoges, France
Centre Hospitalier de Mont de Marsan
Mont-de-Marsan, France
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, France
CHU Hôtel Dieu
Nantes, France
...and 14 more locations
Time frame: through study completion, an average of 5 years
Identification and grading of adverse events
Safety profile, both hematological and non-hematological of treatment (Venetoclax combined with Azacitidine) including identification and grading of adverse events based on NCI CTCAE version 5.0
Time frame: through study completion, an average of 5 years
Overall survival
Overall survival defined as the time from inclusion until death or end of follow-up
Time frame: through study completion, an average of 5 years
Acute Myeloid Leukemia (AML)-free survival
AML-free survival defined as the time from inclusion to transformation to AML according to WHO 2016 criteria, death or end of follow-up, whichever occurs first
Time frame: through study completion, an average of 5 years
Progression-free survival
Progression-free survival defined as the time from inclusion to progressive disease according to MDS/MPN IWG criteria, transformation to AML, death or end of follow-up, whichever occurs first
Time frame: through study completion, an average of 5 years
Event-free survival
Event-free survival defined as the time from inclusion to failure to achieve any response according to MDS/MPN IWG criteria at the 6-cycle evaluation, occurence of progressive disease according to MDS/MPN IWG criteria, transformaion to AML, or death, whichever occurs first
Time frame: through study completion, an average of 5 years
Cumulative incidence of AML and cumulative risk of death without AML
Cumulative incidence of AML and cumulative risk of death without AML, considering death and transformation to AML as competing risk
Time frame: through study completion, an average of 5 years
Cumulative incidence of progressive disease or transformation to AML and cumulative risk of death without progression or AML
Cumulative incidence of progressive disease or transformation to AML and cumulative risk of death without progression or AML
Time frame: through study completion, an average of 5 years
Rate of Hematopoietic Stem Cell Transplantation (HSCT)
Rate of Hematopoietic Stem Cell Transplantation (HSCT) and post-HSCT ovrall survival and AML-free survival
Time frame: through study completion, an average of 5 years
Survival censoring at Hematopoietic Stem Cell Transplantation (HSCT)
Overall survival, AML-free survival and progressive-free survival censoring at Hematopoietic Stem Cell Transplantation (HSCT)
Time frame: through study completion, an average of 5 years
Subsequent therapy
Rate and description of subsequent therapy
Time frame: through study completion, an average of 5 years
Survival censoring to subsequent therapy
Overall survival, AML-free survival and progressive-free survival censoring at subsequent therapy
Time frame: through study completion, an average of 5 years