Clinical trial NCT03941964: A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Official title: A Phase 3b, Single-Arm, Multicenter Open-Label Study of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in AML Patients Ineligible for Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Cancer
Keywords: Acute Myeloid Leukemia (AML)
Cancer
Treatment-naïve
Venetoclax
Azacitidine
Decitabine
Outpatient setting
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Participant has confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria
* Participant is deemed by the investigator to be an appropriate candidate for outpatient ramp-up of venetoclax
* Participant is not eligible to receive treatment with standard cytarabine and anthracycline induction regimens
* Participant has not received prior treatment for AML (treatment naïve) with the exception of hydroxyurea
* Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening
* Participant can have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors or other agents with the exception of hypomethylating agents
* Participant has adequate kidney, liver, and hematology laboratory values as detailed in the protocol
* Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3

Exclusion Criteria:

Has a history of the following conditions:

* Acute promyelocytic leukemia
* Known active central nervous system involvement with AML
* Positive for HIV (HIV testing is not required)
* Positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months
* Cardiovascular disability status of New York Heart Association Class \> 2
* Chronic respiratory disease that requires continuous oxygen or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
* Malabsorption syndrome or other condition that precludes enteral route of administration

Has a history of other malignancies within 2 years prior to study entry, with the exception of:

* Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast
* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent

Primary outcomes:
measure: Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
timeFrame: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
Secondary outcomes:
measure: Percentage of Participants With Complete Remission (CR)
timeFrame: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
measure: Percentage of Participants With Complete Remission With Incomplete Blood Count Recovery (CRi)
timeFrame: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
measure: Percentage of Participants With Post-baseline Transfusion Independence
timeFrame: From the first dose of study drug to the last dose of study drug +30 days, or death, or initiation of post-treatment therapy, whichever occurred earliest. Median time on follow-up was 183.5 days and 195.0 days, respectively.
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona Oncology Associates, PC-HOPE /ID# 211509
state: Arizona
city: Denver
country: United States
facility: Colorado Blood Cancer Institute /ID# 212800
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers /ID# 211508
state: Colorado
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology /ID# 223523
state: Indiana
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA /ID# 212837
state: Minnesota
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. /ID# 212779
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center /ID# 211504
state: Oregon
city: Charleston
country: United States
facility: Charleston Oncology, P.A. /ID# 211471
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Inst - Eastside /ID# 211466
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology - Chattanooga / McCallie /ID# 212717
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 210944
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown /ID# 212780
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 211503
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute /ID# 213311
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center /ID# 211510
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Northeast Texas /ID# 213908
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: