A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT04102020
Phase
PHASE3
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Tablet: Oral
  • Azacitidine — DRUG
    Subcutaneous (SC) or intravenous (IV) injection
  • Azacitidine — DRUG
    Oral Tablet

Study Details

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Key Dates

Start date
Mar 26, 2020
Status verified
Aug 2025
Primary completion
Sep 29, 2022
Completion
Feb 20, 2026

Study Design

Enrollment
112 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Confirmation
    Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
  • Experimental: Part 3 (Dose Finding): Dose Escalation
    Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
  • Experimental: Part 3 (Dose Finding): Safety Expansion
    Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) [ Time Frame: Up to 28 days (Cycle 1) ]

Locations (27)

FacilityCityStateZIPSite coordinators
Mitchell Cancer Institute /ID# 216443MobileAlabama36604-
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156Fountain ValleyCalifornia92708-7501-
University of California, Los Angeles /ID# 219149Los AngelesCalifornia90095-
Colorado Blood Cancer Institute /ID# 214280DenverColorado80218-
St. Alphonsus Regional Medical /ID# 216424BoiseIdaho83706-
Duplicate_Rush University Medical Center /ID# 218815ChicagoIllinois60612-
University of Kentucky Markey Cancer Center /ID# 215048LexingtonKentucky40536-7001-
Duplicate_Norton Cancer Institute /ID# 216401LouisvilleKentucky40202-3700-
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583New OrleansLouisiana70121-
Tulane Medical Center - New Orleans /ID# 218166New OrleansLouisiana70112-2600-
Massachusetts General Hospital /ID# 217307BostonMassachusetts02114-
Tufts Medical Center /ID# 216110BostonMassachusetts02111-1552-
Duplicate_UMass Chan Medical School /ID# 218163WorcesterMassachusetts01655-
Oncology Hematology Associates (OHA) - Springfield /ID# 216351SpringfieldMissouri65807-5287-
Saint Louis University Cancer Center /ID# 218164St LouisMissouri63110-2539-
The John Theurer Cancer /ID# 215191HackensackNew Jersey07601-
Rutgers Cancer Institute of New Jersey /ID# 239708New BrunswickNew Jersey08901-
Weill Cornell Medical College /ID# 214847New YorkNew York10065-
Providence Portland Medical Ct /ID# 216231PortlandOregon97213-2933-
Fox Chase Cancer Center /ID# 239372PhiladelphiaPennsylvania19111-
UPMC Hillman Cancer Ctr /ID# 214051PittsburghPennsylvania15232-
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066GreenvilleSouth Carolina29605-4255-
St Francis Cancer Center /ID# 216115GreenvilleSouth Carolina29607-5253-
Gibbs Cancer Center & Research /ID# 216192SpartanburgSouth Carolina29303-3040-
Tennessee Oncology-Nashville Centennial /ID# 218757NashvilleTennessee37203-1632-
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584DallasTexas75246-2003-
University of Texas MD Anderson Cancer Center /ID# 225201HoustonTexas77030-

Find similar trials in Mobile, AL

By research site
Mitchell Cancer Institute· Mobile, ALCompassionate Cancer Care Research Group - Fountain Valley· Fountain Valley, CAUniversity of California, Los Angeles· Los Angeles, CAColorado Blood Cancer Institute· Denver, COSt. Alphonsus Regional Medical· Boise, IDDuplicate_Rush University Medical Center· Chicago, IL

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