A Study of DCLL9718S in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Participants With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy
Leukemia, Myeloid, Acute
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of AML per World Health Organization (WHO) criteria (except acute promyelocytic leukemia)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Adequate end-organ function
- Willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment
Specifically for participants in Arm A:
- Age greater than or equal to (>/=) 18 years
- Relapsed or refractory acute myeloid leukemia
- Participants cannot have received more than two prior regimens
Specifically for participants in Arm B:
- Treatment-naive participants with AML who are >/=75 years old
- Treatment-naive participants unfit for induction chemotherapy for AML due to comorbidities who are >/=65 years old
Exclusion Criteria:
- Diagnosis of acute promyelocytc leukemia
- Prior allogeneic stem cell transplant or solid organ transplant
- Active central nervous system (CNS) involvement by leukemia
- History of idiopathic pulmonary fibrosis, organizing pneumonitis (for example [e.g.], bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis
- Treatment with investigational therapy within 14 days prior to Cycle 1, Day 1
- Treatment with a monoclonal antibody within 30 days prior to Cycle 1, Day 1
- Positive for hepatitis C virus (HCV) antibody at screening
- Active hepatitis B virus (HBV) infection
- Known positivity for human immunodeficiency virus (HIV)
- History of other malignancy within 2 years prior to screening
- Family history of long QT syndrome, with a QTc interval greater than (>) 480 millisecond (msec) at screening, or taking concurrent medications known to prolong QT/QTc interval
Sites / Locations
- City of Hope
- University of Colorado Hospital - Anschutz Cancer Pavilion
- Yale School of Medicine
- Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
- MD Anderson Cancer Center
- University of Alberta Hospital
- Princess Margaret Hospital; Department of Med Oncology
- Jewish General Hospital / McGill University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A: DCLL9718S
Arm B: DCLL9718S and Azacitidine
Participants will receive escalating doses of DCLL9718S intravenously (IV) in each 21-day cycle to determine MTD and RP2D in dose-escalation stage followed by DCLL9718S IV at RP2D in each 21-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.
Participants will receive escalating doses of DCLL9718S (starting dose: at least one dose level below a completed and tolerated DCLL9718S monotherapy in Arm A) IV in each 28-day cycle and azacitidine 75 milligrams per square meter (mg/m^2) subcutaneously (SC) or IV on Days 1-7 of each 28-day cycle to determine MTD and RP2D of DCLL9718S in dose-escalation stage followed by DCLL9718S IV at RP2D in each 28-day cycle and azacitidine 75 mg/m^2 SC or IV on Days 1-7 of each 28-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met. Azacitidine may also be given on Days 1-5 and Days 8-9 depending on institutional preference.