Acute Myeloid Leukemia Clinical Trial
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
Summary
This Phase Ia/Ib, open-label, multicenter study will evaluate the safety, tolerability, and preliminary efficacy of DCLL9718S as a single agent (Phase Ia, Arm A) in participants with relapsed or refractory AML or in combination with azacitidine (Phase Ib, Arm B) in participants with previously untreated AML who are not eligible for intensive induction chemotherapy. Each arm will consist of two stages: a dose-escalation stage and an expansion stage. The dose-escalation stage is designed to establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for DCLL9718S alone (Arm A) or in combination with azacitidine (Arm B). The dose-expansion stage is designed to characterize the long-term safety and tolerability of DCLL9718S.
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
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There are 8 Locations for this study
Duarte California, 91010, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
New York New York, 10032, United States
Houston Texas, 77030, United States
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
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