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

Completed · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT03298516

Run by

Genentech, Inc.

People needed

19

Starts

2017-11-15

Expected to finish

2019-07-16

Last updated by the study team

2019-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749 — New York, New York, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Princess Margaret Hospital; Department of Med Oncology — Toronto, Ontario, Canada
• Jewish General Hospital / McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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