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

Status:	Recruiting
Conditions:	Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2019
Start Date:	November 15, 2017
End Date:	November 3, 2022
Contact:	Reference Study ID Number: GO39902 www.roche.com/about_roche/roche_worldwide.htm
Email:	global-roche-genentech-trials@gene.com
Phone:	888-662-6728 (U.S. and Canada)

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of DCLL9718S in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or DCLL9718S in Combination With Azacitidine in Patients With Previously Untreated AML Unsuitable for Intensive Induction Chemotherapy

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.

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

We found this trial at

sites

Yale School of Medicine

New Haven, Connecticut 06520

from

New Haven, CT