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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT03298516

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Yale School of Medicine
New Haven Connecticut, 06510, United States
Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749
New York New York, 10032, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Alberta Hospital
Edmonton Alberta, T6G 1, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto Ontario, M5G 2, Canada
Jewish General Hospital / McGill University
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT03298516

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider