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A study of the safety of a new medicine (DCLL9718S) in patients with a type of blood cancer (acute myeloid leukemia)
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
Cancer Leukemia
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT03298516, GO39902
Condition
Leukemia, Myeloid, Acute
Official Title
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
Study 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
All
≥ 18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com