A Phase 1 interventional study of DCLL9718S and Azacitidine in Leukemia, Myeloid, Acute, sponsored by Genentech, Inc.. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
Specifically for participants in Arm A:
Specifically for participants in Arm B:
Exclusion Criteria:
Participants will receive escalating doses of DCLL9718S intravenously (IV) in each 21-day cycle to determine MTD and RP2D in dose-escalation stage followed by DCLL9718S IV at RP2D in each 21-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.
Drug: DCLL9718S
Participants will receive escalating doses of DCLL9718S (starting dose: at least one dose level below a completed and tolerated DCLL9718S monotherapy in Arm A) IV in each 28-day cycle and azacitidine 75 milligrams per square meter (mg/m\^2) subcutaneously (SC) or IV on Days 1-7 of each 28-day cycle to determine MTD and RP2D of DCLL9718S in dose-escalation stage followed by DCLL9718S IV at RP2D in each 28-day cycle and azacitidine 75 mg/m\^2 SC or IV on Days 1-7 of each 28-day cycle in dose-expansion stage until disease progression, unacceptable toxicity, or any other discontinuation criteria are met. Azacitidine may also be given on Days 1-5 and Days 8-9 depending on institutional preference.
Drug: DCLL9718S · Drug: Azacitidine
DCLL9718S will be administered as per the schedule specified in the respective arm.
Azacitidine will be administered as per the schedule specified in the respective arm.
Also known as: Vidaza
Percentage of participants With Adverse Events (AEs)
Time frame: Baseline up to end of study (up to approximately 3 years)
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 1 (Cycle length: 21 days for Arm A and 28 days for Arm B)
MTD of DCLL9718S
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 1 (Cycle length: 21 days for Arm A and 28 days for Arm B)
RP2D of DCLL9718S
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 1 (Cycle length: 21 days for Arm A and 28 days for Arm B)
Serum Concentration of DCLL9718S
Time frame: up to 3 years
Plasma Concentration of Azacitidine
Time frame: up to 3 years
Area Under the Concentration-Time Curve (AUC) of DCLL9718S
Time frame: up to 3 years
Maximum Plasma Concentration Observed (Cmax) of DCLL9718S
Time frame: up to 3 years
Total Clearance of DCLL9718S
Time frame: up to 3 years
Terminal Half-Life (t1/2) of DCLL9718S
Time frame: up to 3 years
Volume of Distribution Under Steady-State (Vss) of DCLL9718S
Time frame: up to 3 years
Percentage of Participants With Complete Remission (CR), CR With Incomplete Blood Count Recovery (CRi), CR With Incomplete Platelet Count Recovery (CRp), and Overall Response, Assessed as per International Working Group (IWG) Criteria
Time frame: From the date of first treatment to disease progression or relapse or death from any cause (up to approximately 3 years)
Duration of Response, Assessed as per IWG Criteria
Time frame: From the date of first response to the earliest recurrence or disease progression (up to approximately 3 years)
Overall Survival
Time frame: From the date of first treatment to the date of death from any cause (up to approximately 3 years)
Event-Free Survival (EFS), Assessed as per IWG Criteria
Time frame: From the date of first treatment until treatment failure, relapsed from CR, CRp, or CRi, or death from any cause, whichever occurs first (up to approximately 3 years)
Progression-Free Survival (PFS), Assessed as per IWG Criteria
Time frame: From the date of first treatment to disease progression or relapse or death from any cause (up to approximately 3 years)
Change From Baseline in Anti-Drug Antibody (ADA) to DCLL9718S
Time frame: Baseline up to end of study (up to approximately 3 years)
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.