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Completed

NCT Number: NCT03298516

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

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.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCLL9718S

Drug

DCLL9718S will be administered as per the schedule specified in the respective arm.

Azacitidine

Drug

Azacitidine will be administered as per the schedule specified in the respective arm.

Other names: Vidaza

Primary outcomes

  1. Percentage of participants With Adverse Events (AEs)

    Time frame: Baseline up to end of study (up to approximately 3 years)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Serum Concentration of DCLL9718S

    Time frame: up to 3 years

  2. Plasma Concentration of Azacitidine

    Time frame: up to 3 years

  3. Area Under the Concentration-Time Curve (AUC) of DCLL9718S

    Time frame: up to 3 years

  4. Maximum Plasma Concentration Observed (Cmax) of DCLL9718S

    Time frame: up to 3 years

  5. Total Clearance of DCLL9718S

    Time frame: up to 3 years

  6. Terminal Half-Life (t1/2) of DCLL9718S

    Time frame: up to 3 years

  7. Volume of Distribution Under Steady-State (Vss) of DCLL9718S

    Time frame: up to 3 years

  8. 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)

  9. 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)

  10. Overall Survival

    Time frame: From the date of first treatment to the date of death from any cause (up to approximately 3 years)

  11. 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)

  12. 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)

  13. Change From Baseline in Anti-Drug Antibody (ADA) to DCLL9718S

    Time frame: Baseline up to end of study (up to approximately 3 years)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2017
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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