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Leukemia, Myeloid, AcutePhase 1NCT03298516

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

A Phase 1 study testing DCLL9718S and Azacitidine in people with Leukemia, Myeloid, Acute, run by Genentech, Inc. at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
DCLL9718S and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
8 sitesin 2 countries
Study dates
15 Nov 2017to 16 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States5 sites

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center; Research Pharmacy, Irving Pavillion, Ip 7-749

    New York, New York, 10032

Other trials in United States

Canada3 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1C9

  • Jewish General Hospital / McGill University

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital; Department of Med Oncology

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Being tested
DCLL9718S, Azacitidine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCLL9718SDrug

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

  • AzacitidineDrug

    Also called Vidaza

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

Study groups in NCT03298516
Study groupRoleWhat they receive
Arm A: DCLL9718SExperimentalParticipants 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.
Receives: Drug: DCLL9718S
Arm B: DCLL9718S and AzacitidineExperimentalParticipants 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.
Receives: Drug: DCLL9718S; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants With Adverse Events (AEs)

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

  2. Percentage of Participants With Dose-Limiting Toxicities (DLTs)

    Measured: 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

    Measured: 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

    Measured: 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 (13)

  1. Serum Concentration of DCLL9718S

    Measured: up to 3 years

  2. Plasma Concentration of Azacitidine

    Measured: up to 3 years

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

    Measured: up to 3 years

  4. Maximum Plasma Concentration Observed (Cmax) of DCLL9718S

    Measured: up to 3 years

  5. Total Clearance of DCLL9718S

    Measured: up to 3 years

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

    Measured: up to 3 years

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

    Measured: 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

    Measured: 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

    Measured: From the date of first response to the earliest recurrence or disease progression (up to approximately 3 years)

  10. Overall Survival

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start15 Nov 2017
  3. Primary completion16 Jul 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298516
Sponsor's protocol ID
GO39902
Status last verified
Nov 2019
First submitted
27 Sep 2017
Last updated
19 Nov 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Daver N, Salhotra A, Brandwein JM, Podoltsev NA, Pollyea DA, Jurcic JG, Assouline S, Yee K, Li M, Pourmohamad T, Samineni D, Sumiyoshi T, Vaze A, Dere RC, Ma C, Cooper J. A Phase I dose-escalation study of DCLL9718S, an antibody-drug conjugate targeting C-type lectin-like molecule-1 (CLL-1) in patients with acute myeloid leukemia. Am J Hematol. 2021 May 1;96(5):E175-E179. doi: 10.1002/ajh.26136. Epub 2021 Mar 11. No abstract available.

    PubMed 33617672

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCLL9718S and Azacitidine in people with Leukemia, Myeloid, Acute, run by Genentech, Inc. at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants With Adverse Events (AEs) (time frame: Baseline up to end of study (up to approximately 3 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298516, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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