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Acute Myeloid LeukemiaPhase 1NCT02326584

A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML

A Phase 1 study testing Standard dose cytarabine for induction, SGN-CD33A and Daunorubicin in people with Acute Myeloid Leukemia and Acute Myelogenous Leukemia, run by Seagen Inc. at 13 sites in United States.

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 study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Standard dose cytarabine for induction, SGN-CD33A and Daunorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
13 sitesUnited States
Study dates
Dec 2014to 10 Apr 2018
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

  • All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
  • Eastern Cooperative Oncology Group status of 0 or 1
  • Adequate baseline renal and hepatic function
  • Central venous access
  • Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance

Who cannot join

  • Previous treatment for MDS or MPN for dose escalation cohorts
  • Inadequate lung function
  • Inadequate heart function

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195

  • James Cancer Hospital / Ohio State University

    Columbus, Ohio, 43210

  • Charles A. Sammons Cancer Center / Baylor University Medical Center

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Karmanos Cancer Institute / Wayne State University

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • Cardinal Bernardin Cancer Center / Loyola University Medical Center

    Maywood, Illinois, 60153

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 30384

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.

Read the detailed description

The study will be conducted in the following distinct parts:

Part A: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 and Day 4 dosing)

Part B: Consolidation dose escalation - consolidation combined with SGN-CD33A; up to 4 cycles of consolidation therapy will be administered after SGN-CD33A (Day 1 of each cycle).

Part C: Maintenance - SGN-CD33A Monotherapy; Up to 24 patients with and up to 24 patient without prior allogeneic stem cell transplant will be treated with SGN-CD33A. Both arms will enroll simultaneously. SGN-CD33A will be administered on Day 1 of each 6-week cycle for up to 8 cycles.

Part D: Induction plus consolidation - induction/consolidation combined with SGN-CD33A; patients who achieve a CR/CRi (with or without a second induction) will receive up to 4 cycles of consolidation therapy administered after SGN-CD33A (Day 1 of each cycle).

Part E: Induction dose escalation - 7+3 combined with SGN-CD33A (Day 1 dosing)

Being tested
Standard dose cytarabine for induction, SGN-CD33A, Daunorubicin, High dose cytarabine for consolidation
Keywords
Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD33 Antigen, Drug Therapy, Acute Myelogenous Leukemia
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.

  • Standard dose cytarabine for inductionDrug

    100 mg/m2/day Days 1-7

  • SGN-CD33ADrug

    Also called vadastuximab talirine

    Given intravenously Day 1 or Days 1 and 4 of each cycle

  • DaunorubicinDrug

    60 mg/m2/day Days 1-3

  • High dose cytarabine for consolidationDrug

    3g/m2 on Days 1, 3, and 5 of each cycle

Study groups in NCT02326584
Study groupRoleWhat they receive
Induction with SGN-CD33AExperimental7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Receives: Drug: Standard dose cytarabine for induction; Drug: SGN-CD33A; Drug: Daunorubicin
Consolidation with SGN-CD33AExperimentalHigh dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
Receives: Drug: SGN-CD33A; Drug: High dose cytarabine for consolidation
SGN-CD33A MaintenanceExperimentalSGN-CD33A Monotherapy (42-day cycles)
Receives: Drug: SGN-CD33A
Induction and Consolidation with SGN-CD33AExperimental7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A
Receives: Drug: Standard dose cytarabine for induction; Drug: SGN-CD33A; Drug: Daunorubicin; Drug: High dose cytarabine for consolidation

What is being measured

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

  1. Incidence of adverse events

    Measured: Through 1 month following last dose

  2. Incidence of laboratory abnormalities

    Measured: Through 1 month following last dose

  3. Incidence of dose-limiting toxicity (DLT)

    Measured: Through 1 month following last dose

Secondary outcomes (6)

  1. Complete remission (CR) rate at the end of induction

    Measured: Through 1 month following last dose

  2. Leukemia-free survival

    Measured: Up to approximately 3 years

  3. Overall survival

    Measured: Up to approximately 3 years

  4. Blood concentrations of SGN-CD33A and metabolites

    Measured: Up to approximately 3 years

  5. Incidence of antitherapeutic antibodies (ATA)

    Measured: Up to approximately 3 years

  6. Rate of minimal residual disease (MRD) clearance

    Measured: 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 posted29 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion30 Jan 2017
  4. Study completion10 Apr 2018

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
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326584
Sponsor's protocol ID
SGN33A-002
Status last verified
May 2018
First submitted
18 Dec 2014
Last updated
9 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Standard dose cytarabine for induction, SGN-CD33A and Daunorubicin in people with Acute Myeloid Leukemia and Acute Myelogenous Leukemia, run by Seagen Inc. at 13 sites in United States.

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 5 inclusion and 3 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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?

Incidence of adverse events (time frame: Through 1 month following last dose). The study lists 3 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 NCT02326584.

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 9 May 2018.

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