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Acute Myeloid LeukemiaPhase 3CASCADENCT02785900

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 3 study testing 33A, azacitidine and decitabine in people with Acute Myeloid Leukemia, run by Seagen Inc. at 128 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
33A, azacitidine and decitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
128 sitesin 16 countries
Study dates
May 2016to 3 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
  • Intermediate or adverse cytogenetic risk
  • Eligible for therapy with either decitabine or azacitidine
  • Acceptable hematologic and organ function

Who cannot join

  • AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)
  • Patients who are candidates for allogeneic stem cell transplant at the time of enrollment
  • Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
  • Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)

Trial locations and contacts

128 sites in 16 countries.

128 sites in 16 countries

United States40 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of South Carolina/Hollings Cancer Center

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Florida Cancer Specialists - South Region

    Fort Myers, Florida, 33901

  • Shands Cancer Center / University of Florida

    Gainesville, Florida, 32610

  • Saint Francis Hospital / Bon Secours

    Greenville, South Carolina, 29601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • OnCare Hawaii

    Honolulu, Hawaii, 96813

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4095

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Memorial Cancer Institute

    Miami, Florida, 33028

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 30384

  • Florida Center for Cellular Therapy / Blood and Marrow Transplant Center

    Orlando, Florida, 32804

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • James P. Wilmot Cancer Center / University of Rochester Medical Center

    Rochester, New York, 14642

  • Intermountain Blood and Marrow Transplant/Acute Leukemia Program

    Salt Lake City, Utah, 84143

  • Brooke Army Medical Center

    San Antonio, Texas, 78234-7679

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • LSU Health Sciences Center / Feist Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Florida Cancer Specialists - North Region

    St. Petersburg, Florida, 33705

  • University of Kansas Cancer Center

    Westwood, Kansas, United States

Other trials in United States

France15 sites

  • CHU Amiens Picardie - Site Sud

    Amiens, 80054

  • Center Hospitalier Universitaire d' Angers

    Angers, 49933

  • Centre Hospitalier Victor Dupouy d'Argenteuil

    Argenteuil, 95107

  • Centre Hospitalier Universitaire Hopital Avicenne

    Bobigny, 93009

  • Hopital d'Instruction des Armees - Percy

    Clamart, 92141

  • CHRU de Lille

    Lille, 59037

  • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

    Limoges, 87042

  • Hopital Emile Muller

    Mulhouse, 68070

  • Centre Hospitalier Universitaire Nantes-Hotel Dieu

    Nantes, 44093

  • CHU de Nice - Hopital l'Archet

    Nice, 06200

  • Hopital Saint-Louis / Service d'Hematologie

    Paris, 75475

  • CHU Bordeaux Hopital Haut-Levaque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

    Rennes, 35033

Other trials in France

South Korea10 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Yeungnam University Medical Center

    Daegu, 705-703

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Chonnam National University Hwasun Hospital

    Hwasun, 519-763

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Seoul National University Hospital

    Jongno-gu, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Seoul Saint Mary's Hospital

    Seoul, 137-701

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

Spain9 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital de la Santa Creu i Sant Paul

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital San Pedro de Alcantara

    Cáceres, 10002

  • Hospital Universitario de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitaro de Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Israel8 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka Medical Center, Dept. of Oncology

    Beersheba, 84101

  • Carmel Medical Center

    Haifa, 34362

  • Edith Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49414

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Belgium7 sites

  • Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

    Antwerp, 2060

  • Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Centre Hospitalier Universitaire Sart Tilman Liege

    Liège, 4000

  • AZ Delta - Campus Wilgenstraat

    Roeselare, 8800

  • Cliniques Universitaires UCL de Mont-Goddine

    Yvoir, 5530

Other trials in Belgium

United Kingdom6 sites

  • County Durham and Darlington NHS Foundation Trust

    Darlington, DL3 6HX

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

  • North West London Hospitals NHS Trust

    Middlesex, HA1 3UJ

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Monash Medical Centre

    Clayton, 3168

  • St George Hospital

    Kogarah, 2217

  • Royal Perth Hospital

    Perth, 6000

  • Sunshine Hospital

    St Albans, 3021

Other trials in Australia

Germany5 sites

  • Stadtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Universitatsklinikum Koln

    Cologne, 50937

  • Marien Hospital Dusseldorf GmbH

    Düsseldorf, 40479

  • Universitatsklinik Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

Other trials in Germany

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

    Debrecen, 4004

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

    Kecskemét, 6000

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

    Szeged, 6720

Other trials in Hungary

Italy5 sites

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

    Orbassano, 10043

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61100

  • Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

    Roma, 00161

Other trials in Italy

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Ustav hematologie a krevni transfuze

    Prague, 128 20

Other trials in Czechia

Taiwan4 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • National Cheng-Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Austria2 sites

  • LKH Salzburg, Universitatsklinikum der PMU

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Poland2 sites

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, 02-097

Other trials in Poland

Luxembourg1 site

  • Centre Hospitalier Luxembourg - CHL Centre

    Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

Read the detailed description

Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo.

Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.

Being tested
33A, placebo, azacitidine, decitabine
Keywords
Antibodies, monoclonal, Antibody drug conjugate, Antigens, cluster of differentiation 33 (CD33), Drug therapy, Immunotherapy
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.

  • 33ADrug

    Also called vadastuximab talirine, SGN-CD33A

    33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push

  • placeboDrug

    Volume equivalent to 10 mcg/kg, every 4 weeks via IV push

  • azacitidineDrug

    75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks

  • decitabineDrug

    20 mg/m2 given IV x 5 days, every 4 weeks

Study groups in NCT02785900
Study groupRoleWhat they receive
33A + HMAExperimental33A plus azacitidine or decitabine
Receives: Drug: 33A; Drug: azacitidine; Drug: decitabine
placebo + HMAActive comparatorplacebo plus azacitidine or decitabine
Receives: Drug: placebo; Drug: azacitidine; Drug: decitabine

What is being measured

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

  1. Overall Survival

    Time from randomization to death due to any cause

    Measured: Up to 1.5 years

  2. Composite Complete Remission (CRc) Rate

    Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

    Measured: Up to 1.5 years

Secondary outcomes (8)

  1. Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate

    Number of patients who achieve both remission (CR or CRi) and MRD-negative status

    Measured: Up to 1.5 years

  2. Duration of Remission

    Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

    Measured: Up to approximately 9.5 months

  3. Event-free Survival

    Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.

    Measured: Up to approximately 11.24 months

  4. Leukemia-free Survival

    Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

    Measured: Up to approximately 9.49 months

  5. Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events

    Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. "Study treatment" in this data set refers to blinded study treatment.

    Measured: Up to 1.5 years

  6. Incidence of Grade 3 or Higher Laboratory Abnormalities

    Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)

    Measured: Up to 1.5 years

  7. Time to Complete Remission

    Time to CR or CRi is the time from randomization to the first documentation of CR/CRi

    Measured: Up to 1.5 years

  8. Mortality Rates at Day 30 and Day 60

    30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.

    Measured: Up to 60 days

Timeline

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

  1. First posted30 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion3 Oct 2017
  4. Study completion3 Oct 2017

Why it stopped: Due to safety; specifically a higher rate of deaths, including fatal infections, in the SGN33A arm versus the control arm

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02785900
Sponsor's protocol ID
SGN33A-005
Other IDs
2015-003482-28, 2015
Acronym
CASCADE
Status last verified
Nov 2018
First submitted
25 May 2016
Last updated
12 Dec 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 33A, azacitidine and decitabine in people with Acute Myeloid Leukemia, run by Seagen Inc. at 128 sites in 16 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, France, South Korea, Spain, Israel and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Up to 1.5 years). The study lists 2 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 NCT02785900.

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 12 Dec 2018.

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