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Acute Lymphoid LeukemiaPhase 2NCT01461538

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

A Phase 2 study testing brentuximab vedotin in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia, run by Seagen Inc. at 29 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies. Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
brentuximab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
29 sitesUnited States
Study dates
Oct 2011to Dec 2014
Phase
Phase 2
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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Who cannot join

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106-5055

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Dallas Presbyterian

    Dallas, Texas, 75231

  • Texas Oncology Denton South

    Denton, Texas, 76210

  • City of Hope

    Duarte, California, 91010-3000

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • Willamette Valley Cancer and Research / USOR

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology - Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • St. Francis Hospital

    Greenville, South Carolina, 29605

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4003

  • MD Anderson Cancer Center Leukemia Group

    Houston, Texas, 77030

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

  • Minnesota Oncology Hematology P.A.

    Minneapolis, Minnesota, 55404

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Texas Oncology - Central Austin Cancer Center

    Round Rock, Texas, 78731

  • Cancer Centers of South Texas - HOAST

    San Antonio, Texas, 78229

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216

  • Northwest Cancer Specialists, P.C.

    Tulatin, Oregon, 97062

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Yakima Valley Memorial Hospital / North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

Being tested
brentuximab vedotin
Keywords
Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Solid Tumors, Anemia, Refractory, with Excess of Blasts, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethyl Auristatin E
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts, Myelodysplastic Syndromes, Hematologic Diseases

What participants receive

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

  • brentuximab vedotinDrug

    Also called Adcetris; SGN-35

    1.8 mg/kg every 3 weeks by intravenous (IV) infusion

  • brentuximab vedotinDrug

    Also called Adcetris; SGN-35

    2.4 mg/kg every 3 weeks by intravenous (IV) infusion

  • brentuximab vedotinDrug

    Also called Adcetris; SGN-35

    1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion

Study groups in NCT01461538
Study groupRoleWhat they receive
Brentuximab vedotin 1.8 mg/kgExperimentalBrentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Receives: Drug: brentuximab vedotin
Brentuximab vedotin 2.4 mg/kgExperimentalBrentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
Receives: Drug: brentuximab vedotin
Brentuximab vedotin 1.2 mg/kgExperimentalBrentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Receives: Drug: brentuximab vedotin

What is being measured

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

  1. Objective Response Rate (ORR) by Investigator

    Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

    Measured: Up to approximately 3 years

Secondary outcomes (11)

  1. Complete Remission (CR) Rate by Investigator

    Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

    Measured: Up to approximately 3 years

  2. Duration of Objective Response by Kaplan-Meier Analysis

    Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

    Measured: Up to approximately 2 years

  3. Duration of Complete Response by Kaplan-Meier Analysis

    Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

    Measured: Up to approximately 2 years

  4. Progression-Free Survival by Kaplan-Meier Analysis

    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause

    Measured: Up to approximately 2 years

  5. Adverse Events by Severity, Seriousness, and Relationship to Treatment

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

    Measured: Up to approximately 3 years

  6. Laboratory Abnormalities >/= Grade 3

    Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category

    Measured: Up to approximately 3 years

  7. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)

    Measured: Up to approximately 3 years

  8. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)

    Measured: Up to approximately 3 years

  9. Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Measured: Up to approximately 3 years

  10. Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)

    Measured: Up to approximately 3 years

  11. Incidence of Anti-therapeutic Antibodies (ATA)

    Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.

    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 posted28 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01461538
Sponsor's protocol ID
SGN35-013
Status last verified
Feb 2016
First submitted
24 Oct 2011
Last updated
4 Mar 2016
Data monitoring committee
No

Publications

  • Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8.

    PubMed 29222199

  • Borate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27.

    PubMed 26994848

  • Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.

    PubMed 23624209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia, run by Seagen Inc. at 29 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 4 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 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Mar 2016). 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?

Objective Response Rate (ORR) by Investigator (time frame: Up to approximately 3 years). 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 NCT01461538, which also lists 3 linked publications.

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 4 Mar 2016.

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