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Hematopoietic/Lymphoid CancerPhase 1/2NCT01620229

Brentuximab Vedotin After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

A Phase 1/2 study testing brentuximab vedotin, laboratory biomarker analysis and pharmacological study in people with Hematopoietic/Lymphoid Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I/II trial studies the side effects and best way to give brentuximab vedotin and to see how well it works after donor stem cell transplant in treating patients with hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Hematopoietic/Lymphoid Cancer
What is being tested?
brentuximab vedotin, laboratory biomarker analysis and pharmacological study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2013to Apr 2014
Phase
Phase 1/2
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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have a cluster of differentiation (CD)30+ malignancy, with CD30 positivity demonstrated either at time of original diagnosis or at any subsequent time point
  • Patients must have undergone allogeneic HCT from a related or unrelated donor; acceptable donors include:
  • Related donors: genotypically or phenotypically identical by serological typing for human leukocyte antigen (HLA)-A, -B, -C, and at the allele level for -DRB1 and -DQB1
  • Unrelated donors: Fred Hutchinson Cancer Research Center (FHCRC) matching allowed will be grade 1.0 to 2.1: matched for HLA-A, -B, -C, -DRB1 and -DQB1 by high-resolution typing
  • For all donors, a single allele disparity will be allowed for HLA-A, -B, or -C as defined by high-resolution typing
  • Patients with HLA-haploidentical donors are not eligible
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  • Patients must have documented post-transplant donor CD3+ chimerism of > 50% in sorted peripheral-blood CD3+ cells
  • Patients must be at least 28 days out from allogeneic HCT at the time of enrollment; in general, patients should be no more than 60 days out from allogeneic HCT at time of enrollment; however, patients more than 60 days out from allogeneic HCT may be considered for enrollment in discussion with the protocol investigator (Dr. Maloney)
  • Patients must be enrolled on an FHCRC non-myeloablative allogeneic transplant protocol (not standard treatment plan); for eligibility purposes, "non-myeloablative" is defined here as conditioning therapy consisting of =< 4 Gy total body irradiation, with or without fludarabine
  • Patients with prior exposure to brentuximab vedotin are eligible for enrollment on this trial, regardless of previous disease response
  • Women of childbearing age and men with female partners of childbearing age must be willing and able to use an effective method of contraception during the study and for at least 30 days after the last study dose of brentuximab vedotin
  • Patients must be able to give informed consent

Who cannot join

  • Patients who are seropositive for human immunodeficiency virus (HIV)
  • Women who are pregnant or breast-feeding
  • Patients with moderate to severe peripheral neuropathy (grade 2 or higher); patients with a history of moderate/severe peripheral neuropathy may be enrolled if their neuropathy improves to =< grade 1 at the time of enrollment
  • Patients with significant hepatic dysfunction, as manifested by a total serum bilirubin > 4.0 g/dL; or clinical evidence of decompensated hepatic failure; or clinical evidence of decompensated portal hypertension
  • Patients with an absolute neutrophil count of < 1,000 cells/mm^3
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status of > 2
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  • Patients with a serum creatinine > 3.0 mg/dL
  • Patients with known hypersensitivity to brentuximab vedotin or any excipient contained in the drug formulation
  • Patients currently receiving treatment with other systemic anti-neoplastic or investigational agents targeting their CD30+ hematologic malignancy
  • Patients with active and uncontrolled infection not responding to appropriate treatment should be discussed with the study investigator (Dr. Maloney) before enrollment
  • Patients who have received donor lymphocyte infusion for low donor chimerism or pending graft rejection are not eligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Maintenance Therapy With Brentuximab Vedotin (SGN-35) After Allogeneic Hematopoietic Cell Transplantation for Hodgkin Lymphoma and CD30+ Hematologic Malignancies

This phase I/II trial studies the side effects and best way to give brentuximab vedotin and to see how well it works after donor stem cell transplant in treating patients with hematologic malignancies. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Monoclonal antibodies may kill cancer cells that are left after donor stem cell transplant.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the incidence of durable donor hematopoietic engraftment (defined by donor T-cell chimerism > 50% at day +84 after hematopoietic cell transplantation [HCT]) after allogeneic HCT and post-transplant brentuximab vedotin.

SECONDARY OBJECTIVES:

  1. Rates of complete and partial response; incidence of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD; overall and progression-free survival; rates of serious adverse events associated with brentuximab vedotin.

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Being tested
brentuximab vedotin, laboratory biomarker analysis, pharmacological study
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • brentuximab vedotinDrug

    Also called Adcetris, anti-CD30 ADC SGN-35, anti-CD30 antibody-drug conjugate SGN-35, antibody-drug conjugate SGN-35

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT01620229
Study groupRoleWhat they receive
Treatment (brentuximab vedotin)ExperimentalPatients receive brentuximab vedotin IV on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: brentuximab vedotin; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

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

  1. Incidence of durable hematopoietic engraftment defined as the achievement of > 50% donor CD3+ cell chimerism

    Evaluated according to the allogeneic transplant protocol on which patients are co-enrolled, or according to institutional standard practice if no monitoring scheme is specified in the transplant protocol.

    Measured: At day 84 after HCT

Secondary outcomes (7)

  1. Rates of relapse

    Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.

    Measured: Up to 5 years

  2. Non-relapse mortality

    Response criteria will be based on the 2007 revisions to the International Working Group criteria for malignant lymphoma.

    Measured: Up to 5 years

  3. Incidence of acute GVHD

    Measured: Up to 5 years

  4. Peak grade of acute GVHD

    Measured: Up to 5 years

  5. Incidence of chronic GVHD

    Measured: Up to 5 years

  6. Severity of chronic GVHD

    Measured: Up to 5 years

  7. Incidence of adverse events related to brentuximab vedotin, graded according to National Cancer Institute Common Toxicity Criteria version 4

    Measured: Up to 30 days after completion of study treatment

Timeline

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

  1. First posted15 Jun 2012 (estimated)
  2. Study startJun 2013
  3. Primary completionApr 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620229
Sponsor's protocol ID
2560.00
Other IDs
NCI-2012-00924, 2560.00, P30CA015704, P01CA018029
Status last verified
Apr 2014
First submitted
13 Jun 2012
Last updated
21 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing brentuximab vedotin, laboratory biomarker analysis and pharmacological study in people with Hematopoietic/Lymphoid Cancer, run by Fred Hutchinson Cancer Center at 1 site 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 12 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: withdrawn, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 durable hematopoietic engraftment defined as the achievement of > 50% donor CD3+ cell chimerism (time frame: At day 84 after HCT). 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 NCT01620229.

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 21 Apr 2014.

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