Clinical Trials /

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

NCT01492088

Description:

The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.

Related Conditions:
  • Anaplastic Large Cell Lymphoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Brentuximab Vedotin (SGN-35)</span> in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or <span class="go-doc-concept go-doc-disease">Hodgkin Lymphoma</span>

Title

  • Brief Title: Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
  • Official Title: A Phase 1/2 Study of Brentuximab Vedotin in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
  • Clinical Trial IDs

    NCT ID: NCT01492088

    ORG ID: C25002

    NCI ID: 2011-001240-29

    Trial Conditions

    Hodgkin Lymphoma

    Anaplastic Large-cell Lymphoma

    Trial Interventions

    Drug Synonyms Arms
    brentuximab vedotin SGN-35, ADCETRIS Arm 1

    Trial Purpose

    This is a phase 1/2, open-label, single-agent, multi-center, dose-escalation study of
    brentuximab vedotin in pediatric patients with relapsed or refractory systemic anaplastic
    large-cell lymphoma or Hodgkin lymphoma

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm 1 Experimental brentuximab vedotin brentuximab vedotin

    Eligibility Criteria

    Inclusion Criteria:

    - Male or female patients aged 2 to <18 years (5 to <18 years for Hodgkin lymphoma
    (HL))

    - Diagnosis of systemic anaplastic large-cell lymphoma, or Hodgkin lymphoma for which
    standard, curative, life-prolonging, or palliative treatment does not exist or is no
    longer effective

    - Patients with systemic anaplastic large-cell lymphoma (sALCL) must have documented
    anaplastic lymphoma kinase (ALK) status and must be beyond first remission or
    refractory to front-line chemotherapy

    - Patients diagnosed with any relapsed or refractory CD30+ hematologic malignancy
    (e.g., primary mediastinal B-cell lymphoma) may be included in phase 1 of the study

    - Patients with HL must be in their second of later relapse, have failed systemic
    chemotherapy either as induction therapy for advanced stage disease or salvage
    therapy, and were ineligible for, refused, or previously received a stem cell
    transplant

    - Performance score 60 from Lansky Play Performance Scale if < 16 years

    - Negative pregnancy test

    - Fertile patients must use 2 effective methods of contraception prior to and through 6
    months after the last dose of the study drug

    Exclusion Criteria:

    - Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible)

    - Received an allogeneic stem cell transplant <3 months prior to the first dose of
    study medication, or presence of polymerase chain reaction (PCR)-detectable
    cytomegalovirus (CMV) in any post-allogeneic transplant patient

    - Receiving immunosuppressive therapy

    - Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is
    allowed)

    - Previous treatment with any anti-CD30 antibody

    - Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma
    half-lives

    - Systemic cardiac disease that would, in the opinion of the investigator or medical
    monitor, interfere with assessment of efficacy or safety of the drug

    - History of another primary malignancy not in remission for at least 3 years (the
    following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical
    carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)

    - Known active cerebral/meningeal disease, including signs or symptoms of progressive
    multifocal leukoencephalopathy (PML) or any history of PML

    - History of cirrhosis

    - Active systemic viral, bacterial, or fungal infection requiring antimicrobial,
    antiviral therapy or antifungal therapy within 2 weeks prior to the first dose of
    study drug (routine antimicrobial prophylaxis is acceptable)

    - Concurrent therapy with other anti-neoplastic or experimental agents

    - Systemic corticosteroid therapy <7 days prior to first dose of the study medication

    - Any serious underlying medical condition that, in the opinion of the investigator or
    medical monitor, would impair their ability to receive or tolerate the planned
    treatment

    - Known hypersensitivity to recombinant proteins, murine proteins, or any excipient
    contained in the drug formulation

    - Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to
    the first study dose

    - Prior autologous hematopoietic stem cell infusion <4 weeks prior to first study dose

    - Grade 2 or greater unresolved toxicity from prior antineoplastic therapy

    - Grade 2 or greater peripheral neuropathy

    - Female patients who are both lactating and breastfeeding, or have a positive serum
    pregnancy test during the screening period or a positive urine pregnancy test on Day
    1 before the first dose of study drug

    - Received local palliative radiation therapy <14 days prior to the first dose of study
    medication

    - Received radiation therapy to more than 25% of the bone marrow-containing spaces < 84
    days prior to first dose of study medication

    - Received a strong or listed moderate inhibitor of CYP3A4 <2 weeks prior to first
    study dose

    - Patients must have fully recovered from the acute toxic effects of all prior
    chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    Minimum Eligible Age: 2 Years

    Maximum Eligible Age: 18 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Number of Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 1)

    Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 1)

    Overall response rate (CR, PR) as determined by an IRF using PET, CT, MRI and, clinical assessment according to IWG revised response criteria (phase 2)

    Secondary Outcome Measures

    Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer (phase 1 & phase 2)

    Overall response rate (CR, PR) as determined by an IRF using PET, CT, MRI and, clinical assessment according to IWG revised response criteria (phase 1)

    Time to progression (phase 1 & phase 2)

    Time to response (phase 1 & phase 2)

    Duration of response (phase 1 & phase 2)

    Event-free survival (phase 1 & phase 2)

    Progression-free survival (phase 1 & phase 2)

    Overall survival (phase1 and phase 2)

    Number of Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 2)

    Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 2)

    Trial Keywords

    Pediatric

    Lymphoma

    Hodgkin

    Anaplastic Large-cell

    Relapsed

    Refractory