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

This study is currently recruiting participants.
Verified September 2013 by Millennium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01492088
First received: December 12, 2011
Last updated: September 6, 2013
Last verified: September 2013

December 12, 2011
September 6, 2013
April 2012
January 2016   (final data collection date for primary outcome measure)
  • Number of Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 1) [ Time Frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 12 months ] [ Designated as safety issue: Yes ]
    To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin
  • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 1) [ Time Frame: All (21 day) Cycles: Day 1; Cycle 1: Days 2, 3, 5, 14; Cycle 2: Days 2 (phase 1 only), 3, 5; Cycle 8: Days 2, 3, 5, 14 ] [ Designated as safety issue: No ]
    Pharmacokinetics of brentuximab vedotin
  • Number of patients with overall response as determined by an IRF using PET, CT, MRI and, clinical assessment according to IWG revised response criteria (phase 2) [ Time Frame: PET: At Screening, Cycles 2 and 7. No additional scans needed after Cycle 7 unless clinically indicated. CT scans and MRI: Screening, Cycle 2, 4, 7, 10, 13, 16 and end of treatment and every 12 weeks thereafter for 12 months ] [ Designated as safety issue: No ]
    Complete response + partial response
  • Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 1) [ Time Frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 12 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 1) [ Time Frame: All (21 day) Cycles: Day 1; Cycle 1: Days 2, 3, 5, 14; Cycle 2: Days 2 (phase 1 only), 3, 5; Cycle 8: Days 2, 3, 5, 14 ] [ Designated as safety issue: No ]
    Pharmacokinetics of brentuximab vedotin
  • Number of patients with overall response as determined by an IRF using PET, CT and, clinical assessment according to IWG revised response criteria (phase 2) [ Time Frame: PET: At Screening, Cycles 2 and 7. No additional scans needed after Cycle 7 unless clinically indicated. CT: Screening, Cycle 2, 4, 7, 10, 13, 16 and end of treatment and every 12 weeks thereafter for 12 months ] [ Designated as safety issue: No ]
    Complete response + partial response
Complete list of historical versions of study NCT01492088 on ClinicalTrials.gov Archive Site
  • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer (phase 1 & phase 2) [ Time Frame: At screening, predose Day 1 at Cycle 2 and Cycle 4, and at end of treatment; approximately 28 months ] [ Designated as safety issue: No ]
    Immunogenicity of brentuximab vedotin
  • Number of patients with overall response as determined by an IRF using PET, CT, MRI and, clinical assessment according to IWG revised response criteria (phase 1) [ Time Frame: PET: At Screening, Cycles 2 and 7. No additional scans needed after Cycle 7 unless clinically indicated. CT scans and MRI: Screening, Cycle 2, 4, 7, 10, 13, 16 and end of treatment and every 12 weeks therafter for 12 months ] [ Designated as safety issue: No ]
    Complete response + partial response
  • Time to progression (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease, approximately 40 months ] [ Designated as safety issue: No ]
  • Time to response (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documentation of a confirmed complete or partial response, approximately 12 months ] [ Designated as safety issue: No ]
  • Duration of response (phase 1 & phase 2) [ Time Frame: From the date of first documentation of a confirmed response to the date of progressive disease, approximately 12 months ] [ Designated as safety issue: No ]
  • Number of patients with event-free survival (phase 1 & phase 2) [ Time Frame: Duration of study (up to 16 cycles) and for 12 months following last dose; approximately 40 months ] [ Designated as safety issue: No ]
  • Number of patients with progression-free survival (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease or death, approximately 40 months ] [ Designated as safety issue: No ]
  • Number of patients with overall survival (phase 2) [ Time Frame: From the first dose of study treatment to date of death, approximately 40 months ] [ Designated as safety issue: No ]
  • Number of Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 2) [ Time Frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 12 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 2) [ Time Frame: All Cycles: Day 1; Cycle 1: Days 2, 3, 5, 14; Cycle 2: Days 2 (phase 1 only), 3, 5; Cycle 8: Days 2, 3, 5, 14 ] [ Designated as safety issue: No ]
    Pharmacokinetics of brentuximab vedotin
  • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer (phase 1 & phase 2) [ Time Frame: At screening, predose Day 1 at Cycle 2 and Cycle 4, and at end of treatment; approximately 28 months ] [ Designated as safety issue: No ]
    Immunogenicity of brentuximab vedotin
  • Number of patients with overall response as determined by an IRF using PET, CT and, clinical assessment according to IWG revised response criteria (phase 1) [ Time Frame: PET: At Screening, Cycles 2 and 7. No additional scans needed after Cycle 7 unless clinically indicated. CT: Screening, Cycle 2, 4, 7, 10, 13, 16 and end of treatment and every 12 weeks therafter for 12 months ] [ Designated as safety issue: No ]
    Complete response + partial response
  • Time to progression (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease, approximately 40 months ] [ Designated as safety issue: No ]
  • Time to response (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documentation of a confirmed complete or partial response, approximately 12 months ] [ Designated as safety issue: No ]
  • Duration of response (phase 1 & phase 2) [ Time Frame: From the date of first documentation of a confirmed response to the date of progressive disease, approximately 12 months ] [ Designated as safety issue: No ]
  • Number of patients with event-free survival (phase 1 & phase 2) [ Time Frame: Duration of study (up to 16 cycles) and for 12 months following last dose; approximately 40 months ] [ Designated as safety issue: No ]
  • Number of patients with progression-free survival (phase 1 & phase 2) [ Time Frame: From the first dose of study treatment to the date of first documented progressive disease or death, approximately 40 months ] [ Designated as safety issue: No ]
  • Number of patients with overall survival (phase 2) [ Time Frame: From the first dose of study treatment to date of death, approximately 40 months ] [ Designated as safety issue: No ]
  • Adverse events, serious adverse events, assessments of clinical and laboratory values, and vital sign measurements (phase 2) [ Time Frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 12 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and monomethyl auristatin E (MMAE) (phase 2) [ Time Frame: All Cycles: Day 1; Cycle 1: Days 2, 3, 5, 14; Cycle 2: Days 2 (phase 1 only), 3, 5; Cycle 8: Days 2, 3, 5, 14 ] [ Designated as safety issue: No ]
    Pharmacokinetics of brentuximab vedotin
Not Provided
Not Provided
 
Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
A Phase 1/2 Study of Brentuximab Vedotin in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

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

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hodgkin Lymphoma
  • Anaplastic Large-cell Lymphoma
Drug: brentuximab vedotin
Brentuximab vedotin will be administered by intravenous (IV) infusion once every 21 days. Each 21-day treatment cycle is composed of 1 day study drug treatment, followed by a monitoring period of 20 days. Patients may receive brentuximab vedotin for up to 16 cycles. Treatment with brentuximab vedotin beyond 16 cycles may be allowed for responding patients after discussion between the investigator and medical monitor. Following the final dose of brentuximab vedotin patients will be monitored for safety for a minimum of 30 days or until receipt of another treatment for lymphoma, whichever comes first. Patients will be followed for 12 months following the last dose of brentuximab vedotin to assess overall survival.
Other Name: SGN-35
Experimental: Arm 1
brentuximab vedotin
Intervention: Drug: brentuximab vedotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
April 2016
January 2016   (final data collection date for primary outcome measure)

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 effective 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 <6 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)
  • 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 <14 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 <6 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 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
Both
2 Years to 18 Years
No
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com
United States,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT01492088
C25002, 2011-001240-29
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP