A Phase I/II Study of brentuximab vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
- Conditions
- Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma10025319
- Registration Number
- NL-OMON37406
- Lead Sponsor
- Millenium Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1. Male or female patients aged 2 to < 18 years (5 to < 18 years for patients with HL).;2. Have a 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 diagnosed with any relapsed or refractory CD30+ hematological malignancy [eg, primary mediastinal B-cell lymphoma] may be included in phase 1 of the study.);3. Patients with sALCL must have documented anaplastic lymphoma kinase (ALK) status.;4. Patients with HL must be in their second or 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.;5. Patients with relapsed or refractory sALCL must be beyond first remission or refractory to front-line chemotherapy.;6. Performance score >= 60 from Lansky Play Performance Scale if <= 16 years;7. Female patients who are of childbearing potential, agree to practice 2 effective
methods of contraception, at the same time, from the time of signing the informed
consent form (ICF) through 6 months after the last dose of study drug, or agree to
completely abstain from heterosexual intercourse;8. Male patients, even if surgically sterile, who agree to practice effective barrier
contraception during the entire study treatment period and through 6 months after the
last dose of study drug, or agree to completely abstain from heterosexual intercourse;9. Voluntary written consent (and institution-specific assent as appropriate based upon
patient comprehension) must be given before performance of any study-related
procedure not part of standard medical care, with the understanding that
consent/assent may be withdrawn by the patient or patient guardian at any time
without prejudice to future medical care.;10. Suitable venous access for the study-required procedures.;11. Clinical laboratory values as specified below within 14 days before the first dose of
study drug:
• Absolute neutrophil count greater than or equal to 1,500/µL.
• Platelet count greater than or equal to 75,000/µL.
• Serum bilirubin level less than or equal to 1.5 * upper limits of normal (ULN).
• Serum creatinine less than or equal to 1.5 * ULN.
• Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST
or SGOT) less than or equal to 2.5 * ULN.;12. Patients must have a radiographically or clinically evaluable tumor per the IWG(1)
criteria.
1. Current diagnosis of primary cutaneous ALCL those with systemic ALCL are
eligible.
2. Received an allogeneic stem cell transplant < 6 months prior to first dose of study
medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any
post-allogeneic transplant patient. (Prior PCR positivity that was successfully treated
is acceptable provided the baseline PCR result is negative prior to first dose of study
drug.)
3. Receiving immunosuppressive therapy.
4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is
allowed).
5. Previous treatment with any anti-CD30 antibody.
6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half lives.
7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery
disease, or arrhythmias, if this would, in the opinion of the investigator or medical
monitor, interfere with assessment of efficacy or safety of the drug.
8. 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)
9. Known cerebral/meningeal disease, including signs or symptoms of
progressive multifocal leukoencephalopathy (PML).
10. History of cirrhosis.
11. Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral
therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine
antimicrobial prophylaxis is acceptable).
12. Concurrent therapy with other anti-neoplastic or experimental agents.
13. System corticosteroid therapy <14 days prior to first dose of study medication.
14. Any serious underlying medical condition that, in the opinion of the investigator or
medical monitor, would impair patient*s ability to receive or tolerate the planned
treatment.
15. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient
contained in the drug formulation.
16. Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks
prior to first study dose.
17. Prior autologous hematopoietic stem cell infusion < 6 weeks prior to first study dose.
18. Grade 2 or greater unresolved toxicity from prior antineoplastic therapy.
19. Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints<br /><br>• Adverse events (AEs), serious adverse events (SAEs), assessments of clinical<br /><br>laboratory values, and vital sign measurements<br /><br>• Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and<br /><br>MMAE<br /><br>• Overall response rate (CR, PR) as determined by an IRF using PET, CT, and<br /><br>clinical assessment according to IWG revised response criteria</p><br>
- Secondary Outcome Measures
Name Time Method