Study of Brentuximab Vedotin in Children and Adolescents With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
- Conditions
- Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin LymphomaMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001240-29-IT
- Lead Sponsor
- MILLENNIUM PHARMACEUTICALS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
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 postmenopausal for at least 1 year before the screening visit, OR • Are surgically sterile, OR • If they 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 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 8. 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. 9. Suitable venous access for the study-required procedures. 10. 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 x upper limits of normal (ULN). • Serum creatinine less than or equal to 1.5 x ULN. • Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST or SGOT) less than or equal to 2.5 x ULN. 11. Patients must have a radiographically or clinically evaluable tumor per the IWG(1) criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 42
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible). 2. Received an allogeneic stem cell transplant < 1 year 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. 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. Concurrent corticosteroid therapy at greater than or equal to 0.5 mg/kg or 10 mg/day prednisone. 14. 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. 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 < 8 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method