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: 17.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10065864Term: Anaplastic large-cell lymphoma, primary systemic typeSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001240-29-NL
- 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 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 through 6 months after the last dose of study drug, or
. • Agree to practice true abstinence, when this is in line with the
preferred and usual lifestyle of the subject. (Periodic abstinence [eg,
calendar, ovulation, symptothermal, postovulation methods] and
withdrawal are not acceptable methods of contraception.)
8. Male patients, even if surgically sterilized (ie, status postvasectomy),
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 practice true abstinence, when this is in line with the
preferred and usual lifestyle of the subject. (Periodic abstinence [eg,
calendar, ovulation, symptothermal, postovulation methods for the
female partner] and withdrawal are not acceptable methods of
contraception.)
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 4 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) or less than or equal to 3 ? ULN for patients with an
indirect hyperbilirubinemia due to Gilbert's disease.
• 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. AST and ALT levels may be elevated up to 5 ? ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in the liver.
12. 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 y
1. Current diagnosis of primary cutaneous ALCL (those with sALCL are eligible).
2. Received an allogeneic stem cell transplant <3 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 halflives.
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 active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of 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. Systemic corticosteroid therapy <7 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 the 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 ?4 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. (Strong
inhibitors of CYP3A4 are listed in Appendix 14.4.) (Please refer to the Study Manual for an
example list of prohibited CYP3A4 inhibitors.)
20. Grade 2 or greater peripheral neuropathy.
21. Female patients who are both lactating and breastfeeding, or have a
positive serum or urine pregnancy test during the screening period or a positive serum or urine pregnancy test on Day 1 before the first dose of study drug.
22. Received local palliative radiation therapy < 14 days prior to the first dose of study
medication.
23. Received radiation therapy to more than 25% of the bone marrow-containing spaces
< 84 days prior to first dose of study medication.
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