None listed
Conditions
Brief summary
This study investigates the effectiveness and safety of the combination of Brentuximab vedotin and donor lymphocyte infusions for Hodgkin lymphoma that has relapsed or persists after an allogeneic stem cell transplant. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with CD30+ Hodgkin lymphoma in any remission status, for which you are undergoing allogeneic hematopoietic cell transplantation (alloHCT) OR are less than or equal to 60 days post-alloHCT from a matched related or unrelated adult donor. Study details All participants in this study will be monitored for relapse of Hodgkin lymphoma by positron emission tomography (PET) scans commencing 60 days after allogeneic transplant, and then 3 monthly thereafter. Upon identification of relapse of Hodgkin lymphoma, patients will receive treatment with brentuximab 1.8mg/kg every 3 weeks intravenously. After 3 doses of brentuximab, patients will also commence donor lymphocyte infusions at an initial dose of 1x10^6 T cells/kg intravenously, escalating to a maximum of 1x10^8 T cells/kg in a graded fashion. Donor lymphocyte infusions will be administered once every 3 weeks for a total of up to 5 infusions. Participants will undergo PET scans to assess response every 3 months for 24 months. This research will examine the effectiveness of treatment with the combination of brentuximab vedotin and donor lymphocyte infusions, which may be an important strategy for patients with Hodgkin lymphoma that relapses after allogeneic transplant.
Interventions
Participants will undergo a positron-emission tomography (PET) scan 60 days after allogeneic transplantation, and 3 monthly thereafter for 24 months.
Demonstration of persisting or relapsed Hodgkin lymphoma on PET scan after transplantation will initiate commencement of Brentuximab vedotin 1.8mg/kg by intravenous infusion every 3 weeks. Persisting or relapsed Hodgkin lymphoma will be defined as Deauville score 4 or 5, not attributed to other causes eg. infection or inflammation. Where possible,
Participants will undergo a positron-emission tomography (PET) scan 60 days after allogeneic transplantation, and 3 monthly thereafter for 24 months. Demonstration of persisting or relapsed Hodgkin lymphoma on PET scan after transplantation will initiate commencement of Brentuximab vedotin 1.8mg/kg by intravenous infusion every 3 weeks. Persisting or relapsed Hodgkin lymphoma will be defined as Deauville score 4 or 5, not attributed to other causes eg. infection or inflammation. Where possible, persisting or relapsed Hodgkin lymphoma on PET will be confirmed by tissue biopsy. After 3 doses of brentuximab (ie. 9 weeks), donor lymphocyte infusions will be administered by intravenous infusion commencing at an initial dose of 1x10^6 CD3+ cells/kg, escalating in graded increments to a maximum of 100x10^6 CD3+ cells/kg. DLI will be administered once every 3 weeks until a maximum of 100x10^6 CD3+ cells/kg are administered or until grade 2-4 acute GVHD develops. Increments of DLI will be: 1x10^6 CD3+ cells/kg 5x10^6 CD3+ cells/kg 10x10^6 CD3+ cells/kg 50x10^6 CD3+ cells/kg 100x10^6 CD3+ cells/kg Intervention fidelity will not be assessed in this study.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant must meet all the following criteria: 1. Age 18 years or older 2. Have a diagnosis of CD30+ Hodgkin lymphoma in any remission status 3. Undergoing or less than 60 days post-alloHCT from a matched related or unrelated adult donor
Exclusion criteria
Patients meeting any of the following exclusion criteria (at time of screening) are not to be enrolled in the study: 1. Prior exposure to brentuximab vedotin with less than PR or hypersensitivity reaction manifesting with anaphylaxis, Stevens-Johnson syndrome or toxic epidermal necrolysis or any adverse reaction attributed to brentuximab vedotin with severity greater than or equal to grade 2 2. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin 3. Any sensory or motor peripheral neuropathy greater than or equal to grade 2 4. Known cerebral or meninteal disease (Hodgkin lymphoma or any other aetiology) including signs or symptoms of progressive multifocal leukoencephalopathy 5. Knwon hepatitis B surface antigen positive, or known or suspected actuve hepatitis C infection 6. Knwon human immunodeficiency virus (HIV) exposure 7. Diagnosed or treated for another malignancy within 3 years before the first dose or previoiusly diagnosed with anther malignancy and have evidence of residual disease 8. Known history of any of the following cardiovascular conditions: myocardial infarction within 2 years of registration; class III or IV heart failure; evidence of uncontrolled cardovascular conditions; left venticular ejection fraction <50% 9. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol 10. Paatients that have had prior chemotherapy or other investigational agents within 5 half-lives of the last dose of that treatment 11. Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
Outcome results
None listed