Trial purpose
Cancer treatment
Tumor type
Haematological
Clinical summary
Summary
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, participants 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.
Conditions
This trial is treating people with Hodgkin's lymphoma
Eligibility
Inclusion
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
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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Millennium Pharmaceuticals, Inc.,Royal Melbourne Hospital
Scientific Title
Efficacy of Positron Emission Tomography (PET) directed combination therapy with Brentuximab Vedotin and donor lymphocyte infusion in Hodgkin lymphoma relapsing or persisting after allogeneic haematopoietic stem cell transplantation
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