ACTRN12619000581167
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Melbourne Health
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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