Brentuximab Vedotin in combination with donor lymphocyte infusions for Hodgkin lymphoma relapsing or persisting after allogeneic stem cell transplantatio

Phase 2

Recruiting

• Conditions: Hodgkin lymphoma; Cancer - Hodgkin's

• Registration Number: ACTRN12619000581167
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified