Status:
NOT_YET_RECRUITING
CD30 Imaging in Diffuse Large B-cell Lymphoma
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Takeda
Conditions:
Diffuse Large B-cell-lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The antibody drug conjugate (ADC) brentuximab vedotin (BV), targeting CD30, is currently registered for the treatment of previously untreated stage III-IV Hodgkin lymphoma (HL), relapsed Hodgkin lymph...
Eligibility Criteria
Inclusion
- All patients with histologically proven CD30-positive (i.e. \> 1% cells) lymphomas who will be treated with BV, including:
- HL
- T-NHL
- CTCL
- DLBCL
- Age ≥18 years
- Signed written informed consent form (approved by the Institutional Review Board \[IRB\]/ Independent Ethics Committee \[IEC\]) obtained prior to any study specific screening procedures
- Measurable disease: on CT scan at least 1 lesion/node with a long axis of \> 1.5 cm and at least one positive lesion on 18F-FDG PET scan
- World Health Organization (WHO) performance status 0-2 (see appendix A)
- Adequate hepatic function: total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome as defined by \> 80% unconjugated bilirubin) and Alanine Aminotransferase (ALAT) / Aspartate Aminotransferase (ASAT) ≤ 3 times ULN (unless due to lymphoma involvement of the liver; in that case ALAT/ASAT may be elevated up to 5 times ULN)
- Adequate renal function: GFR \> 50 milliliter/ minute (ml/min) as estimated by the cockcroft \& gault formula at rehydration:
- Creatinine Clearance (CrCL) = (140-age \[in years\] x weight \[kg\] (x 0.85 for females) (0.815 x serum creatinine \[μmol/L\])
- Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/liter (L) and platelet count ≥100 x 109/L, unless caused by diffuse bone marrow infiltration by lymphoma
- Hemoglobin must be ≥ 8 g/dL (5.0 mmol/L), transfusion is allowed
- Life expectancy of \>3 months with treatment
- Negative pregnancy test at study entry, if applicable
Exclusion
- Prior allergic reaction or known hypersensitivity to immunoglobulins, recombinant proteins, murine proteins, or to any excipient contained in the dug formulation of BV.
- Peripheral sensory or motor neuropathy grade ≥ 2
- Patients with a serious psychiatric disorder that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol
- Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Claustrophobia to the extent that PET-CT is impossible
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06186986
Start Date
January 1 2024
End Date
January 1 2026
Last Update
January 2 2024
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