Actively Recruiting
Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2020-12-10
37
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in responsive patients by high dose chemotherapy and ASCT.
CONDITIONS
Official Title
Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD30 positive diffuse large B-cell lymphoma (DLBCL) with more than 1% CD30 positive cells
- Primary refractory to or in first relapse after first line therapy with R-CHOP or similar treatment
- Age 18 years or older
- Measurable disease with at least one lesion larger than 1.5 cm and positive on PET scan
- WHO performance status between 0 and 2 (3 only if related to disease)
- Adequate liver function with bilirubin and liver enzymes within specified limits
- Adequate kidney function with GFR above 60 ml/min
- Adequate bone marrow function with sufficient neutrophil and platelet counts
- Hemoglobin level 8 g/dL or higher
- Eligible for high-dose chemotherapy and autologous stem cell transplantation
- Resolution of relevant toxicities from prior therapy
- Life expectancy longer than 3 months with treatment
- Negative pregnancy test if applicable
- Women must be post-menopausal, surgically sterile, or agree to effective contraception or abstinence
- Men must agree to use barrier contraception or abstain from heterosexual intercourse during the study and 12 months after
- Able and willing to provide informed consent
You will not qualify if you...
- Peripheral neuropathy grade 2 or higher
- Known brain or meningeal disease including progressive multifocal leukoencephalopathy
- Symptomatic neurological disease affecting daily living or requiring medication
- Transformed lymphoma
- DLBCL after organ transplantation
- Immunodeficiency-associated B-cell lymphoproliferative disease
- Use of other investigational drugs within 5 half-lives before study
- Recent myelosuppressive chemotherapy or biological therapy within 4 weeks
- Breastfeeding women
- Recent other malignancy within 3 years except certain skin or cervical cancers
- Known allergy to brentuximab vedotin components
- Active hepatitis B or C infection
- HIV infection
- Radiation therapy within 8 weeks prior to treatment start (except emergency cases)
- Serious psychiatric disorder interfering with treatment
- Major organ dysfunction not related to lymphoma
- Severe uncontrolled medical conditions including serious heart problems, impaired lung function, or thyroid issues
- Current participation in conflicting clinical trials
- Conditions that could affect study compliance or follow-up
- Claustrophobia preventing PET-CT imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Actively Recruiting
Research Team
P
P.J. Lugtenburg, Dr.
CONTACT
M
M. Minnema, Prof. dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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