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Transplant BRaVE NHL: Phase I-II study combining Brentuximab Vedotin with second line salvage chemotherapy (R-DHAP) in CD30 positive diffuse large B-cell lymphoma patients refractory to first line chemotherapy or in first relapse who are eligible for high dose treatment followed by autologous stem cell transplantation. Transplant BRaVE NHL
EU CTIS ID: 2023-510556-22-00
What this study is testing
Phase 1 part: - To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAP Phase 2 part: - To evaluate the efficacy of the combination of brentuximab -vedotin and R-DHAP as salvage treatment in relapse/refractory DLBCL patients in terms of metabolic CR rate after the third cycle - To establish the rate of CTCAE grade 3/4 non-hematological toxicity, including neurotoxicity after each cycle of brentuximab vedotin-R-DHAP
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive according to the WHO classification 2008: CD30 positive DLBCL, including EBV positive DLBCL. CD30 positive primary mediastinal B-cell lymphoma
- Eligible for high-dose chemotherapy and ASCT
- Resolution of relevant toxicities from first-line therapy
- Life expectancy of > 3 months with treatment
- Negative pregnancy test at study entry, if applicable
- Female patient is either post-menopausal for at least 1 year before screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, or agrees to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months after the last dose of study drug
You likely can't join if
- Peripheral sensory or motor neuropathy grade ≥ 2
- History of another malignancy less than 3 years before study inclusion, or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
- Active hepatitis B or C infection
- HIV positivity
- Radiation therapy within 8 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists
See the full eligibility criteria
Who can join
- CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive according to the WHO classification 2008: CD30 positive DLBCL, including EBV positive DLBCL. CD30 positive primary mediastinal B-cell lymphoma
- Eligible for high-dose chemotherapy and ASCT
- Resolution of relevant toxicities from first-line therapy
- Life expectancy of > 3 months with treatment
- Negative pregnancy test at study entry, if applicable
- Female patient is either post-menopausal for at least 1 year before screening visit or surgically sterile or if of childbearing potential, agrees to practice 2 effective methods of contraception, at the same time, or agrees to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months after the last dose of study drug
- Male patients, even if surgically sterilized, (i.e. status post vasectomy) agree to practice effective barrier contraception, or agrees to completely abstain from heterosexual intercourse, during the entire study period and through 12 months after the last dose of study drug
- Written informed consent
- Patient is capable of giving informed consent
- Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy
- Age ≥ 18 years (upper age limit for ASCT at the discretion of the participating center)
- 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
- WHO performance status 0-2
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
- Hemoglobin must be ≥ 8 g/dL (5.0 mmol/L), transfusion is allowed
What rules you out
- Peripheral sensory or motor neuropathy grade ≥ 2
- History of another malignancy less than 3 years before study inclusion, or previously diagnosed with another malignancy and have evidence of residual disease, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of the uterine cervix
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
- Active hepatitis B or C infection
- HIV positivity
- Radiation therapy within 8 weeks prior to start of protocol treatment. Emergency radiation therapy is allowed, as long as measurable disease (at non-irradiated sites) persists
- Patients with a serious psychiatric disorder that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol
- Major organ dysfunction, unless NHL-related
- Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study
- Thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication
- Current participation in another clinical trial interfering with this trial
- Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
- 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
- Symptomatic neurological disease compromising normal activities of daily living or requiring medications
- Transformed lymphoma
- DLBCL after organ transplantation
- Immunodeficiency-associated B-cell lymphoproliferative disease
- Use of other investigational agents within at least 5 half-lives of the most recent agent used prior to study entry
- Treatment with myelosuppressive chemotherapy or biological therapy ≤ 4 weeks before study entry
- Female patients who are breast feeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.