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New treatment option for DLBCL
Official title Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse
ClinicalTrials.gov ID: NCT03356054
What this study is testing
What is R-DHAP?
R-DHAP is an investigational medicine, being studied as a potential treatment for dlbcl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive(central pathology review results not required to enter patient into the study)...
- CD30 positive DLBCL, including EBV positive DLBCL
- CD30 positive primary mediastinal B-cell lymphoma
- Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy
- Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a...
You likely can't join if
- Peripheral sensory or motor neuropathy grade ≥ 2
- Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
- Symptomatic neurological disease compromising normal activities of daily living or requiring medications
- Transformed lymphoma
- DLBCL after organ transplantation
- Immunodeficiency-associated B-cell lymphoproliferative disease
See the full eligibility criteria
Who can join
- CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive(central pathology review results not required to enter patient into the study), according to the WHO classification 2008:
- CD30 positive DLBCL, including EBV positive DLBCL
- CD30 positive primary mediastinal B-cell lymphoma
- Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy
- Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a surgical biopsy is not possible, at least confirmation by FNA biopsy is...
- Refractory disease is defined as:
- progressive disease during first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required
- stable disease after at least 3 cycles of first line therapy, In this case biopsy confirmation of CD30 positive DLBCL is preferred but not required
- PR after at least 6 cycles of first line therapy, or in the case of stage I-II disease after at least 3 cycles of therapy and definitive involved field radiotherapy. In this case refractory disease must be...
- 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, status 3 only if disease related (see appendix C)
- Adequate hepatic function: total bilirubin ≤ 1.5 times ULN (unless due to lymphoma involvement of the liver or a known history of Gilbert's syndrome as defined by \> 80% unconjugated bilirubin) and ALAT/ASAT ≤ 3 times...
- Adequate renal function: GFR \> 60 ml/min as estimated by the Cockroft\&Gault formula at rehydration: 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) ≥ 1.5x109/L and platelet count ≥ 100 x 109/L, unless caused by diffuse bone marrow infiltration by the NHL
- Hemoglobin must be ≥ 8 g/dL (5.0 mmol/L), transfusion is allowed
- 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...
- 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...
- Written informed consent
- Patient is capable of giving informed consent
What rules you out
- Peripheral sensory or motor neuropathy grade ≥ 2
- Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
- 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
- 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...
- 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 as defined by positive serology and transaminitis. Non-active hepatitis B carriers or anti-HBc positive patients may be included if protected with lamuvidine or entecavir (see 9.4)
- 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 such as:
- Known history of symptomatic congestive heart failure (NYHA III, IV, appendix E), myocardial infarction ≤ 6 months prior to first study drug
- Evidence of current serious uncontrolled cardiac arrhythmia, angina pectoris, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \<45%
- Severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and/or O2 saturation that is 90% or less at...
- Thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication
- Current participation in another clinical trial interfering with this trial
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, Netherlands
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.