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New treatment option for Hodgkin Lymphoma
Official title BrECADD Therapy in Stage 2 B-IV Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07002216
What this study is testing
What is Brentuximab Vedotin?
Brentuximab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hodgkin lymphoma.
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
- The purpose of this study is to further assess the efficacy and tolerability of a regimen of Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone (BrECADD) in patients with Stage 2 B-IV Hodgkin Lymphoma (HL) with an exploratory objective to assess the clinical utility of Circulating tumor DNA (ctDNA) as a biomarker for minimal residual disease (MRD) and depth of treatment response.
- 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 to 60
You may be able to join if
- Men and women ≥18 years of age and ≤60 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction...
- Patients must have histologic confirmation of classical Hodgkin Lymphoma (cHL) defined by the World Health Organization (WHO) classification.
- Baseline Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Computed Tomography (CT) must demonstrate Fluorodeoxyglucose (FDG) avid lesions...
- Patients must have a clinical stage consistent with: a. Stage 2 B cHL with one or both of the following risk factors: i. Large mediastinal mass (≥1/3...
- Eastern Cooperative Oncology Group (ECOG) performance score (PS)≤ 2, except due to lymphoma involvement.
You likely can't join if
- Stage I or Stage IIA (IIA) HL.
- Nodular lymphocyte-predominant HL.
- Prior systemic lymphoma therapy including prior treatment with brentuximab vedotin. Note: Patients with prior treatment for indolent lymphoma are...
- Any uncontrolled or clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening;
- Unstable angina within 3 months before screening;
See the full eligibility criteria
Who can join
- Men and women ≥18 years of age and ≤60 years of age on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Patients must have histologic confirmation of classical Hodgkin Lymphoma (cHL) defined by the World Health Organization (WHO) classification.
- Baseline Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Computed Tomography (CT) must demonstrate Fluorodeoxyglucose (FDG) avid lesions compatible with computed tomography (CT)-defined anatomical tumor...
- Patients must have a clinical stage consistent with: a. Stage 2 B cHL with one or both of the following risk factors: i. Large mediastinal mass (≥1/3 of the maximum transverse thoracic diameter) ii. Extranodal disease...
- Eastern Cooperative Oncology Group (ECOG) performance score (PS)≤ 2, except due to lymphoma involvement.
- Life expectancy ≥3 months.
- Women should avoid becoming pregnant for the full duration of chemotherapy and for up to 6 months after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures...
- Female patients of childbearing potential must use highly effective methods of contraception.
- Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.
- A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral...
- A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.
- Male patients with a female partner of childbearing potential are eligible if they abstain from sexual intercourse, are vasectomized, or if they agree to the use of barrier contraception with other methods described...
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) \>1,000 cells/mm3 independent of growth factor support within 7 days of study entry (≥750 cells/mm3 if lymphoma involvement of the bone marrow or spleen).
- Platelets ≥75,000 platelets/mm3 independent of transfusion support within 7 days of study entry (≥50,000 platelets/mm3 independent of transfusion support within 7 days of study entry if lymphoma involvement of the bone...
- Hemoglobin \>9 g/dL or \>8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry.
- Serum total bilirubin ≤2x upper limit of normal (ULN; except patients with Gilberts syndrome).
- Aspartate aminotransferase (AST; serum glutamic-oxaloacetic transaminase) and alanine transaminase (ALT; serum glutamic-pyruvic transaminase) ≤2.5x institutional ULN (≤3x institutional ULN if lymphoma involvement of the...
- Creatinine within normal institutional limits or creatinine clearance ≥40 mL/min (as estimated by the Cockcroft-Gault equation or alternative formula according to institutional guidelines) for patients with creatinine...
- Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments (SoA).
What rules you out
- Stage I or Stage IIA (IIA) HL.
- Nodular lymphocyte-predominant HL.
- Prior systemic lymphoma therapy including prior treatment with brentuximab vedotin. Note: Patients with prior treatment for indolent lymphoma are still eligible for participation as long as they did not receive...
- Any uncontrolled or clinically significant cardiovascular disease including the following:
- Myocardial infarction within 6 months before screening;
- Unstable angina within 3 months before screening;
- New York Heart Association class III or IV congestive heart failure;
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- Uncontrolled hypertension as indicated by ≥2 consecutive blood pressure measurements showing systolic blood pressure \>170 mm Hg and/or diastolic blood pressure \>105 mm Hg at screening.
- Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).
- Uncontrolled concurrent illness, such as liver cirrhosis, diabetes, autoimmune disorder requiring immunosuppression or long-term corticosteroids (\>10 mg daily prednisone equivalent), or any other serious medical...
- Severe or debilitating pulmonary disease.
- Peripheral neuropathy ≥Grade 2.
- Concurrent malignancy requiring active therapy.
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6...
- Active fungal, bacterial and/or viral infection requiring systemic therapy.
- Breastfeeding or pregnant women.
- Known active infection with human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection as follows:
- Patients with positive HIV test and undetectable viral load will be eligible for this study.
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb): Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\<20 IU), and if...
- Presence of hepatitis C virus (HCV) antibody: Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable.
- Patients with impaired decision-making capacity.
- Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.
- Patients undergoing major surgery ≤4 weeks prior to receiving their first dose of BrECADD. Major surgery is defined as open-heart, reconstructive, transplant, removal of a brain tumor, or a damaged kidney surgery.
- Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.
- Hypersensitivity to brentuximab vedotin, any components of the BrECADD regimen, or any of the other ingredients of the applicable study medications.
- Concurrent participation in another therapeutic clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
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 to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. 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.