Brentuximab Vedotin, Bendamustine, and Rituximab in Patients With Relapsed or Refractory B-cell N… (NCT02623920) | Clinical Trial Compass
WithdrawnPhase 2
Brentuximab Vedotin, Bendamustine, and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Stopped: Pharmaceutical company supplying the drug withdraw financial support. PI has decided to close study prior to enrollment of any patients.
United States0Started 2015-12-16
Plain-language summary
This phase II trial studies how well brentuximab vedotin, bendamustine, and rituximab work in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, use antibody to target chemotherapy in cancer cells. Drugs used in chemotherapy, such as bendamustine, work in different ways to kill cancer cells. Monoclonal antibodies, such as rituximab, kill the cancer cells directly, but also harness the immune system to kill the cancer cells. Adding brentuximab to rituximab may improve response rates in CD30 positive, CD20 positive Relapsed Refactory NHL.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* CD30 detectable B lineage relapsed refractory NHL including the following histologies:
* Aggressive lymphomas: diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, grey zone lymphomas, high grade B cell lymphomas, and transformed indolent lymphomas
* Indolent lymphoma: follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma; indolent lymphoma patients eligible for this trial should have high tumor burden and high risk disease, as defined by:
* The Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
* Intermediate or high risk by Follicular Lymphoma International Prognostic Index (FLIPI) score or elevated lactose dehydrogenase (LDH)/ beta-2 microglobulin (B2M)
* Subjects between 18 and 75 years old. Subjects older than 75 years old to be discussed with PI prior to subject consent; consensus between PI and treating physician is required.
* Karnofsky performance status (KPS) \>= 70%, Eastern Cooperative Oncology Group (ECOG) =\< 2
* At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
* Patients must have received at least one but no more than 4 prior lines of systemic therapy
* American Heart Association (AHA) class 1 without significant limitation of physical activity
* Ejection fraction (EF) of at least \>= 40% by multigated acquisition (MUGA) or echocardiography (ECHO)
* Total bilirubin =\< 1.5 mg/dl
* Alanine aminotransferase (ALT), aspartate aminotransf…
What they're measuring
1
CR rate
Timeframe: Up to 2 years after completion of study treatment
2
Percentage of patients obtaining a CR + PR using Cheson criteria
Timeframe: Up to 2 years after completion of study treatment