Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma … (NCT01994850) | Clinical Trial Compass
CompletedPhase 1/2
Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma Patients
United States32 participantsStarted 2013-11
Plain-language summary
This is a Phase I/II multicenter single arm non-randomized open label study of the investigational drug, brentuximab vedotin, given in combination with routine chemotherapy (rituximab, cyclophosphamide, doxorubicin and prednisone) every 3 weeks for a total of 6 cycles.
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:
* Age 18 and above
* Histologically confirmed CD30-positive, CD20-positive untreated primary mediastinal B-cell lymphoma (any Ann Arbor stage), diffuse large B-cell lymphoma (Ann Arbor stage III or IV), or grey zone lymphoma (any Ann Arbor stage). Patients with heterogeneous, weak or equivocal CD30 staining will also be included (no specific cut off percentage for CD30 stain is required).
* Measurable disease, defined by the Revised Response Criteria for Malignant Lymphoma
* Absolute neutrophil count ≥1,000/mmᶟ and platelet count ≥75,000/µL(unless documented bone marrow involvement with lymphoma).
* Normal left ventricular ejection fraction of ≥50% estimated by MUGA scan or echocardiogram.
* Estimated creatinine clearance (using Cockcroft-Gault equation) must be \>50 mL/min.
* Serum bilirubin ≤1.5 x upper limit of normal (ULN). Bilirubin ≤ 3 x ULN is permitted in individuals with documented liver involvement by lymphoma or if due to known Gilbert syndrome.
* Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 3 x ULN.
* Performance status of ECOG 0-2; patients with ECOG of 3 may be allowed to enroll after discussion with the Regulatory-Sponsor/Principal Investigator and medical monitor, and if the performance status is believed to be secondary to lymphoma related symptoms and performance status is expected to improve once chemotherapy commences.
* Capable of understanding the investigational nature, potential risks and benefit…
What they're measuring
1
Number of Subjects With Dose-limiting Toxicities
Timeframe: 21 days (Cycle 1)
2
Overall Response Rate (ORR)
Timeframe: Three to five weeks after the completion of Cycle 6 (approximately 5 months after start if treatment)