Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Diffuse… (NCT02541565) | Clinical Trial Compass
CompletedPhase 1
Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3b Follicular Lymphoma
United States30 participantsStarted 2015-11-24
Plain-language summary
This pilot phase I trial studies the side effects of pembrolizumab and combination chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab together with combination chemotherapy may be with a better treatment for diffuse large B-cell lymphoma or follicular lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma (of any stage); subjects must be planned to receive full course (6 cycles) of RCHOP chemoimmunotherapy as per clinical standard of care; patients may have de novo DLBCL, and /or any of the following:
* Composite lymphomas, which include both diffuse DLBCL and another histology (most commonly follicular lymphoma) in the same lymph node
* Transformed lymphoma with DLBCL histology, as long as the patient has not received prior therapy for lymphoma
* Discordant presentations, such as DLBCL in a lymph node and low-grade lymphoma such as follicular lymphoma in the bone marrow
* Be willing and able to provide written informed consent/assent for the trial
* Have measurable nodal disease, including at least 1 disease site measuring 1.5 cm in longest dimension on computed tomography (CT) or fludeoxyglucose (FDG)-positron emission tomography (PET)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)
* Absolute neutrophil count (ANC) \>= 1,500/mcL except in cases of marrow infiltration by lymphoma
* Platelets \>= 100,000/mcL except in cases of marrow infiltration by lymphoma
* Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L except in cases of marrow infiltration by lymphoma
* Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 60 ml/min for subject with creatinine levels \> 1…
What they're measuring
1
Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Timeframe: Up to 90 days after completion of study treatment