Pilot Project for Creation of the DLBCL Response Prediction Model: Combining Early Interim Functional Imaging, Detection Of A Tumor-Specific Clonotype and Metabolic Profiling of Blood Of In Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma To Predict Response To Standard Immunochemotherapy
Jason R. Westin
The goal of this clinical research study is to learn if performing blood tests and imaging scans at different time points during chemotherapy can help researchers predict if patients with DLBCL will respond to treatment.
Disease Group: Lymphoma
Treatment Agent: PET/CT
Treatment Location: Only at MD Anderson
Primary Objective 1) To evaluate the ability of blood based detection of a tumor-specific clonotype and metabolic profiling and functional imaging to predict response to standard immunochemotherapy Secondary Objectives 1) To evaluate the optimal time points to create the DLBCL Response Prediction Model Exploratory Objectives 1) To evaluate the prognostic value of clinical factors, cell of origin subtype, and circulating immune cell subsets for response to therapy 2) To evaluate for novel genomic aberrations or signatures which correlate with therapeutic failure 3) To evaluate the ability of additional PET/CT imaging interpretation techniques to correlate with clinical outcomes 4) To evaluate the correlation of blood-based detection of clonotype with FDG PET/CT disease assessment 5) To evaluate the utility of alternative methods of minimal residual disease detection 6)To evaluate measurement of circulating metabolic profiling with imaging results and clinical outcomes
IRB Review and Approval Date: 10/13/2015
Recruitment Status: Open
Projected Accrual: N/A
1) Age 18 years or older at the time of screening.
2) Subject/legal representative willing and able to provide written informed consent.
3) Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL.
4) Willing to provide existing relapse-confirmatory DLBCL tumor sample.
5) Relapsed from or refractory to at least one treatment containing rituximab combined with anthracycline-based chemotherapy.
6) CT scans showing involvement of 1 or more clearly demarcated lesions with a long axis > 1.5 cm and short axis >/=1.0 cm.
7) Baseline FDG PET/CT scans must demonstrate at least one hypermetabolic lesion as defined by the Deauville criteria (52) localizing to CT-defined anatomical tumor sites.
8) Suitable candidate for therapy with high-dose chemotherapy and ASCT as determined by the treating physician.
9) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
10) Life expectancy of >/=12 weeks as estimated by the treating physician.
11) Negative serum beta-human chorionic gonadotropin (Beta-hCG) test (women of childbearing potential only).
12) Adequate organ function defined as follows: Serum creatinine </= 1.5 × ULN or calculated creatinine clearance (CrCl) >/= 50 mL/min as determined by the Cockcroft-Gault equation.
1) Any condition that, in the opinion of the investigator, would
interfere with the interpretation of study results or subject safety
including non-malignant FDG avid diseases such as sarcoidosis or other
2) Uncontrolled diabetes mellitus.
3) Concurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed).
4) History of serious allergy or reaction to any component of RICE or RDHAP formulations that would prevent administration.
Information and next steps
Jason R. Westin
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