NCT02405078

Tumor-Specific Clonotype, Metabolic Profile, and PET/CT in Predicting Chemotherapy Response in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies tumor-specific markers (clonotype), blood tests, and positron emission tomography (PET)/computed tomography (CT) in predicting treatment response at different times during chemotherapy in patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Studying samples of blood in the laboratory from patients during chemotherapy may help doctors learn more about the effects of treatment on cells and may help doctors determine whether patients are responding to treatment. PET/CT scan procedures are done at the same time with the same machine and the combined scans give more detailed pictures of areas inside the body than either scan gives by itself and may help doctors find out how well treatment is working.

Detailed description

PRIMARY OBJECTIVES: I. 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: I. To evaluate the optimal time points to create the diffuse large B-cell lymphoma (DLBCL) response prediction model. TERTIARY OBJECTIVES: I. To evaluate the prognostic value of clinical factors, cell of origin subtype, and circulating immune cell subsets for response to therapy. II. To evaluate for novel genomic aberrations or signatures which correlate with therapeutic failure. III. To evaluate the ability of additional positron emission tomography (PET)/computed tomography (CT) imaging interpretation techniques to correlate with clinical outcomes. IV. To evaluate the correlation of blood-based detection of clonotype with fludeoxyglucose F-18 (FDG) PET/CT disease assessment. V. To evaluate the utility of alternative methods of minimal residual disease detection. VI. To evaluate measurement of circulating metabolic profiling with imaging results and clinical outcomes. OUTLINE: Patients receive standard salvage chemotherapy as determined by the treating physician. Patients undergo FDG PET/CT scans at baseline (between days -21 to 0), on day 4 after completion of first high-dose chemotherapy, on day 21 after completion of the first course of chemotherapy, and on day 42 after the end of the second course of chemotherapy. Blood samples are also collected for tumor-specific clonotype and metabolic profile at baseline (days -5 to 0) and on days 4, 8, 21, and 42.

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chemotherapy	Given standard salvage chemotherapy
PROCEDURE	Computed Tomography	Undergo FDG-PET/CT scan
DRUG	Fludeoxyglucose F-18	Undergo FDG-PET/CT scan
PROCEDURE	Positron Emission Tomography	Undergo FDG-PET/CT scan

Timeline

• Start date: 2015-10-13
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2015-04-01
• Last updated: 2022-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study