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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-13

Study Completion Date

2022-10-03

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (PET/CT, clonotype, metabolic profile)

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.

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

Given standard salvage chemotherapy

Computed Tomography

Intervention Type PROCEDURE

Undergo FDG-PET/CT scan

Fludeoxyglucose F-18

Intervention Type DRUG

Undergo FDG-PET/CT scan

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo FDG-PET/CT scan

Interventions

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Chemotherapy

Given standard salvage chemotherapy

Intervention Type DRUG

Computed Tomography

Undergo FDG-PET/CT scan

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Undergo FDG-PET/CT scan

Intervention Type DRUG

Positron Emission Tomography

Undergo FDG-PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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Chemo Chemotherapy (NOS) Chemotherapy, Cancer, General CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography 18FDG FDG fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Subject/legal representative willing and able to provide written informed consent
* Histologically confirmed aggressive B-cell DLBCL, including follicular lymphoma (FL) transforming to DLBCL and high grade B-cell lymphoma
* Willing to provide existing relapse-confirmatory DLBCL tumor sample
* Relapsed from or refractory to at least one treatment containing a CD20 monoclonal antibody combined with anthracycline-based chemotherapy
* CT scans showing involvement of 1 or more clearly demarcated lesions with a long axis \> 1.5 cm and short axis \>= 1.0 cm
* Baseline FDG-PET/CT scans must demonstrate at least one hypermetabolic lesion as defined by the Deauville criteria localizing to CT-defined anatomical tumor sites
* Suitable candidate for therapy with standard salvage chemotherapy and autologous stem cell transplant (ASCT) as determined by the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of \>= 12 weeks as estimated by the treating physician
* Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
* Hemoglobin \>= 8.5 g/dL
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 75,000/mm\^3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 x institutional upper limit of normal (ULN) for cases involving liver metastasis and =\< 3 x institutional ULN for all other cases
* Bilirubin =\< 2 x ULN (unless related to lymphoma) or =\< 5 x ULN for subjects with documented or suspected Gilbert's disease
* Serum creatinine =\< 1.5 x ULN or calculated creatinine clearance (CrCl) \>= 50 mL/min as determined by the Cockcroft-Gault equation

Exclusion Criteria

* 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 granulomatous disease
* Uncontrolled diabetes mellitus
* 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)
* Any chemotherapy, radiotherapy, immunotherapy, biologic, or investigational therapy for treatment of lymphoma within 14 days prior to treatment
* Symptomatic congestive heart failure

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No