- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
Given standard salvage chemotherapy
Other Names:
Undergo FDG-PET/CT scan
Other Names:
Undergo FDG-PET/CT scan
Other Names:
Undergo FDG-PET/CT scan
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to therapy
Time Frame: Up to 42 days
|
Defined as demonstrating the chemotherapy-sensitiveness for curative autologous stem cell transplant (ASCT) based on fludeoxyglucose F 18 FDG positron emission tomography (PET)/computed tomography (CT) results.
Non-responders will be classified as having equivocal active disease with a positive biopsy for confirmation and unequivocal active disease in a previously biopsy-confirmed site of disease.
Descriptive statistics will be used to summarize the demographic and clinical characteristics of patients.
The concordance rate between the interim PET/CT scans and the final FDG PET/CT scan, and its 95% confidence interval, will be reported.
The change in drug of choice (DoC) and metabolic profile tests will be explored using mixed effect linear regression models.
|
Up to 42 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate (RR)
Time Frame: Up to 18 months
|
RR will be analyzed using multivariate logistic regression.
|
Up to 18 months
|
Progression-free survival
Time Frame: Up to 18 months
|
The association between FDG PET/CT scans, DoC and metabolic profile tests, and the progression-free from primary treatment failure will be examined using a stratified Cox regression model.
|
Up to 18 months
|
Overall survival (OS)
Time Frame: Up to 18 months
|
The association between FDG PET/CT scans, DoC and metabolic profile tests, and the OS from primary treatment failure will be examined using a stratified Cox regression model.
|
Up to 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason Westin, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
- Deoxyglucose
Other Study ID Numbers
- 2015-0022 (Other Identifier: M D Anderson Cancer Center)
- NCI-2015-01946 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Diffuse Large B-Cell Lymphoma
-
Fred Hutchinson Cancer CenterNektar TherapeuticsRecruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent Grade 3b Follicular Lymphoma | Refractory Grade 3b Follicular... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingRecurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent Diffuse Large B-Cell... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterADC TherapeuticsWithdrawnRecurrent Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Recurrent High... and other conditionsUnited States
-
Nathan DenlingerBristol-Myers SquibbRecruitingB-Cell Non-Hodgkin Lymphoma-Recurrent | Diffuse Large B-Cell Lymphoma-Recurrent | Follicular Lymphoma-Recurrent | High Grade B-Cell Lymphoma-Recurrent | Primary Mediastinal Large B-Cell Lymphoma-Recurrent | Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent and other conditionsUnited States
-
David Bond, MDRecruitingRecurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal Large B-Cell Lymphoma | Refractory Primary Mediastinal Large B-Cell LymphomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent Transformed B-Cell Non-Hodgkin Lymphoma | Refractory Transformed B-Cell Non-Hodgkin Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma | Refractory Primary Mediastinal (Thymic)... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Recurrent Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma | Recurrent... and other conditionsUnited States
-
Jonsson Comprehensive Cancer CenterRecruitingProgressive Disease | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma | Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | Refractory High Grade B-Cell Lymphoma | Refractory Transformed Follicular... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingRecurrent Diffuse Large B-Cell Lymphoma | Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma | Recurrent High Grade B-Cell... and other conditionsUnited States
Clinical Trials on Chemotherapy
-
University of WashingtonNational Cancer Institute (NCI)CompletedAdult Acute Myeloid Leukemia | Adult Myelodysplastic SyndromeUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingColorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Colorectal Carcinoma Metastatic in the LungUnited States, Canada
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
International Atomic Energy AgencyCompletedNon Small Cell Lung CancerChile, China, Croatia, Egypt, India, Malaysia, Malta, Morocco, Pakistan, Panama, Peru, South Africa, Tunisia
-
Ping LiangNot yet recruitingChemotherapy | Liver Metastases | Colorectal Carcinoma
-
Second Affiliated Hospital, School of Medicine,...UnknownUnresectable Gastric Cancer | Successful Conversion Rate of OperationChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Yantai Yuhuangding HospitalRecruiting
-
Shenzhen SiBiono GeneTech Co.,LtdUnknown
-
Ruijin HospitalNot yet recruitingGastric Cancer | Neoadjuvant ChemotherapyChina