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
2 other identifiers
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Oct 2015
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedStudy Start
First participant enrolled
October 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2022
CompletedOctober 28, 2022
October 1, 2022
7 years
March 27, 2015
October 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Response to therapy
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 Outcomes (3)
Response rate (RR)
Up to 18 months
Progression-free survival
Up to 18 months
Overall survival (OS)
Up to 18 months
Study Arms (1)
Diagnostic (PET/CT, clonotype, metabolic profile)
EXPERIMENTALPatients 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.
Interventions
Given standard salvage chemotherapy
Undergo FDG-PET/CT scan
Undergo FDG-PET/CT scan
Undergo FDG-PET/CT scan
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Cherng HJ, Chuang HH, Steiner R, Fayad L, Strati P, Nair R, Hagemeister F, Nastoupil LJ, Lee HJ, Neelapu SS, Flowers CR, Samaniego F, Rodriguez M, Macapinlac HA, Feng L, Westin J. A prospective study on early PET/CT scans during the first cycle of salvage chemotherapy for relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2022 Jan;63(1):74-83. doi: 10.1080/10428194.2021.1971223. Epub 2021 Aug 26.
PMID: 34435552DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Westin
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 1, 2015
Study Start
October 13, 2015
Primary Completion
October 3, 2022
Study Completion
October 3, 2022
Last Updated
October 28, 2022
Record last verified: 2022-10