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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03681535
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):
Duke University

Brief Summary:

This phase II study will evaluate whether a reduction in radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity .

Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET-CT scan following rituximab - containing chemotherapy.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Radiation: Radiation Therapy Not Applicable

Detailed Description:

Chemotherapy followed by consolidation radiation therapy (RT) is a recognized treatment paradigm for DLBCL. This was initially established based on the results of 2 randomized trials conducted in the 1980s-1990s. In these studies patients were treated with 30Gy after chemotherapy (ECOG study) or 40-55Gy (SWOG study). A British National Lymphoma Investigation study showed no difference in freedom from local progression, progression-free survival or overall survival in between patients receiving 30Gy and 40-45Gy. Additionally systemic therapy for DLBCL has significantly improved since these initial studies, with the addition of rituximab to standard chemotherapy.

In a phase II study at Duke University patients with DLBCL NOS or primary mediastinal B-cell lymphoma were treated to 19.5-20Gy after achieving complete response to 4-6 cycles of chemotherapy containing rituximab. With a median follow-up of 43 months, there was only 1 local recurrence. The 5-year local control rate was 98%. Progression-free and overall survival at 5 years was 81% and 88%. Therefore, there is emerging evidence of long term favorable outcomes in localized DLBCL, while decreasing the risk of late effects by reducing the dose and volume of RT.

All participants will receive 20Gy instead of 30-36Gy after completion of at least 3 cycles of rituximab with combination chemotherapy. Participants must have a negative post chemotherapy PET-CT to participate in this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Single arm interventional study
RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments).
Radiation: Radiation Therapy
This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve complete response and have a negative post-chemotherapy PET scan following 3 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.

Primary Outcome Measures :
  1. Local control rate [ Time Frame: 5 years ]
    Local control rate of 95% measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
    Disease-free survival (DFS) will be defined as the time from on-study to first disease progression or death due to any cause, whichever comes first.

  2. Overall Survival [ Time Frame: 5 years ]
    Overall survival will be defines as the time from on-study to death due to any cause.

  3. Patterns of failure [ Time Frame: 5 years ]
    To examine patterns of failure we, we will tabulate the various ways that patients failed, up until the time of analysis. For example, these ways will include local only, local + distant, and distant only.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic documentation of stage I-IV diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), as defined by the 2016 WHO classification. This would include all entities within this category including germinal center B-cell and non-germinal center B-cell subtypes and those with a double expressor phenotype. Also eligible are stage I-IV high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements and high-grade B-cell lymphoma, NOS
  • Completion of at least 3 cycles of rituximab-containing, anthracycline-based combination chemotherapy
  • Negative post-chemotherapy PET-CT scan or negative interim PET-CT scan performed within 2 weeks of the final cycle of chemoimmunotherapy. This is defined as a score of 1-3 on the PET Five Point (Deauville) Scale using the Modified Lugano Response Criteria for Non-Hodgkin's Lymphoma
  • Absolute neutrophil count greater than 1000 and platelet count greater than 40,000
  • Negative pregnancy test in women of child-bearing potential
  • Signed study specific informed consent

Exclusion Criteria:

  • Primary central nervous system lymphoma, primary cutaneous DLBCL, leg type. T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, or other distinct non-Hodgkin lymphomas arising from large B-cells included in the WHO classification
  • Any absolute contraindications to irradiation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03681535

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Contact: Tykeytra Dale, BSN MS 919-668-3726
Contact: Jennifer Mewshaw, MS NP 919 668 5211

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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Boyle    617-582-8918   
Principal Investigator: Andrea Ng, MD MPH         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015   
Principal Investigator: Scott Stafford M.D. (Rochester MN)         
Sub-Investigator: William G Rule M.D. (Scottsdale AZ)         
Sub-Investigator: Jennifer L Peterson M.D. (Jacksonville FL)         
United States, New York
University of Rochester James P. Wilmot Cancer Institute Recruiting
Rochester, New York, United States, 14642
Contact: Jessica Mackowiak (Ellis)    585-275-2224   
Principal Investigator: Louis Constine, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office    919-668-3726      
Principal Investigator: Christopher Kelsey, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Charles J Masino    713-745-0194   
Contact: Irina Yi Chen   
Principal Investigator: Chelsea C Pinnix, MD PhD         
University Hospital Motol Recruiting
Prague, Czechia
Contact: Monika Stepanova   
Principal Investigator: Katerina Dedeckova, M.D.         
University of Torino Recruiting
Torino, Italy
Contact: Gabriella Furfaro         
Principal Investigator: Ricardo Umberto, M.D.         
Juntendo University Recruiting
Tokyo, Japan
Contact: Keisuke Sasai, M.D. Ph.D.    81-3-3813-3111   
Principal Investigator: Keisuke Sasai, M.D. Ph.D.         
Korea, Republic of
Yonsei University Health System Recruiting
Seoul, Korea, Republic of
Contact: Hong In Yoon, .M.D. Ph.D.    (+82-2)2228-8095   
Principal Investigator: Hong In Yoon, M.D. Ph.D         
National Cancer Center of Singapore Recruiting
Singapore, Singapore
Contact: Yeoh Kheng Wei, M.D.    +65-6436 8000   
Principal Investigator: Yeoh Kheng Wei, M.D.         
Sponsors and Collaborators
Duke University
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Principal Investigator: Christopher Kelsey, MD Duke University Health System
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Responsible Party: Duke University Identifier: NCT03681535    
Other Study ID Numbers: Pro00100510
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Reduce radiation dose
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin