Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma (RADICAL)
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StatusAccepting Candidates
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Age3 Years - 39 Years
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SexesAll
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Healthy VolunteersNo
Objective
The addition of targeted immunotherapy will be safe and well tolerated and facilitate the reduction of anthracycline exposure while preserving lymphoma disease control in children, adolescents and young adults (CAYA) with mature B-cell non-Hodgkin lymphoma (MB-NHL) and classical Hodgkin lymphoma (cHL).
Description
The primary objective is 1) to determine feasibility and safety, as defined by dose limiting toxicities (DLTs), of adding polatuzumab vedotin (Pv) in combination with rituximab (RTX) containing French-American-British (FAB) chemoimmunotherapy, with reduced dose anthracycline, in CAYA with intermediate and high risk newly diagnosed MB-NHL; 2) To define the feasibility and safety, as defined by DLTs, of the addition of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin (Bv), vinblastine, dacarbazine and rituximab, with reduced dose anthracycline, in CAYA with newly diagnosed intermediate and high risk cHL.
Details
Full study title | Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure from Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults with Lymphoma (RADICAL) |
Protocol number | OCR43232 |
ClinicalTrials.gov ID | NCT05253495 |
Phase | Phase 2 |
Eligibility
Inclusion Criteria:
- Newly diagnosed patients with histologically or cytologically proven newly diagnosed MB-NHL or cHL according to WHO Classification who meet the following criteria are
Eligible:
Cohort I:
Burkitt lymphoma (ICD-O 9687/3) Burkitt-like lymphoma with 11q aberration (ICD-O 9687/3)
Diffuse large B-cell lymphoma, NOS (ICD-O 9680/3) High grade B-cell lymphoma (ICD-O
9680/3)
Cohort Ia: stage III with Ldh ≥ 2 Uln Or stage IV (5-24% bone marrow lymphoma
infiltration) (GROUP B)61
Cohort Ib: any Cns involvement and/or Bm involvement (≥ 25% lymphoma cells) (Group C)61
OR patients with less than 20% tumor size reduction post chemotherapy with
cyclophosphamide, dexamethasone, vincristine (DOC Reduction for Cohort Ia).
COHORT II Classical Hodgkin lymphoma (ICD-O 9650/3, 9663/3, 9651/3, 9652/3, 9653/3)
Cohort IIa: stage I-Iia with bulky ± E, I-Iib no bulky ± E, Iiia ± E (Intermediate Risk)
Cohort IIb: stage Iib with bulky ± E, Iiia with bulky ± E, Iiib, IV (High Risk)
- Adequate organ function
Exclusion Criteria:
Primary mediastinal B-cell lymphoma (PMBL)
T-cell/histiocyte-rich large B-cell lymphoma
Gray zone lymphoma
Follicular lymphoma
Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
Posttransplant lymphoproliferative lymphoma (PTLD)
Lead researcher
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William Slayton, MDPediatric Hematologist/Oncologist (Child Cancer Specialist)
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.