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Immunotherapy
Chemoradiotherapy + Immunotherapy for Pediatric Lymphoma (RADICAL Trial)
Phase 2
Recruiting
Led By Mitchell Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
COHORT Ia: stage III with LDH ≥ 2 ULN OR stage IV (5-24% bone marrow lymphoma infiltration)
COHORT I: Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, Diffuse large B-cell lymphoma, NOS, High grade B-cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
RADICAL Trial Summary
This trial suggests that adding immunotherapy to existing cancer treatments is safe and effective, especially in reducing exposure to harmful anthracyclines.
Who is the study for?
This trial is for children, adolescents, and young adults with specific types of lymphoma (MB-NHL or cHL). Participants must have newly diagnosed disease according to WHO Classification, adequate organ function, and fall into certain risk categories based on the stage of their disease. Those with other forms of lymphoma like follicular or T-cell/histiocyte-rich large B-cell are not eligible.Check my eligibility
What is being tested?
The study tests if adding targeted immunotherapy to standard chemoradiotherapy can reduce anthracycline use while maintaining control over lymphoma in young patients. It involves various treatment groups receiving different combinations of chemotherapy drugs and immunotherapies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to therapy, such as inflammation in organs; general symptoms like fatigue; complications from chemotherapy including digestive issues and blood disorders; plus increased infection risk.
RADICAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in stage III with high LDH levels or in stage IV with 5-24% bone marrow lymphoma infiltration.
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I have been diagnosed with a specific type of lymphoma.
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I have been newly diagnosed with a specific type of lymphoma.
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My cancer is in an early to mid-stage, possibly with some lymph node involvement.
RADICAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade 3 and 4 Adverse Events related to polatuzumab vedotin
Grade 3 and 4 Adverse events related to nivolumab
RADICAL Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 2bExperimental Treatment4 Interventions
COHORT IIb (Classical Hodgkin lymphoma, HIGH RISK) Cohort IIb patients will receive 2 cycles of brentuximab vedotin (Bv), doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-AVD-R 1 and 2). Response assessment will be performed with FDG-PET scan after 2 cycles of Bv-AVD-R. Rapid early responders (RER) will continue therapy with 4 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1, 2, 3, and 4). RERs will not receive radiation therapy. Patients deemed to be Slow Early Responders (SER) after 2 cycles of Bv-AVD-R will receive 2 cycles of Bv, nivolumab, doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-NAVD-R 1 and 2), followed by 4 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1, 2, 3, and 4). Radiation therapy will be given at completion of therapy only for SER patients NOT achieving complete remission at the end of chemoimmunotherapy.
Group II: Cohort 2aExperimental Treatment3 Interventions
Classical Hodgkin lymphoma, INTERMEDIATE RISK will receive 2 cycles of brentuximab vedotin (Bv), doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-AVD-R 1 and 2). Response assessment with FDG-PET scan after 2 cycles of Bv-AVD-R. Rapid early responders (RER) will continue therapy with 2 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1 and 2). RERs will not receive radiation therapy. Patients deemed to be Slow Early Responders (SER) after 2 cycles of Bv-AVD-R will continue therapy with 4 cycles of Bv-NVD-R (Bv-NVD-R 1, 2, 3, and 4). Radiation therapy will be given at completion of therapy only for SER patients NOT achieving complete remission at the end of chemoimmunotherapy.
Group III: Cohort 1bExperimental Treatment8 Interventions
MB NHL, GROUP C will receive reduction therapy with DOC. Patients with < 20% tumor reduction will be off protocol. Patients with ≥ 20% tumor reduction get Induction 1 and 2 with cyclophosphamide, doxorubicin, dexamethasone, high dose methotrexate, polatuzumab vedotin, and triple intrathecal chemotherapy (M8A30D CPR) 1 and 2, then Consolidation 1 with Pv-R-CYVE 1. If no residual disease, they get Consolidation 2 (Pv-R-CYVE 2), followed by Maintenance (M) 1 with M8A30D CP, M 2 with Pv-cytarabine/etoposide, M 3 with cyclophosphamide, doxorubicin, dexamethasone and polatuzumab vedotin (A30D CP), and M 4 with Pv-cytarabine/etoposide. Cohort Ib patients with CNS disease will receive additional intrathecal chemotherapy and high dose methotrexate during Consolidation.
Group IV: Cohort 1aExperimental Treatment3 Interventions
Mature B-cell Non-hodgkin Lymphoma [MB NHL], GROUP B will receive reduction therapy with dexamethasone, vincristine and cyclophosphamide (DOC), then undergo disease assessment. If tumor reduction ≥ 20%, will get induction 1 and 2 with polatuzumab vedotin, cyclophosphamide, vincristine, methotrexate, rituximab, doxorubicin (Pv-COM3RA25D) 1 and 2, then Consolidation 1 with rituximab, cytarabine, methotrexate (R-CYM) . Patients will undergo disease assessment post Consolidation 1. If no residual disease, they proceed to receive Consolidation 2 with Pv-R-CYM (R-CYM 2).
Cohort Ia patients with < 20% tumor reduction post DOC will be assigned to Cohort Ib starting at Induction 1. Cohort Ia patients with residual disease post Consolidation 1 will be assigned to Cohort Ib starting at Consolidation 1 polatuzumab vedotin, rituximab, high dose cytarabine, cytarabine, high dose methotrexate, etoposide (Pv-R-CYVE 1).
Find a Location
Who is running the clinical trial?
New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
5,981 Total Patients Enrolled
Mitchell Cairo, MDPrincipal InvestigatorNew York Medical Center
13 Previous Clinical Trials
256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I am in stage III with high LDH levels or in stage IV with 5-24% bone marrow lymphoma infiltration.I have been diagnosed with a specific type of lymphoma.I have been newly diagnosed with a specific type of lymphoma.I have been diagnosed with a type of lymphoma called nodular lymphocyte-predominant Hodgkin.I have been diagnosed with follicular lymphoma.I have Classical Hodgkin lymphoma.I have been diagnosed with T-cell/histiocyte-rich large B-cell lymphoma.My cancer is at a late stage, ranging from IIB to IV.My cancer involves the brain or bone marrow, or my tumor didn't shrink much after specific chemotherapy.My cancer is in an early to mid-stage, possibly with some lymph node involvement.I have lymphoma after receiving an organ transplant.My condition is primary mediastinal B-cell lymphoma.My condition is gray zone lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1a
- Group 2: Cohort 1b
- Group 3: Cohort 2a
- Group 4: Cohort 2b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to enroll in this scientific research?
"To meet the criteria for this trial, applicants must possess lymphoma and be between 3 to 39 years of age. Currently, 80 candidates are being sought out."
Answered by AI
Does the use of AD CP carry any inherent risks for those who partake?
"The safety of AD CP has been evaluated as a 2 due to the fact that there is supportive evidence for its safety, but not yet any demonstration of it being efficacious."
Answered by AI
How many individuals are being enrolled in this investigation?
"Affirmative. Clinicaltrials.gov provides evidence that this research initiative, which was initially posted on February 1st 2022, is actively seeking volunteers. 80 subjects are being sought from a single site of enrollment."
Answered by AI
Is this experiment actively enrolling participants?
"Affirmative. Clinicaltrials.gov states that this clinical trial is actively searching for prospective candidates after being initially published on February 1st 2022 and most recently edited on June 9th 2022. The research hopes to onboard 80 participants from a single site."
Answered by AI
Does the age requirement for this trial extend beyond 50 years old?
"As per the eligibility requirements of this clinical trial, minors as young as 3 and adults no older than 39 may participate."
Answered by AI
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