NCT05253495 Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma
| NCT ID | NCT05253495 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New York Medical College |
| Condition | Non-hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2022-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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)
Contact & Investigator
Mitchell Cairo, MD
PRINCIPAL INVESTIGATOR
New York Medical Center
Frequently Asked Questions
Who can join the NCT05253495 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 39 Years, studying Non-hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05253495 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05253495 currently recruiting?
Yes, NCT05253495 is actively recruiting participants. Contact the research team at mitchell_cairo@nymc.edu for enrollment information.
Where is the NCT05253495 trial being conducted?
This trial is being conducted at Birmingham, United States, Gainsville, United States, Vallhala, United States.
Who is sponsoring the NCT05253495 clinical trial?
NCT05253495 is sponsored by New York Medical College. The principal investigator is Mitchell Cairo, MD at New York Medical Center. The trial plans to enroll 80 participants.