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Non-hodgkin LymphomaPhase 2RADICALNCT05253495

Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma

A Phase 2 study testing DOC Group B, Pv-COMRAD 1 and 2 Group B and Pv-R-CYM 1 and 2 Group B in people with Non-hodgkin Lymphoma and Hodgkin Lymphoma, run by New York Medical College at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 39 years
Conditions the study is for
Non-hodgkin Lymphoma, Hodgkin Lymphoma
What is being tested?
DOC Group B, Pv-COMRAD 1 and 2 Group B and Pv-R-CYM 1 and 2 Group B
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesUnited States
Study dates
1 Feb 2022to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mitchell Cairo, MD contact

9145942150

mitchell_cairo@nymc.edu

Lauren Harrison, RN contact

617-285-7844

lauren_harrison@nymc.edu

United States3 sites, 3 recruiting

  • University of Alabama

    Birmingham, Alabama, 35233

    Ana Xavier, MD, axavier@peds.uab.edu

    Not yet recruiting

  • University of Flordia

    Gainsville, Florida, 32610

    William Slayton, MD, slaytwb@peds.ufl.edu

    Recruiting

  • New York Medical College

    Vallhala, New York, 10595

    Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu

    Mitchell S. Cairo, MD

    Recruiting

Other trials in United States

About this study

Official 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

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).

Read the detailed 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.

Being tested
DOC Group B, Pv-COMRAD 1 and 2 Group B, Pv-R-CYM 1 and 2 Group B, DOC Group C, MAD CPR 1 and 2
Medical subject headings
Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DOC Group BDrug

    Also called Reduction Phase

    Cyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1

  • Pv-COMRAD 1 and 2 Group BDrug

    Also called Induction 1 and 2

    polatuzumab vedotin x1; dexamethasone x 5; vincristine x1, cyclophosphamide x 3; doxorubicin x1; methotrexate x; rituximab 2x; ITT x1

  • Pv-R-CYM 1 and 2 Group BDrug

    Also called Consolidation 1 and 2

    polatuzumab vedotin x 1; methotrexate x 1; rituximab x 1; cytarabine x 5;

  • DOC Group CDrug

    Also called Reduction with IT

    cyclophosphamide x 1, dexamethasone x 5; vincristine x1; IT triples x 3

  • MAD CPR 1 and 2Drug

    Also called Induction 1 and 2 Group C

    methotrexate x 1; dexamethasone x 5; polatuzumab Vedotin x 1, cyclophosphamide x 3; doxorubicin x 1; rituximab x2; IT triples x 2 in induction 1, IT triples x 2 in induction 2

  • Pv-R CYVE 1 and 2Drug

    Also called Consolidation 1 and 2 Group C CNS Negative

    Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4;

  • Pv-R CYVE-MTX 1 and 2Drug

    Also called Consolidation 1 and 2 Group C CNS Positive

    Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4; high dose cytarabine x4; high dose methotrexate x 1 (only consolidation 1); IT triples x 2 (only 1 in consolidation 2)

  • MAD CPDrug

    Also called Maintenance 1 Group C

    dexamethasone x1; polatuzumab vedotin x 1; cyclophosphamide x 2; doxorubicin x 1; high dose methotrexate x 1; IT triples x 1

  • Pv-Cytarabine/etoposideDrug

    Also called Maintenance 2, 4 Group C

    polatuzumab vedotin x 1; cytarabine x 5; etoposide x 3;

  • AD CPDrug

    Also called Maintenance 3 Group C

    polatuzumab vedotin x 1; cyclophosphamide x2; doxorubicin x 2;

  • Bv-AVD-R 1 and 2: COHORT IIaDrug

    Also called Intermediate Risk cohort IIa

    brentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2

  • Bv-NVD-R, Cycle 1-2Drug

    Also called Cohort IIa Rapid Early Responders

    brentuximab vedotin x 2; nivolumab x 2; vinblastine x2; dacarbazine x 2; rituximab x 2;

  • Bv-NVD-R, Cycle 1-4 SERDrug

    Also called Cohort IIa Slow Early Responders

    brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; rituximab x 2;

  • Bv-AVD-RDrug

    Also called High-Risk cohort IIb

    Brentuximab vedotin x2; doxorubicin x2; vinblastine x 2; dacarbazine x 2; rituximab x2;

  • Bv-NVD-R, Cycle 1-4 RERDrug

    Also called cohort IIb Rapid Early Responders

    brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;

  • Bv-NAVD-R, Cycle 1-2Drug

    Also called cohort IIb Slow Early Responders

    brentuximab vedotin x 2; nivolumab x 2; doxorubicin x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;

  • Involved Site Radiation TherapyRadiation

    Also called Cohort II ONLY

    21 Gy in 14 fractions of 1.50 Gy per day. The treatment will be given 5 days per week. All fields shall be treated once each day. The total elapsed treatment time will be 2.8 weeks (14 sessions) for each field.

Study groups in NCT05253495
Study groupRoleWhat they receive
Cohort 1aExperimentalMature 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).
Receives: Drug: DOC Group B; Drug: Pv-COMRAD 1 and 2 Group B; Drug: Pv-R-CYM 1 and 2 Group B
Cohort 1bExperimentalMB 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.
Receives: Drug: DOC Group C; Drug: MAD CPR 1 and 2; Drug: Pv-R CYVE 1 and 2; Drug: Pv-R CYVE-MTX 1 and 2; Drug: MAD CP; Drug: Pv-Cytarabine/etoposide; Drug: AD CP; Radiation: Involved Site Radiation Therapy
Cohort 2aExperimentalClassical 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.
Receives: Drug: Bv-AVD-R 1 and 2: COHORT IIa; Drug: Bv-NVD-R, Cycle 1-2; Drug: Bv-NVD-R, Cycle 1-4 SER
Cohort 2bExperimentalCOHORT 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.
Receives: Drug: Bv-AVD-R; Drug: Bv-NVD-R, Cycle 1-4 RER; Drug: Bv-NAVD-R, Cycle 1-2; Radiation: Involved Site Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade 3 and 4 Adverse Events related to polatuzumab vedotin

    to evaluate the DLTs of polatuzumab vedotin (Pv) in combination with rituximab (RTX) containing French-American-British (FAB) chemoimmunotherapy, with reduced dose anthracycline to MB-NHL

    Measured: 1 year

  2. Grade 3 and 4 Adverse events related to nivolumab

    To evaluate the DLTs of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin (Bv), vinblastine, dacarbazine and rituximab, with reduced dose anthracycline in intermediate and high risk cHL

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start1 Feb 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253495
Sponsor's protocol ID
14601
Acronym
RADICAL
Status last verified
Jun 2025
First submitted
14 Feb 2022
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DOC Group B, Pv-COMRAD 1 and 2 Group B and Pv-R-CYM 1 and 2 Group B in people with Non-hodgkin Lymphoma and Hodgkin Lymphoma, run by New York Medical College at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mitchell Cairo, MD (9145942150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade 3 and 4 Adverse Events related to polatuzumab vedotin (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05253495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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