Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-39
SponsorNew York Medical College
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adequate organ function
Disqualifiers
Primary mediastinal B-cell lymphoma (PMBL)
T-cell/histiocyte-rich large B-cell lymphoma
Gray zone lymphoma
Follicular lymphoma
Trial design
Design model
Parallel
Treatments tested in this trial
DOC Group B
DrugCyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1
Pv-COMRAD 1 and 2 Group B
Drugpolatuzumab 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 B
Drugpolatuzumab vedotin x 1; methotrexate x 1; rituximab x 1; cytarabine x 5;
DOC Group C
Drugcyclophosphamide x 1, dexamethasone x 5; vincristine x1; IT triples x 3
MAD CPR 1 and 2
Drugmethotrexate 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 2
DrugPolatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4;
Pv-R CYVE-MTX 1 and 2
DrugPolatuzumab 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 CP
Drugdexamethasone x1; polatuzumab vedotin x 1; cyclophosphamide x 2; doxorubicin x 1; high dose methotrexate x 1; IT triples x 1
Pv-Cytarabine/etoposide
Drugpolatuzumab vedotin x 1; cytarabine x 5; etoposide x 3;
AD CP
Drugpolatuzumab vedotin x 1; cyclophosphamide x2; doxorubicin x 2;
Bv-AVD-R 1 and 2: COHORT IIa
Drugbrentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2
Bv-NVD-R, Cycle 1-2
Drugbrentuximab vedotin x 2; nivolumab x 2; vinblastine x2; dacarbazine x 2; rituximab x 2;
Bv-NVD-R, Cycle 1-4 SER
Drugbrentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; rituximab x 2;
Bv-AVD-R
DrugBrentuximab vedotin x2; doxorubicin x2; vinblastine x 2; dacarbazine x 2; rituximab x2;
Bv-NVD-R, Cycle 1-4 RER
Drugbrentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;
Bv-NAVD-R, Cycle 1-2
Drugbrentuximab vedotin x 2; nivolumab x 2; doxorubicin x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;
Involved Site Radiation Therapy
Radiation21 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Cohort 1aExperimental treatment 3 interventions
Group B: Cohort 1bExperimental treatment 8 interventions
Group C: Cohort 2aExperimental treatment 3 interventions
Group D: Cohort 2bExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
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
Time frame
1 year2
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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov