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The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Risk | Experimental | Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy |
|
| Intermediate Risk | Experimental | Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy |
|
| High Risk | Experimental | High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin | Drug | Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) | Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy | 1 year |
| To determine the response rate | disease evaluations will be performed after the 2nd, 4th and 6th cycles. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Hochberg, MD | New York Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35584865 | Background | Hochberg J, Basso J, Shi Q, Klejmont L, Flower A, Bortfeld K, Harrison L, van de Ven C, Moorthy C, Islam H, Gerard P, Voss S, Cairo MS. Risk-adapted chemoimmunotherapy using brentuximab vedotin and rituximab in children, adolescents, and young adults with newly diagnosed Hodgkin's lymphoma: a phase II, non-randomized controlled trial. J Immunother Cancer. 2022 May;10(5):e004445. doi: 10.1136/jitc-2021-004445. |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D014750 | Vincristine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
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| Doxorubicin | Drug | Days: 1 and 15 Dose: 25 mg/m2/dose. |
|
|
| Vincristine | Drug | Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose). |
|
|
| Rituximab | Drug | Days: 2 and 16 Dose: 375 mg/m2/dose. |
|
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D058846 | Antibodies, Monoclonal, Murine-Derived |