Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Conditions

• Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• brentuximab vedotin — DRUG
  1.2 mg/kg by IV infusion
• doxorubicin — DRUG
  25 mg/m\^2 by IV infusion
• vinblastine — DRUG
  6 mg/m\^2 by IV infusion
• dacarbazine — DRUG
  375 mg/m\^2 by IV infusion
• G-CSF — DRUG
  Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
• nivolumab — DRUG
  240 mg by IV infusion

Study Details

This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C). The drugs used in Part A are a combination of targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are called "A+AVD." Participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses). Part A will look at whether the A+AVD drug combination reduces the number of participants who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening. Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called "AN+AD." Parts B and C will study how well the drugs work to treat cHL and what side effects they cause.

Key Dates

Start date

Jan 28, 2019

Status verified

Aug 2025

Primary completion

Nov 7, 2022

Completion

Aug 23, 2024

Study Design

Enrollment

255 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: A+AVD
  Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.
• Experimental: Part B: AN+AD
  Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.
• Experimental: Part C: AN+AD
  Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.

Primary Outcome Measure

Febrile Neutropenia (FN) Rate (Part A) [ Time Frame: 7.5 months ]

Locations (55)

Find similar trials in Fountain Valley, CA

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