Brentuximab for Newly Diagnosed Hodgkin Disease

Mitchell Cairo

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: Rituximab; Drug: Vincristine; Drug: Brentuximab Vedotin; Drug: Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02398240

NYMC-568

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
• Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN
• Shortening fraction >27% by echocardiogram, or
• Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
• For patients age 1-16 years, Lansky score of ≥60.
• For patients > 16 years, Karnofsky score of ≥60.
• No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome.

Exclusion criteria

• Females who are pregnant (positive HCG) or lactating.
• Karnofsky <60% or Lansky <60% if less than 16 years of age.
• Age ≤1 year or >29.99 years of age.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Low Risk

Experimental group

Description:

Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy

Treatment:

Drug: Doxorubicin

Drug: Brentuximab Vedotin

Drug: Vincristine

Intermediate Risk

Experimental group

Description:

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

Treatment:

Drug: Doxorubicin

Drug: Brentuximab Vedotin

Drug: Vincristine

Drug: Rituximab

High Risk

Experimental group

Description:

High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Treatment:

Drug: Doxorubicin

Drug: Brentuximab Vedotin

Drug: Vincristine

Drug: Rituximab