Brentuximab for Newly Diagnosed Hodgkin Disease

Phase 2

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab

• Registration Number: NCT02398240
• Lead Sponsor: Mitchell Cairo

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-15
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Study Start: 2015-05
• Primary Completion: 2022-06
• Study Completion: 2022-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Risk	Brentuximab Vedotin	Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Low Risk	Doxorubicin	Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Low Risk	Vincristine	Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Intermediate Risk	Brentuximab Vedotin	Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Intermediate Risk	Doxorubicin	Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Intermediate Risk	Vincristine	Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Intermediate Risk	Rituximab	Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
High Risk	Doxorubicin	High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
High Risk	Brentuximab Vedotin	High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
High Risk	Vincristine	High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
High Risk	Rituximab	High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Primary Outcome Measures

Name	Time	Method
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)	1 year	Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
To determine the response rate	1 year	disease evaluations will be performed after the 2nd, 4th and 6th cycles.

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States