Brentuximab for Newly Diagnosed Hodgkin Disease

Hodgkin Lymphoma Clinical Trial

Official title:

A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398240
• Other study ID #: NYMC-568
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: December 2022

Study information

• Verified date: October 2023
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Brentuximab Vedotin
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
• Doxorubicin
Days: 1 and 15 Dose: 25 mg/m2/dose.
• Vincristine
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
• Rituximab
Days: 2 and 16 Dose: 375 mg/m2/dose.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mitchell Cairo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To determine the response rate	disease evaluations will be performed after the 2nd, 4th and 6th cycles.	1 year