Brentuximab for Newly Diagnosed Hodgkin Disease

NCT02398240 | Completed Phase 2

• 1 other identifier: NYMC-568
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Low Risk

EXPERIMENTAL

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

Drug: Brentuximab Vedotin; Drug: Doxorubicin; Drug: Vincristine

Intermediate Risk

EXPERIMENTAL

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

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

High Risk

EXPERIMENTAL

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

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

Interventions

Brentuximab Vedotin DRUG

Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)

Also known as: Adcetris

High Risk; Intermediate Risk; Low Risk

Doxorubicin DRUG

Days: 1 and 15 Dose: 25 mg/m2/dose.

Also known as: Doxil, Adriamycin

High Risk; Intermediate Risk; Low Risk

Vincristine DRUG

Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).

Also known as: Oncovin

High Risk; Intermediate Risk; Low Risk

Rituximab DRUG

Days: 2 and 16 Dose: 375 mg/m2/dose.

Also known as: Rituxan

High Risk; Intermediate Risk

Eligibility Criteria

• Age: 1 Year - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mitchell Cairo: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

Related 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.

  PMID: 35584865 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin; Doxorubicin; liposomal doxorubicin; Vincristine; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Murine-Derived

Study Officials

• Jessica Hochberg, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Vice Chair

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 25, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)