Back to resultsBrentuximab for Newly Diagnosed Hodgkin Disease
Primary Purpose
Hodgkin Lymphoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brentuximab Vedotin
Doxorubicin
Vincristine
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma
Eligibility Criteria
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.
Sites / Locations
- New York Medical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low Risk
Intermediate Risk
High Risk
Arm Description
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
Outcomes
Primary Outcome Measures
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
To determine the response rate
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02398240
Brief Title
Brentuximab for Newly Diagnosed Hodgkin Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2015 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mitchell Cairo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Risk
Arm Type
Experimental
Arm Description
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
Arm Title
Intermediate Risk
Arm Type
Experimental
Arm Description
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Arm Title
High Risk
Arm Type
Experimental
Arm Description
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Other Intervention Name(s)
Adcetris
Intervention Description
Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Doxil, Adriamycin
Intervention Description
Days: 1 and 15 Dose: 25 mg/m2/dose.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Days: 2 and 16 Dose: 375 mg/m2/dose.
Primary Outcome Measure Information:
Title
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
Description
Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
Time Frame
1 year
Title
To determine the response rate
Description
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Hochberg, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35584865
Citation
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.
Results Reference
derived
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Brentuximab for Newly Diagnosed Hodgkin Disease
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