Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2015-05-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Low Risk
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
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).
Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
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.
High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Karnofsky \<60% or Lansky \<60% if less than 16 years of age.
* Age ≤1 year or \>29.99 years of age.
1 Year
29 Years
ALL
No
Sponsors
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Mitchell Cairo
OTHER
Responsible Party
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Mitchell Cairo
Executive Vice Chair
Principal Investigators
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Jessica Hochberg, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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New York Medical College
Valhalla, New York, United States
Countries
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References
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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.
Other Identifiers
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NYMC-568
Identifier Type: -
Identifier Source: org_study_id
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