Brentuximab for Newly Diagnosed Hodgkin Disease

Part of paid clinical trials in Valhalla, New York.

Sponsor
Mitchell Cairo
Study ID
NCT02398240
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 29 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
May 31, 2015
Status verified
Oct 2023
Primary completion
Jun 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low Risk
    Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
  • Experimental: Intermediate Risk
    Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
  • Experimental: High Risk
    High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy

Primary Outcome Measure

To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York Medical CollegeValhallaNew York10595-

Find similar trials in Valhalla, NY

By research site
New York Medical College· Valhalla, NY

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