Valhalla, New York 10595


Purpose:

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).


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.


Study is Available At:


Original ID:

NYMC-568


NCT ID:

NCT02398240


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

1 Year


Maximum Age:

29 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York Medical College


Oversight Authority:

United States: Data and Safety Monitoring Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jessica Hochberg, MD
Principal Investigator
New York Medical College
Primary Contact:Jessica Hochberg, MD
9145942132
jessica_hochberg@nymc.edu
Backup Contact:Mitchell Cairo, MD
9145942150
mitchell_cairo@nymc.edu

Study Dates

Start Date:May 2015
Completion Date:June 2020
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:March 2019
Last Changed Date:March 11, 2019
First Received Date:March 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
Time Frame:1 year
Safety Issues:False
Description:Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
Outcome Type:Primary Outcome
Measure:To determine the response rate
Time Frame:1 year
Safety Issues:False
Description:disease evaluations will be performed after the 2nd, 4th and 6th cycles.

Study Interventions

Intervention Type:Drug
Name:Brentuximab Vedotin
Description:Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
Arm Name:Low Risk
Other Name:Adcetris
Intervention Type:Drug
Name:Doxorubicin
Description:Days: 1 and 15 Dose: 25 mg/m2/dose.
Arm Name:Low Risk
Other Name:Doxil, Adriamycin
Intervention Type:Drug
Name:Vincristine
Description:Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
Arm Name:Low Risk
Other Name:Oncovin
Intervention Type:Drug
Name:Rituximab
Description:Days: 2 and 16 Dose: 375 mg/m2/dose.
Arm Name:Intermediate Risk
Other Name:Rituxan

Study Arms

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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mitchell Cairo

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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