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A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy and 30 Gray Involved-Site Radiotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma


N/A
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin Lymphoma

Thank you

Trial Information

A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy and 30 Gray Involved-Site Radiotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma


Inclusion Criteria:



- Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma

- FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT

- Ann Arbor Stage I or II disease

- At least one of the following unfavorable risk factors as defined by GHSG: bulky
mediastinal mass (≥one-third maximum transverse thoracic diameter on
Posterior-Anterior/Lateral Chest X-ray or ≥10cm by CT imaging in axial plane), ESR ≥
50mm/h or ESR ≥30 mm/h in patients with "B" symptoms, extranodal involvement, or 3 or
more involved lymph node sites.

- Females of childbearing age must be on an acceptable form of birth control

- Age between 18 and 60

Exclusion Criteria:

- Cardiac ejection fraction ≤ 50%

- Hemoglobin-adjusted diffusing capacity for carbon monoxide < 60%

- ANC≤1000/μl and Platelets≤75,000/μl

- Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease

- Known pregnancy or breast-feeding

- Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending
physician and/or principal investigator, makes participation in this study
inappropriate.

- Peripheral neuropathy > grade 1

- Patients receiving treatment with systemic steroids

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

development of significant pulmonary toxicity

Outcome Description:

specifically non-infectious pneumonitis The definition of unacceptable pulmonary toxicity will be defined as the development of grade 2 or higher pneumonitis as defined by Common Terminology Criteria for Adverse Events (CTCAE version 4).

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Craig Moskowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

13-034

NCT ID:

NCT01868451

Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Hodgkin Lymphoma
  • DACARBAZINE
  • DOXORUBICIN/ADRIAMYCIN
  • SGN-35 (BRENTUXIMAB VEDOTIN)
  • VINBLASTINE
  • Involved-site radiation therapy (ISRT)
  • Early stage
  • 13-034
  • Hodgkin Disease
  • Lymphoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York