Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/2/2018 |
Start Date: | May 2013 |
End Date: | May 2019 |
Contact: | Anita Kumar, MD |
Phone: | 212-639-2668 |
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
The purpose of this study is to compare the outcomes across the 4 different treatment groups.
The investigators hope that this treatment will improve the ability to cure more patients
with HL and also limit the long-term side effects from the treatment. Although eliminating
radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it
is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the
Hodgkin lymphoma coming back after initial treatment.
The investigators hope that this treatment will improve the ability to cure more patients
with HL and also limit the long-term side effects from the treatment. Although eliminating
radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it
is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the
Hodgkin lymphoma coming back after initial treatment.
Inclusion Criteria:
- Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at
enrolling institution
- 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
- Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm
OR coronal maximal diameter > 7.0 cm on CT imaging
- Females of childbearing age must be on an acceptable form of birth control per
institutional standards
- Ages 18 and over
Exclusion Criteria:
- Cardiac ejection fraction ≤ 50%
- Hemoglobin-adjusted diffusing capacity for carbon monoxide < 40%
- ANC≤1000/μl and Platelets≤75,000/μl
- Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease
- Serum creatinine clearance of <30 mL/min as estimated by the Cockcroft-Gault Method
- Known pregnancy or breast-feeding
- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)
- Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending
physician and/or MSKCC principal investigator, makes participation in this study
inappropriate.
- Peripheral neuropathy > grade 1
- Patients receiving chronic treatment with systemic steroids. However, patients can
receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
We found this trial at
10
sites
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Carla Casulo, MD
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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500 Westchester Avenue
Harrison, New York 10604
Harrison, New York 10604
Phone: 212-639-2668
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Anita Kumar, MD
Phone: 212-639-2668
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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