Hodgkin Lymphoma
Conditions
Keywords
DACARBAZINE, DOXORUBICIN/ADRIAMYCIN, SGN-35 (BRENTUXIMAB VEDOTIN), VINBLASTINE, Involved-site radiation therapy (ISRT), Early stage, 13-034
Brief summary
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.
Interventions
DRUGDoxorubicin HCL
DRUGVinblastine Sulfate
DRUGDacarbazine
RADIATIONInvolved-Site Radiation Therapy (ISRT)
PROCEDUREInterim PET
RADIATIONconsolidation volume RT (CVRT)
Sponsors
Seagen Inc.
University of Rochester
City of Hope Medical Center
Stanford University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| development of significant pulmonary toxicity | 1 year | 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). |
| complete responses (all cohorts) | 1 year | Evaluate the rate of PET-negative complete responses after completion of the treatment program (8 weeks (+/- 2 weeks) after completion of radiotherapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the prognostic significance | 1 year | (i.e. correlation with progression free survival) of interim fluorodeoxyglucose-positron emission tomography (PET) in this patient population measured by visual analysis and semi-quantitative analysis. |
Countries
United States
Outcome results
None listed