Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: bendamustine
- drug: Etoposide
- drug: Doxorubicin
- drug: Bleomycin
- drug: Vincristine
- drug: Vinblastine
- drug: Prednisone
- drug: Filgrastim
- drug: Brentuximab Vedotin
- drug: Cyclophosphamide
- drug: DTIC
- other: Quality of Life Measurements
- radiation: Radiotherapy
Eligibility
Inclusion Criteria:
- Histologically confirmed, previously untreated CD30+ classical HL. (Participants are
still eligible if they received limited emergent RT or steroid therapy - maximum of 7
days if within the last month or as approved by PI).
- Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their
22nd birthday) for low-risk and intermediate-risk
- Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their
26th birthday) for high-risk
- All Ann Arbor stages.
- Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)
- Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy
(mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
and IB, IIIA.
- High-Risk: IIB, IIIB, IV
- Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted
for age and gender as follows: Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL
for males and 0.6 mg/dL for females, Age 2 to < 6 years: maximum serum creatinine 0.8
mg/dL for males and 0.8 mg/dL for females, Age 6 to < 10 years: maximum serum
creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to < 13 years: maximum
serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to < 16 years:
maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years:
maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females
- Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x
ULN for age).
- Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease
diagnosis
- Absolute neutrophil count (ANC) ≥1000/µL
- Platelets ≥ 75,000/µL
- Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or
MUGA, unless decreased function is due to large mediastinal mass or effusion related
to HL.
- Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise
intolerance, and a pulse oximetry > 92% on room air unless secondary to a large
mediastinal mass or effusion related to HL.
- Female participant who is post-menarchal must have a negative urine or serum pregnancy
test.
- Female or male participant of reproductive potential must agree to use an effective
contraceptive method throughout duration of study treatment.
Exclusion Criteria:
- CD30 negative HL.
- Has received prior therapy for Hodgkin lymphoma
- Inadequate organ function
- High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active
neurologic disease that would impede the ability to assess neurologic toxicities.
- Inability or unwillingness of research participant or legal guardian / representative
to give written informed consent.
Ages Eligible for Study
N/A - 25 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shivani Reddy
650-498-5189
I'm interested
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.
