Trial Search Results

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.

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborator: Teva Pharmaceuticals USA

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

Phase:

Phase 2

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
Recruiting