Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Trial ID or NCT#

NCT03755804

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Eligibility Criteria

Ages Eligible for Study: Younger than 25 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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.
  2. * 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
  3. * 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:
  1. * 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.

Investigator(s)

Michael Link

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Contact

Shivani Reddy
650-498-5189