New treatment approach for pediatric Hodgkin lymphoma

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

This study is testing a new treatment plan for children and young adults with Hodgkin lymphoma to see if personalized chemotherapy can improve their chances of staying cancer-free while managing side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: N/A to 25 Years
• Sex: All
• Sponsor: St. Jude Children's Research Hospital (Academic / other)
• Drugs / interventions: brentuximab, Chemotherapy, cyclophosphamide, doxorubicin, prednisone
• Locations: 8 sites (Palo Alto, California and 7 other locations)
• Trial ID: NCT03755804 on ClinicalTrials.gov

What this trial studies

This phase II study focuses on using risk and response-adapted therapy for children and young adults with classical Hodgkin lymphoma. Patients are categorized into low, intermediate, and high-risk groups, with tailored chemotherapy regimens including bendamustine, etoposide, and brentuximab vedotin. The study aims to evaluate treatment efficacy and event-free survival, while also assessing the toxicities associated with the therapies. Residual node radiotherapy will be administered based on response after two cycles of chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 21 years or younger with newly diagnosed classical Hodgkin lymphoma.

Not a fit: Patients with relapsed Hodgkin lymphoma or those older than the age limits specified may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for pediatric patients with Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar risk-adapted approaches in treating Hodgkin lymphoma, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Palo Alto, California and 7 other locations

• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States (Recruiting)
• St. Jude Midwest Affiliate - Peoria — Peoria, Illinois, United States (Recruiting)
• St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center) — Baton Rouge, Louisiana, United States (Recruiting)
• Maine Children's Cancer Program — Scarborough, Maine, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
• St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital — Charlotte, North Carolina, United States (Recruiting)
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Ehrhardt, MD, MS — St. Jude Children's Research Hospital
• Study coordinator: Matthew Ehrhardt, MD, MS

Conditions Hodgkin Lymphoma; Pediatric Cancer; Frontline Therapy; Response Adapted Therapy; Risk Adapted Therapy