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Results summary of St. Jude clinical trial: 

HLHR13

 
 

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma (HLHR13)

Why was this study done?

Brentuximab vedotin (Bv) is a drug that targets Hodgkin lymphoma. In other studies, this drug was effective in patients whose Hodgkin lymphoma returned after treatment. We thought it might also work well against high-risk disease. In this study, we used Bv instead of vincristine. Vincristine is a similar drug but is not targeted for Hodgkin lymphoma. By using Bv, we hope to have better results while reducing treatment side effects.

The study’s main goals were to:

  • Find out how many patients’ cancer would go into remission (no signs of symptoms of Hodgkin lymphoma) and avoid radiation therapy after two cycles of chemotherapy (chemo) that combine Bv with other drugs
  • Find out how many patients would go into long-term remission after being treated on this study

When was this study done?

The study opened in August 2013 and closed in July 2018.

What did the study consist of?

All patients got two cycles of chemo with Bv, etoposide, prednisone and doxorubicin. Then tests and imaging scans were done to see if any cancer remained. After that, all patients got four more cycles of chemo with cyclophosphamide, Bv, prednisone and dacarbazine.

Patients whose tests and scans were clear of cancer after the first two cycles did not get radiation therapy. Those with signs of Hodgkin lymphoma got radiation treatment to any remaining sites of lymphoma after all six cycles of chemo.

What did we learn from this study?

Overall three-year survival for the trial was 99%. Of the 77 patients in the study, 35% were spared radiation. When radiation was needed, it was precisely tailored, and doses were reduced when possible. By removing vincristine from the treatment, patients also reported a reduction in nerve problems. In our new clinical trial, even fewer patients are expected to receive radiation therapy because of how we now define remission after two cycles.

What are the next research steps as a result of this study?

Bv is being used in other national trials for the care of children with Hodgkin lymphoma. Longer follow-up will show whether this approach also reduces the risk of cancers later in life, since the treatment minimizes radiation exposure.

In our current trial at St. Jude, we are removing prednisone from the chemo cycles for patients whose cancer is gone after two cycles. Prednisone causes such side effects as:

  • mood swings
  • increased hunger
  • acne
  • higher blood pressure and blood sugar
  • weak bones, with possible death of bone tissue

Avoiding prednisone in the last four cycles could improve quality of life and prevent some acute and long-term side effects while maintaining the same chance of cure.

How does this study affect my child?

Every childhood cancer survivor should receive long-term follow-up care. Through the St. Jude After Completion of Care clinic, your child will receive information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines that apply to your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publication generated from this study:

Excellent Outcome for Pediatric Patients with High-Risk Hodgkin Lymphoma Treated with Brentuximab Vedotin and Risk-Adapted Residual Node Radiation. Metzger ML, Link MP, Billett AL, Flerlage J, Lucas JT Jr, Mandrell BN, Ehrhardt MJ, Bhakta N, Yock TI, Friedmann AM, de Alarcon P, Luna-Fineman S, Larsen E, Kaste SC, Shulkin B, Lu Z, Li C, Hiniker SM, Donaldson SS, Hudson MM, Krasin MJ. J Clin Oncol. 2021 Apr 7:JCO2003286. https://pubmed.ncbi.nlm.nih.gov/33826362/