This trial will investigate the effects of different combinations of anti-cancer drugs in patients with pediatric Hodgkin lymphoma (HL). The main outcomes measured will be how fast a patient responds to therapy and also survival in general, and without cancer returning or getting worse. The trial is recruiting in Memphis, Tennessee, United States.
The details
Pediatric HL involves patients aged between 0-21. There are many anti-cancer therapies used to treat pediatric HL. Which therapy to use is often determined by the risk level of the HL. Low-risk HL is an early stage without bulky tumors. Intermediate-risk HL is early stage HL with bulky tumors or with symptoms such as fever, night sweats, and weight loss or late-stage HL without bulky tumors or these symptoms. High-risk HL is late stage HL with bulky tumors and symptoms such as fever, night sweats and weight loss. It is important to investigate the effects of different anti-cancer drugs in different risk groups of pediatric HL.
This trial will determine how well patients respond to treatment adapted to their type of disease.
Who are they looking for?
200 patients are needed for this study. To participate, individuals must have been diagnosed with low or intermediate risk HL before the age of 21 or with high-risk HL before the age of 18. Patients must have adequate kidney, liver and blood cell count tests, as well as normal heart and lung functions.
Individuals with high-risk HL cannot participate in this trial if they have experienced severe nerve pain or other neurologic condition.
How will it work
Patients with low-risk HL will receive 2 rounds of BEABOVP chemotherapy. This is a combination of bendamustine (Levact), etoposide (VePesid), doxorubicin (Adriamycin), bleomycin (Blenoxane), vincristine (Oncovin), vinblastine (Velban) and prednisone (Deltasone). Patients may then receive radiation therapy in any lymph nodes which have not responded.
Patients with intermediate-risk HL will receive 3 rounds of BEABOVP chemotherapy. If patients have responded after 2 rounds of treatment, prednisone may be removed from the treatment. Patients may then receive radiation therapy in any lymph nodes which have not responded.
Patients with high-risk HL will receive 2 rounds of AEPA chemotherapy. This is a combination of brentuximab vedotin (Adcedris), etoposide, prednisone, and doxorubicin. They will also receive 4 cycles of CAPDac chemotherapy. This includes cyclophosphamide (Cytoxan), brentuximab vedotin, prednisone and DTIC (Dacarbazine). If patients have responded after 2 rounds of treatment, prednisone may be removed from the treatment. Patients may then receive radiation therapy in any lymph nodes which have not responded.
Response to treatment, quality of life, side effects and survival, disease worsening and cancer returning will be measured up to 3 years.
