Active — Not RecruitingPhase 2

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

United States77 participantsStarted 2013-08-12

Plain-language summary

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment). * Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday). * Ann Arbor stage IIB, IIIB, IVA, or IVB. * Adequate renal function based on GFR ≥ 70 ml/min/1.73m\^2 or serum creatinine adjusted for age and gender. * Adequate hepatic function (total bilirubin \< 1.5 x ULN for age, and SGOT/SGPT \< 2.5 x ULN for age). * 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, except as noted above. * Inadequate organ function as described above. * Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

What they're measuring

Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control

Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control

Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)

Complete Response Rate Estimate for All Evaluable Participants

Timeframe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)

Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).

Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

Trial details

NCT IDNCT01920932

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-16

Results submitted2021-10-13

View on ClinicalTrials.gov More Stage II Childhood Hodgkin Lymphoma trials