Status:
ACTIVE_NOT_RECRUITING
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Seagen Inc.
Conditions:
Stage II Childhood Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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. M...
Detailed Description
PRIMARY OBJECTIVES: * To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPD...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2028
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01920932
Start Date
August 12 2013
End Date
May 1 2028
Last Update
December 3 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
2
St. Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
3
Maine Children's Cancer Program (MCCP)
Scarborough, Maine, United States, 04704
4
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114