Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
134

Inclusion Criteria

Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
...
Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender.
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 enrollment (i.e., participants are eligible until their 19th birthday).
Ann Arbor stage IIB, IIIB, IVA, or IVB.

Exclusion Criteria

Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
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.
Has received prior therapy for Hodgkin lymphoma, except as noted above.
Inadequate organ function as described above.
CD30 negative HL.

Summary

Conditions
  • Stage II Childhood Hodgkin Lymphoma
  • Stage III Childhood Hodgkin Lymphoma
  • Stage IV Childhood Hodgkin Lymphoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 18 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk...

PRIMARY OBJECTIVES: To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL). To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study. SECONDARY OBJECTIVES: To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA. To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL. To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure). To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study. OUTLINE: AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Inclusion Criteria

Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
...
Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender.
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 enrollment (i.e., participants are eligible until their 19th birthday).
Ann Arbor stage IIB, IIIB, IVA, or IVB.

Exclusion Criteria

Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
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.
Has received prior therapy for Hodgkin lymphoma, except as noted above.
Inadequate organ function as described above.
CD30 negative HL.

Locations

Peoria, Illinois, 61637
Memphis, Tennessee, 38105
Palo Alto, California, 94304
Boston, Massachusetts, 02115
Scarborough, Maine, 04704
...
Peoria, Illinois, 61637
Memphis, Tennessee, 38105
Palo Alto, California, 94304
Boston, Massachusetts, 02115
Scarborough, Maine, 04704
Boston, Massachusetts, 02114

Tracking Information

NCT #
NCT01920932
Collaborators
Seagen Inc.
Investigators
  • Principal Investigator: Monika Metzger, MD, MSc St. Jude Children's Research Hospital
  • Monika Metzger, MD, MSc St. Jude Children's Research Hospital