November 26, 2018
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November 28, 2018
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April 4, 2024
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December 12, 2018
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January 1, 2027 (Final data collection date for primary outcome measure)
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- Response rate of adequate response [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
The 70 evaluable low-risk patients enrolled will be evaluated for this objective.
- Response rate of adequate response [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
The 65 evaluable intermediate-risk patients enrolled will be evaluated for this objective
- Event-free survival [ Time Frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment ]
Time to event defined as relapse, progression or death. The 115 evaluable high-risk patients participants enrolled will be evaluated for this objective.
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- Response rate of adequate response [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
The 70 evaluable low-risk patients enrolled will be evaluated for this objective.
- Response rate of adequate response [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
The 65 evaluable intermediate-risk patients enrolled will be evaluated for this objective
- Event-free survival [ Time Frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment ]
Time to event defined as relapse, progression or death. The 65 evaluable high-risk patients participants enrolled will be evaluated for this objective.
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- Number of adverse events in low-risk and intermediate-risk patients [ Time Frame: From enrollment to end of therapy (approximately 8 months ]
According to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
- Number of adverse events in high-risk patients [ Time Frame: From enrollment to end of therapy (approximately 8 months ]
According to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
- Local failure rate [ Time Frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment ]
Local failure rate in irradiated and non-irradiated patients
- Event-free survival [ Time Frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment ]
Time to event defined as relapse, progression or death. The EFS for the low-risk patients and intermediate-risk patients are compared to those in HOD08 and HOD05, respectively.
- Response rate [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
Response rate of adequate response after 2 cycles of AEPA in the high-risk patients with FDG-PET compared to that after 2 cycles of AEPA in HLHR13.
- Response rate [ Time Frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment ]
Response rate of adequate response after 2 cycles of BEABOVP in the low-risk and high-risk patients with FDG-PET compared to those after 2 cycles of STANFORD V chemotherapy in HOD08 and HOD05, respectively.
- Event-free survival [ Time Frame: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment ]
Time to event defined as relapse, progression or death. The EFS for the high-risk patients is compared to those in HLHR13.
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Same as current
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Not Provided
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Not Provided
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Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
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Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
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This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.
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PRIMARY OBJECTIVES
- To evaluate the efficacy (adequate response) after 2 cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in low-risk and intermediate-risk patients with classical Hodgkin lymphoma (cHL).
- To estimate the event-free survival in high-risk patients with classical Hodgkin lymphoma (cHL).
SECONDARY OBJECTIVES
- To describe the acute hematologic and infectious toxicities of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in patients with low-risk and intermediate- risk cHL as they relate to transfusion requirements, hematopoietic growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
- To describe the acute hematologic, neuropathic, and infectious toxicities of AEPA/CAPDac in patients with high-risk cHL as they relate to transfusion requirements, hematopoietic growth factor support, episodes of grade 3 and 4 sensory or motor neuropathy, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
- To evaluate patterns of failure in irradiated and non-irradiated patients.
- To estimate the EFS functions of LR and IR patients, and compare with those in previously published studies.
- To estimate the response rate in HR patients and compare with historical and literature rates.
- To compare response rates in LR and IR patients with historical and literature rates.
- To compare the EFS function of HR patients with that in previously published studies.
EXPLORATORY OBJECTIVES
Low-risk and Intermediate-risk: Low-risk patients will receive 2 cycles of BEABOVP and Intermediate-risk patients will receive 3 cycles of BEABOVP.
BEABOVP regimen: Patients will receive bendamustine day 1, etoposide day 15, Adriamycin® (doxorubicin) days 1 and 15, bleomycin days 8 and 22, Oncovin® (vincristine) days 8 and 22, vinblastine days 1 and 15, and prednisone two or three times per day every other day of each cycle for a total of 14 days of steroids.
High-risk patients will receive 2 cycles of AEPA and 4 cycles of CAPDac.
AEPA regimen: Patients will receive Adcedris® (brentuximab vedotin) days 1, 8 and 15, etoposide days 1 to 5, prednisone two or three times daily days 1 to 15 and Adriamycin® (doxorubicin) days 1 and 15.
CAPDac regimen: Patients will receive cyclophosphamide days 1 and 8, Adcetris® (brentuximab vedotin) days 1 and 8, prednisone two or three times daily days 1 to 15 and Dacarbazine® (DTIC) days 1 to 3.
Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups.
Steroids will be omitted after 2 cycles for any IR or HR patient with an AR after 2 cycles of therapy.
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Interventional
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Phase 2
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Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Hodgkin Lymphoma
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- Drug: bendamustine
Given intravenously (IV)
Other Name: TREANDA (R)
- Drug: Etoposide
Given intravenously (IV)
- Drug: Doxorubicin
Given intravenously (IV)
Other Name: Adriamycin (R)
- Drug: Bleomycin
Given intravenously (IV)
Other Name: Blenoxane (R)
- Drug: Vincristine
Given intravenously (IV)
Other Name: Oncovin (R)
- Drug: Vinblastine
Given intravenously (IV)
Other Name: Velban (R)
- Drug: Prednisone
Given orally (PO)
Other Name: Prednisolone
- Drug: Filgrastim
Given subcutaneously (SQ) or IV
Other Name: Neupogen (R)
- Drug: Brentuximab Vedotin
Given intravenously (IV)
Other Name: Adcetris
- Drug: Cyclophosphamide
Given intravenously (IV)
Other Name: Cytoxan (R)
- Drug: DTIC
Given intravenously (IV)
Other Names:
- DACARBAZINE (R)
- Dimethyl Triazeno Imidazole Carboximide
- Other: Quality of Life Measurements
Quality of Life measurements may be done in low-risk cycles 1 and 2 BEABOVP, intermediate-risk cycles 1, 2 and 3 BEABOVP and high-risk cycles 1 and 2 AEPA and cycles 1, 2, 3, and 4 CAPDac. QOL may be done at year 1, 2 and 5 for all risk groups.
Other Name: Quality of Life Measurements (QOL)
- Radiation: Radiotherapy
Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups. Radiotherapy will be administered after completion of all chemotherapy upon hematologic count recovery.
Other Names:
- radiation therapy
- irradiation
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- Experimental: Low-Risk
Participants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Interventions:
- Drug: bendamustine
- Drug: Etoposide
- Drug: Doxorubicin
- Drug: Bleomycin
- Drug: Vincristine
- Drug: Vinblastine
- Drug: Prednisone
- Drug: Filgrastim
- Other: Quality of Life Measurements
- Radiation: Radiotherapy
- Experimental: Intermediate-Risk
Participants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Interventions:
- Drug: bendamustine
- Drug: Etoposide
- Drug: Doxorubicin
- Drug: Bleomycin
- Drug: Vincristine
- Drug: Vinblastine
- Drug: Prednisone
- Drug: Filgrastim
- Other: Quality of Life Measurements
- Radiation: Radiotherapy
- Experimental: High-Risk
Participants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Interventions:
- Drug: Etoposide
- Drug: Doxorubicin
- Drug: Prednisone
- Drug: Filgrastim
- Drug: Brentuximab Vedotin
- Drug: Cyclophosphamide
- Drug: DTIC
- Other: Quality of Life Measurements
- Radiation: Radiotherapy
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Not Provided
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Recruiting
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250
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125
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July 1, 2028
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January 1, 2027 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
Exclusion Criteria:
- CD30 negative HL.
- Has received prior therapy for Hodgkin lymphoma
- Inadequate organ function
- High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active neurologic disease that would impede the ability to assess neurologic toxicities.
- Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.
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Sexes Eligible for Study: |
All |
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up to 25 Years (Child, Adult)
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No
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United States
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NCT03755804
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cHOD17 NCI-2018-02924 ( Registry Identifier: NCI Clinical Trial Registration Program )
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Not Provided
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St. Jude Children's Research Hospital
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Same as current
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St. Jude Children's Research Hospital
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Same as current
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- Teva Pharmaceuticals USA
- Seagen Inc.
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Principal Investigator: |
Matthew Ehrhardt, MD, MS |
St. Jude Children's Research Hospital |
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St. Jude Children's Research Hospital
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April 2024
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