Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
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| ClinicalTrials.gov Identifier: NCT03755804 |
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Recruitment Status :
Recruiting
First Posted : November 28, 2018
Last Update Posted : April 4, 2024
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Sponsor:
St. Jude Children's Research Hospital
Collaborators:
Teva Pharmaceuticals USA
Seagen Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hodgkin Lymphoma | Drug: bendamustine Drug: Etoposide Drug: Doxorubicin Drug: Bleomycin Drug: Vincristine Drug: Vinblastine Drug: Prednisone Drug: Filgrastim Drug: Brentuximab Vedotin Drug: Cyclophosphamide Drug: DTIC Other: Quality of Life Measurements Radiation: Radiotherapy | Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 |
| Actual Study Start Date : | December 12, 2018 |
| Estimated Primary Completion Date : | January 1, 2027 |
| Estimated Study Completion Date : | July 1, 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: bendamustine
Given intravenously (IV)
Other Name: TREANDA (R) Drug: Etoposide Given intravenously (IV)
Other Names:
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) 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:
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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.
|
Drug: bendamustine
Given intravenously (IV)
Other Name: TREANDA (R) Drug: Etoposide Given intravenously (IV)
Other Names:
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) 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:
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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.
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Drug: Etoposide
Given intravenously (IV)
Other Names:
Drug: Doxorubicin Given intravenously (IV)
Other Name: Adriamycin (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:
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:
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI).
- Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk
- Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their 26th birthday) for high-risk
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All Ann Arbor stages.
- Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)
- Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) and IB, IIIA.
- High-Risk: IIB, IIIB, IV
- Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted for age and gender as follows: Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for males and 0.6 mg/dL for females, Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for males and 0.8 mg/dL for females, Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females
- Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x ULN for age).
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Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease diagnosis
- Absolute neutrophil count (ANC) ≥1000/µL
- Platelets ≥ 75,000/µL
- Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or MUGA, unless decreased function is due to large mediastinal mass or effusion related to HL.
- Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 92% on room air unless secondary to a large mediastinal mass or effusion related to HL.
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755804
Contacts
| Contact: Matthew Ehrhardt, MD, MS | 866-278-5833 | referralinfo@stjude.org |
Locations
| United States, California | |
| Lucile Packard Children's Hospital Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Michael Link, MD 650-495-8815 mlink@stanford.edu | |
| Principal Investigator: Michael Link, MD | |
| United States, Illinois | |
| St. Jude Midwest Affiliate - Peoria | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| Contact: Pedro De Alarcon, MD 888-226-4343 pdealarc@uic.edu | |
| Principal Investigator: Pedro De Alarcon, MD | |
| United States, Louisiana | |
| St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center) | Recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| Contact: Jeffrey Deyo, MD, PhD 225-374-1485 jeff.deyo@stjude.org | |
| Principal Investigator: Jeffrey Deyo, MD, PhD | |
| United States, Maine | |
| Maine Children's Cancer Program | Recruiting |
| Scarborough, Maine, United States, 04074 | |
| Contact: Eric Larsen, MD 207-885-7565 larsee1@mmc.org | |
| Principal Investigator: Eric Larsen, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Alison M. Friedman, MD 617-726-2737 afriedmann@partners.org | |
| Principal Investigator: Alison M. Friedman, MD | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Angela M. Feraco, MD, MMSc 617-632-5508 Angela_Feraco@dfci.harvard.edu | |
| Principal Investigator: Angela M. Feraco, MD, MMSc | |
| United States, North Carolina | |
| St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Christine Bolen, MD 704-384-1900 cybolen@novanthealth.org | |
| Principal Investigator: Christine Bolen, MD | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Matthew Ehrhardt, MD, MS 866-278-5833 referralinfo@stjude.org | |
| Principal Investigator: Matthew Ehrhardt, MD, MS | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Teva Pharmaceuticals USA
Seagen Inc.
Investigators
| Principal Investigator: | Matthew Ehrhardt, MD, MS | St. Jude Children's Research Hospital |
Additional Information:
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT03755804 |
| Other Study ID Numbers: |
cHOD17 NCI-2018-02924 ( Registry Identifier: NCI Clinical Trial Registration Program ) |
| First Posted: | November 28, 2018 Key Record Dates |
| Last Update Posted: | April 4, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by St. Jude Children's Research Hospital:
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Hodgkin Lymphoma Pediatric Cancer Frontline Therapy Response Adapted Therapy Risk Adapted Therapy |
Additional relevant MeSH terms:
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Prednisolone Cyclophosphamide Bendamustine Hydrochloride Dacarbazine Doxorubicin Etoposide |
Vincristine Bleomycin Brentuximab Vedotin Vinblastine Imidazole Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic |