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Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

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ClinicalTrials.gov Identifier: NCT03755804
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
Teva Pharmaceuticals USA
Seattle Genetics, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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
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. 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 will be done.
Drug: bendamustine
Given intravenously (IV)
Other Name: TREANDA (R)

Drug: Etoposide
Given intravenously (IV)
Other Names:
  • VP-16
  • Vepeside

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 will 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 will 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

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. 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 will be done.
Drug: bendamustine
Given intravenously (IV)
Other Name: TREANDA (R)

Drug: Etoposide
Given intravenously (IV)
Other Names:
  • VP-16
  • Vepeside

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 will 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 will 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

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. 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 will be done.
Drug: Etoposide
Given intravenously (IV)
Other Names:
  • VP-16
  • Vepeside

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:
  • DACARBAZINE (R)
  • Dimethyl Triazeno Imidazole Carboximide

Other: Quality of Life Measurements
Quality of Life measurements will 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 will 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




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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 21 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 ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday) for high-risk
  • 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).
  • 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, 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 in the opinion of the treating investigator, would impede 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
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Contact: Jamie Flerlage, MD, MS 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jamie Flerlage, MD, MS    866-278-5833    referralinfo@stjude.org   
Sponsors and Collaborators
St. Jude Children's Research Hospital
Teva Pharmaceuticals USA
Seattle Genetics, Inc.
Investigators
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Principal Investigator: Jamie Flerlage, MD, MS St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03755804     History of Changes
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: December 31, 2018
Last Verified: December 2018

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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:
Hodgkin Lymphoma
Pediatric Cancer
Frontline Therapy
Response Adapted Therapy
Risk Adapted Therapy

Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Bendamustine Hydrochloride
Dacarbazine
Doxorubicin
Liposomal doxorubicin
Prednisone
Etoposide
Etoposide phosphate
Vincristine
Bleomycin
Vinblastine
Lenograstim
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists