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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01026220
First received: December 3, 2009
Last updated: April 18, 2017
Last verified: February 2017
  Purpose
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

Condition Intervention Phase
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma Stage III Childhood Hodgkin Lymphoma Stage IV Childhood Hodgkin Lymphoma Biological: bleomycin sulfate Drug: doxorubicin hydrochloride Drug: liposomal vincristine sulfate Drug: vinorelbine tartrate Drug: cyclophosphamide Drug: etoposide phosphate Drug: prednisone Biological: filgrastim Drug: ifosfamide Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Second-event-free Survival [ Time Frame: At 4 years from enrollment ]
    Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

  • Safety Analysis and Monitoring of Toxic Death [ Time Frame: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months). ]
    The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.


Secondary Outcome Measures:
  • Event Free Survival [ Time Frame: At 3 years from enrollment ]
    Survival from enrollment to first event: relapse/progression, second malignancy, or death.

  • Second-event-free Survival [ Time Frame: At 4 years from enrollment ]
    Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.

  • Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative [ Time Frame: 3 years from enrollment ]
    To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.

  • Relapse-free Survival [ Time Frame: 3 years from enrollment ]
    A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.

  • Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy [ Time Frame: During and after completion of study treatment. ]
    The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.

  • Overall Survival [ Time Frame: At 3 years from enrollment ]
    Survival from enrollment to death.


Enrollment: 166
Study Start Date: December 2009
Study Completion Date: September 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen I (consolidation therapy)
Patients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.
Biological: bleomycin sulfate
Given IV or SC
Other Names:
  • Blenoxane
  • BLEO
  • BLM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Experimental: Regimen II (consolidation therapy)
Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
Biological: bleomycin sulfate
Given IV or SC
Other Names:
  • Blenoxane
  • BLEO
  • BLM
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: vinorelbine tartrate
Given IV
Other Names:
  • Eunades
  • navelbine ditartrate
  • NVB
  • VNB
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: ifosfamide
Given IV
Other Names:
  • Cyfos
  • Holoxan
  • IFF
  • IFX
  • IPP
Experimental: Induction: all patient
All patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: liposomal vincristine sulfate
Given IV
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:

    • Classical disease
    • Nodular lymphocyte-predominant disease
  • Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:

    • Unexplained weight loss > 10% within the past 6 months
    • Unexplained recurrent fever > 38°C within the past month
    • Recurrent drenching night sweats within the past month
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:

    • 0.4 mg/dL (1 to 5 months)
    • 0.5 mg/dL (6 to 11 months)
    • 0.6 mg/dL (12 to 23 months)
    • 0.8 mg/dL (2 to 5 years)
    • 1 mg/dL (6 to 9 years)
    • 1.2 mg/dL (10 to 12 years)
    • 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
    • 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)
  • FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)

    • For children who are unable to cooperate for PFTs, the criteria are:

      • No evidence of dyspnea at rest
      • No exercise intolerance
      • Pulse oximetry > 92% on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG
  • No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
  • At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
  • No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)

    • Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
  • No concurrent pegfilgrastim
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026220

  Show 177 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kara Kelly, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01026220     History of Changes
Other Study ID Numbers: AHOD0831
NCI-2011-01994 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000660550
AHOD0831 ( Other Identifier: Children's Oncology Group )
AHOD0831 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
Study First Received: December 3, 2009
Results First Received: February 8, 2017
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Etoposide phosphate
Vinorelbine
Doxorubicin
Prednisone
Etoposide
Vincristine
Bleomycin
Lenograstim
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

ClinicalTrials.gov processed this record on July 26, 2017