eagle-i University of Hawaii at ManoaUniversity of Hawaii at Manoa
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Non-randomized phase III study of response adapted therapy for the treatment of children with newly diagnosed high risk Hodgkin lymphoma

eagle-i ID

http://hawaii.eagle-i.net/i/00000130-c43d-d16c-eee5-4adc80000000

Resource Type

  1. Clinical trial

Properties

  1. ClinicalTrials.gov url
    http://clinicaltrials.gov/ct2/show/NCT01026220?term=NCT01026220&rank=1
  2. Intervention
    ABVE-PC
  3. Intervention
    Ifosfamide/vinorelbine
  4. Intervention
    Radiation therapy
  5. Additional Topic(s)
    Drug administration and dosage
  6. Resource Description
    In this trial, the hybrid regimen ABVE-PC*, modified from both DBVE-PC regimen of POG 9425 and BEACOPP of CCG 59704 will be utilized. This study will attempt to achieve optimal balance by using a regimen that is more dose dense (dose intensity per week) than POG 9425, but less dose intensive (cumulative dose of chemotherapy) than CCG 59704. We will test a response-based approach wherein rapid early responders (RER) to the first 2 cycles of ABVE-PC* will be treated with 2 additional cycles of ABVE-PC* and risk-adapted radiation therapy (RT), whereas slow early responders (SER) will receive 2 cycles of ifosfamide/vinorelbine (IFOS/VINO) (a combination proven to be effective in the AHOD00P1 study) in addition to 2 more cycles of ABVE-PC* and risk-adapted RT. Since a subset of patients with high risk HL can be successfully cured with retrieval therapy, this study will test the hypothesis that this regimen will result in excellent long term "second event" free survival.
  7. Contact
    Berenberg, Jeffrey
  8. PI
    Wilkinson, Robert, M.D.
  9. Topic
    Hodgkin's lymphoma
  10. Study Population
    Males and females ages 0-21 years inclusive. Patients with newly diagnosed, pathologically confirmed classical Hodgkin lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma meeting one of the following clinical stages are eligible: 1) All Stage III with B symptoms 2) All Stage IV with B symptoms.
  11. Website(s)
    http://www.cancer.gov/clinicaltrials/search/view?cdrid=660550&version=healthprofessional
  12. Funded by
    Children's Oncology Group
  13. Phase
    Phase 3 clinical trial
  14. Performed by
    Clinical Protocol & Data Management Shared Resource
 
RDFRDF
 
Provenance Metadata About This Resource Record
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The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016