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A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079105
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE March 8, 2004
First Posted Date  ICMJE March 9, 2004
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE January 2004
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Disease-free survival by routine imaging [ Time Frame: 6 month intervals ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Overall survival by routine imaging [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
Official Title  ICMJE A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.

Detailed Description



  • Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
  • Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

  • Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
  • Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.

Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: bleomycin sulfate
    Other Name: Blenoxane
  • Drug: cyclophosphamide
    Other Name: Cytoxan
  • Drug: etoposide
    Other Names:
    • Eposin
    • Etopophos
    • Vepesid
  • Drug: mitoxantrone hydrochloride
    Other Name: Novantrone
  • Drug: prednisolone
    Other Names:
    • Flo-Pred
    • Pediapred
    • Orapred
  • Drug: procarbazine hydrochloride
    Other Name: Matulane
  • Drug: vinblastine sulfate
    Other Name: Vincristine
Study Arms  ICMJE
  • Active Comparator: Treatment
    Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
    • Biological: bleomycin sulfate
    • Drug: cyclophosphamide
    • Drug: etoposide
    • Drug: mitoxantrone hydrochloride
    • Drug: prednisolone
    • Drug: procarbazine hydrochloride
    • Drug: vinblastine sulfate
  • No Intervention: Registration
    Registration, without treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2015)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.

No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Exclusion criteria:

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.

Unable to give informed consent.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00079105
Other Study ID Numbers  ICMJE CDR0000354225
UON-SHIELD ( Other Identifier: Sponsor )
EU-20346 ( Other Identifier: Sponsor )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD were shared, nor will be, for this trial.
Current Responsible Party Newcastle-upon-Tyne Hospitals NHS Trust
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Newcastle-upon-Tyne Hospitals NHS Trust
Original Study Sponsor  ICMJE University of Newcastle Upon-Tyne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stephen J. Proctor, MD University of Newcastle Upon-Tyne
Study Director: Helen H. Lucraft, MD Northern Centre for Cancer Treatment at Newcastle General Hospital
Study Director: Katrina M. Wood, MD Sir James Spence Institute of Child Health at Royal Victoria Infirmary
PRS Account Newcastle-upon-Tyne Hospitals NHS Trust
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP