A Phase 2 interventional study of bleomycin sulfate and cyclophosphamide in Lymphoma, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Completed at 54 sites in 2 countries. Open to participants aged 60 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-03-30.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
OUTLINE: This is an open-label, multicenter study.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 175 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
Registration, without treatment
Treatment
Also known as: Blenoxane
Treatment
Also known as: Cytoxan
Treatment
Also known as: Eposin, Etopophos, Vepesid
Treatment
Also known as: Novantrone
Treatment
Also known as: Flo-Pred, Pediapred, Orapred
Treatment
Also known as: Matulane
Treatment
Also known as: Vincristine
Disease-free survival by routine imaging
Time frame: 6 month intervals
Overall survival by routine imaging
Time frame: 5 years
Plan to share: No — No IPD were shared, nor will be, for this trial.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Newcastle-upon-Tyne Hospitals NHS Trust